Active pre-exposure immunisation against hepatitis B virus: immunogenicity of hepatitis B vaccine in healthy Thai adults and children. Newborn universal immunisation against hepatitis B: immunogenicity and reactogenicity of simultaneous administration of diphtheria/tetanus/pertussis (DTP) and oral polio vaccines with hepatitis B vaccine at 0, 2 and 6 months of age. Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors Long-term efficacy of plasma-derived hepatitis B vaccine: a 15-year follow-up study among Chinese children. Placebo-controlled trial of vaccination with hepatitis B virus surface antigen in hepatitis B virus transgenic mice. Prevention of perinatal acquisition of hepatitis B virus carriage using vaccine: preliminary report of a randomized, double-blind placebo-controlled and comparative trial. Acute hepatitis B virus infection: relation of age to the clinical expression of disease and subsequent development of the carrier state. Hepatitis B vaccine: demonstration of efficacy in a controlled clinical trial in a high-risk population in the United States. Literature searching for randomized controlled trials used in Cochrane reviews: rapid versus exhaustive searches. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. [Efficacy and immune memory of plasma-derived hepatitis B vaccine 11 years after primary immunization]. Immune response to hepatitis B vaccine in parenteral drug abusers. Design and compliance of HBV vaccination trial on newborns to prevent hepatocellular carcinoma and 5-year results of its pilot study. Immune response to hepatitis B vaccine in infants and newborns: control trial in an endemic area (Senegal). EFFICACY OF HEPATITIS B VACCINE IN PREVENTION OF EARLY HBsAg CARRIER STATE IN CHILDREN: Controlled Trial in an Endemic Area (Senegal) Immunogenicity in humans of an edible vaccine for hepatitis B. Multicenter study on the immunogenicity and safety of two recombinant vaccines against hepatitis B. Simultaneous vaccination against hepatitis A and B: results of a controlled study. Comparative study of the immunogenicity and safety of two dosing schedules of hepatitis B vaccine in neonates. [Vaccination against hepatitis B: 3 years' experience at the Latium Operative Unit]. The effect of concurrent use of hepatitis B and Bacille Calmette-Guérin vaccination on anti-hepatitis B response. Immunogenicity and safety of an adjuvanted hepatitis B vaccine in pre-hemodialysis and hemodialysis patients. Clinical and immunological investigation of a new combined hepatitis A and hepatitis B vaccine. Intradermal vaccination against hepatitis B virus infection in an endemic area (Nigeria), two year results [Long-term efficacy of plasma-derived hepatitis B vaccine among Chinese children--a 12-year follow-up]. Immune response to simultaneous administration of a recombinant DNA hepatitis B vaccine and multiple compulsory vaccines in infancy. [Evaluation of long-term efficacy on plasma-derived hepatitis B vaccine]. Immunogenicity of a recombinant, yeast-derived, anti-hepatitis-B vaccine after alternative dosage and schedule vaccination in Pakistani children. Efficacy trial of heat-inactivated hepatitis B vaccine (CLB) in male homosexuals in the Netherlands. Efficacy of a heat inactivated hepatitis B vaccine in male homosexuals: outcome of a placebo controlled double blind trial. 18-year follow-up study of a prospective randomized trial of hepatitis B vaccinations without booster doses in children. Efficacy of hepatitis B vaccine in the Gambian expanded programme on immunisation Immunogenicity of low-dose intramuscular and intradermal vaccination with recombinant hepatitis B vaccine. Hepatitis B immunization of newborns according to a two dose protocol. The development of cirrhosis in patients with chronic type B hepatitis: a prospective study. [Evaluation of the effectiveness nine years after primary immunization with local produced plasma-derived hepatitis B vaccine]. Comparative immunogenicity study of four plasma-derived hepatitis B vaccines in Thai young adults. Booster response to recombinant yeast-derived hepatitis B vaccine in vaccinees whose anti-HBs responses were initially elicited by a plasma-derived vaccine. IMMUNISATION AGAINST HEPATITIS B IN MAN Integration of hepatitis B vaccination into the expanded programme on immunization in Chonburi and Chiangmai provinces, Thailand. [Safety and immunogenicity of an anti-hepatitis-B vaccine obtained using the recombinant DNA technique: results of a longitudinal study in hospital personnel].
The immunogenicity of plasma derived hepatitis B vaccine ( Hevac B ) was studied for active pre-exposure immunisation in 176 healthy volunteer adults and 162 r and omised children who had no hepatitis B virus markers . All subjects received three injections of 5 micrograms of hepatitis B vaccine intramuscularly at one month intervals . Seroconversion at 2 months after the third dose of vaccine was 96.30 percent in the children and 92.00 percent in the adults with mean anti-HBs titres of 800 mlU/ml and 353 mlU/ml respectively . The difference of anti-HBs levels between these two groups was statistically significant ( p less than 0.05 ) . Female adults had exhibited higher immune response to HB vaccine than male adults but there was no seroconversion difference between boys and girls . There were no serious local or systemic side effects of hepatitis B vaccination . It was concluded that active immunisation with plasma derived hepatitis B vaccine in non-immune children and adults is highly effective without any serious side effects or complications . The prevention of horizontal transmission of hepatitis B virus should be done by vaccination in children since they have a much better immune response to hepatitis B vaccine than adults The reactogenicity and immunogenicity of the administration of recombinant vaccine against hepatitis B simultaneously ( but at separate sites ) with diphtheria/tetanus/pertussis ( DTP ) and oral polio vaccines were examined . Six hundred and twenty-six children ( group I ) were given hepatitis B vaccine at 0 , 2 and 6 months of age ; the other vaccines were administered at 2 , 4 and 6 months of age . A control group of 731 children ( group II ) received only DTP and oral polio vaccines . The results showed that 93 % of the infants in group I had anti-HBs titres above the protective level ( > or = 10 mIU ml-1 ) after vaccination . There were no differences in the immune responses for DTP and polio between the two study groups . The vaccine efficacy against poliomyelitis was 96 % for serotype I , 100 % for serotype II and 97 - 98 % for serotype III . Of the infants in both groups , 97 % had antibodies against B. pertussis ; all children were positive for tetanus and diphtheria . There were no differences in the incidences of general reactions between groups . Local swelling and redness were reported following 4.2 and 4.4 % , respectively , of all injections of hepatitis B vaccine . These reactions were reported following 31 and 33 % , respectively , of all doses of DTP vaccine . It can be concluded that the simultaneous administration of hepatitis B vaccine with the DTP and polio vaccines is well-tolerated ; hepatitis B vaccine remained highly immunogenic and did not interfere with the immune response to the other antigens Abstract Objective To examine the extent and nature of outcome reporting bias in a broad cohort of published r and omised trials . Design Retrospective review of publications and follow up survey of authors . Cohort All journal articles of r and omised trials indexed in PubMed whose primary publication appeared in December 2000 . Main outcome measures Prevalence of incompletely reported outcomes per trial ; reasons for not reporting outcomes ; association between completeness of reporting and statistical significance . Results 519 trials with 553 publications and 10 557 outcomes were identified . Survey responders ( response rate 69 % ) provided information on unreported outcomes but were often unreliable — for 32 % of those who denied the existence of such outcomes there was evidence to the contrary in their publications . On average , over 20 % of the outcomes measured in a parallel group trial were incompletely reported . Within a trial , such outcomes had a higher odds of being statistically non-significant compared with fully reported outcomes ( odds ratio 2.0 ( 95 % confidence interval 1.6 to 2.7 ) for efficacy outcomes ; 1.9 ( 1.1 to 3.5 ) for harm outcomes ) . The most commonly reported reasons for omitting efficacy outcomes included space constraints , lack of clinical importance , and lack of statistical significance . Conclusions Incomplete reporting of outcomes within published articles of r and omised trials is common and is associated with statistical non- significance . The medical literature therefore represents a selective and biased subset of study outcomes , and trial protocol s should be made publicly available To determine necessity and timing of booster of hepatitis B vaccine , we need to observe the duration of its protection . We report the results of a 15-year follow-up of a cohort of 649 children who participated a r and omized , double blind , placebo-controlled trial on a plasma-derived hepatitis B vaccine in 1982 . During the 15 years after vaccination , more vaccinated children had anti-HBs of 10 S/N ratios or over , compared with the controls , at all nine observations . At 15 years 50.0 % ( 26/52 ) of the participants studied in the vaccinated group and 33.3 % of the tested controls ( 18/54 ) retained anti-HBs levels of S/N ratios > or = 10 ( P < 0.09 ) . However , since 5 years after vaccination , median S/N ratios of anti-HBs among the vaccinated children with detectable anti-HBs were lower than those of the controls except that detected at 15 years . 16.7 % ( 9/54 ) of the tested children in the control group were HBsAg positive at 15 years after vaccination , in comparison with 1.9 % ( 1/52 ) of the tested children in the vaccinated ( P < 0.02 ) . 28 chronic HBsAg carriers were identified in the control cohort over the 15 years , whereas only 1 case was noted in the vaccinated group ( 8.2 % vs. 0.3 % , P < 0.00001 ) , corresponding to an efficacy of 96 % BACKGROUND / AIMS Treatment of hepatitis B virus carriers by vaccine containing hepatitis B surface antigen with Pre-S protein and HBsAg/ anti-HBs complex has been reported and these studies have constituted a new and promising concept for the treatment of HBV-carriers . The present communication , a placebo-controlled trial of vaccination in HBV-transgenic mice , was design ed to examine the impact of vaccination using a high dose of HBsAg for a duration of 12 months to achieve further insights about the dose , duration and effectiveness of vaccine therapy . Another aim of this study was to analyse the mechanism underlying the antiviral and immunomodulatory potentiality of vaccine therapy in HBV-transgenic mice . METHODS HBV-transgenic mice positive for HBV DNA , hepatitis B surface antigen and hepatitis B e antigen in sera received either HBV-vaccine containing HBsAg in complete Freund 's adjuvant ( CFA ) , intraperitoneally , once a month for 12 consecutive months ( vaccine recipients ) , or only CFA , intraperitoneally once in a month for 12 consecutive months ( placebo recipients ) . Thirty-two vaccine-recipient and 16 placebo-recipient HBV-transgenic mice were injected , checked and followed on a monthly basis for the entire duration of 12 months . RESULTS Of the 32 transgenic mice from the vaccine-recipient group , 25 became completely negative for HBsAg and 30 for HBeAg . Five mice developed anti-HBs in sera after the observation period of 12 months . Semiquantitative estimation of HBV DNA by polymerase chain reaction showed that vaccination result ed in a decrease of HBV DNA in sera . Placebo-recipient transgenic mice did not show any significant change in the titres of HBV markers after receiving 12 monthly injections of CFA . Interleukin-2 could be detected in sera from vaccine-recipient transgenic mice , but not in placebo-recipient transgenic mice . CONCLUSIONS Vaccination with a high dose of HBsAg in adjuvant over a long period had a significant antiviral as well as immunomodulatory potential in HBV-transgenic mice . This inspires optimism that vaccine alone or in combination with antiviral agents can be used successfully for the treatment of human HBV-carriers Hepatitis B is a serious disease of global significance . In developing countries , hepatitis B virus ( HBV ) infection and its sequelae rank among the public health problems of highest priority . Infants born to mothers who are chronic carriers of HBV are at particularly high risk of acquiring infection and becoming chronic HBV carriers . The efficacy of hepatitis B vaccine alone in preventing the transmission of HBV to infants born to HBV carrier mothers was determined in a double-blind placebo-controlled trial . Infants received plasma-derived vaccine at birth , 1 month , and 6 months of age . Of 180 infants born to hepatitis B surface antigen (HBsAg)-positive mothers , equal numbers received National Institute of Allergy and Infectious Disease ( NIAID ) vaccine , Beijing Institute of Vaccine and Serum ( BIVS ) vaccine , and placebo . The cumulative seroconversion to the vaccines at 1 year of age was 95 % and 75 % , respectively . Vaccine efficacy as measured by the prevention of HBsAg-positive events was 88 % for the NIAID vaccine and 51 % for the BIVS vaccine . Vaccine efficacy was similar among infants born to hepatitis Be antigen-positive mothers . Because of the low efficacy of the BIVS vaccine , an additional group of 28 infants was given vaccine and hepatitis B immune globulin at birth . The result ing efficacy was 83 % . The results of this trial indicate that hepatitis B vaccine alone can substantially reduce perinatally acquired HBV infection and the result ing chronic carrier state Yupik Eskimos of southwestern Alaska have the highest known prevalence of hepatitis B virus infection of any general population in the United States . Prospect i ve serological surveys of 1,280 seronegative Yupik Eskimos , performed between 1971 and 1976 , identified 189 ( 14.8 % ) who developed serological evidence of hepatitis B virus infection .  Twenty-six ( 13.8 % ) developed clinical hepatitis during the interval when seroconversion occurred . The proportion of patients with clinical ly apparent hepatitis increased with age ( P less than .01 ) , ranging from 9.5 % of infections in patients who were four years of age or less to 33.3 % of infections in patients who were 30 years of age or older . Twenty-five ( 13.3 % ) of the 188 individuals who were studied became chronic carriers of hepatitis B surface antigen . The risk of becoming a carrier was inversely related to the age of the patient at the time of infection ( P = .02 ) . Among patients who were four years of age or less when infected , 28.8 % became chronic carriers of hepatitis B , as compared with 7.7 % of those who were 30 years of age or older We assessed the efficacy of an inactivated hepatitis B vaccine in a placebo-controlled , r and omized , double-blind trial in 1083 homosexual men known to be at high risk for hepatitis B virus infection . The vaccine was found to be safe and the incidence of side effects was low . Within two months , 77 % of the vaccinated persons had high levels of antibody against the hepatitis B surface antigen . This rate increased to 96 % after the booster dose and remained essentially unchanged for the duration of the trial . For the first 18 months of follow-up , hepatitis B or sub clinical infection developed in only 1.4 to 3.4 % of the vaccine recipients as compared with 18 to 27 % of placebo recipients ( P < 0.0001 ) . The reduction of incidence in the vaccinees was as high as 92.3 % ; none of the vaccinees with a detectable immune response to the vaccine had clinical hepatitis B or asymptomatic antigenemia . A significant reduction of incidence was already seen within 75 days after r and omization ; this observation suggests that the vaccine may be efficacious even when given after exposure OBJECTIVES To analyze sources search ed in Cochrane review s , to determine the proportion of trials included in review s that are indexed in major data bases , and to compare the quality of these trials with those from other sources . METHODS All new systematic review s in the Cochrane Library , Issue1 2001 , that were restricted to r and omized controlled trials ( RCTs ) or quasi- RCTs were selected . The sources search ed in the review s were recorded , and the trials included were checked to see whether they were indexed in four major data bases . Trials not indexed were checked to determine how they could be identified . The quality of trials found in major data bases was compared with those found from other sources . RESULTS The range in the number of data bases search ed per review ranged between one and twenty-seven . The proportion of the trials in the four data bases were Cochrane Controlled Trials Register = 78.5 % , MEDLINE = 68.8 % , Embase = 65.0 % , and Science/Social Sciences Citation Index = 60.7 % . Search ing another twenty-six data bases after Cochrane Controlled Trials Register ( CCTR ) , MEDLINE , and Embase only found 2.4 % additional trials . There was no significant difference between trials found in the CCTR , MEDLINE , and Embase compared with other trials , with respect to adequate allocation concealment or sample size . CONCLUSIONS There was a large variation between review s in the exhaustiveness of the literature search es . CCTR was the single best source of RCTs . Additional data base search ing retrieved only a small percentage of extra trials . Contacting authors and manufacturers to find unpublished trials appeared to be a more effective method of obtaining the additional better quality trials CONTEXT Selective reporting of outcomes within published studies based on the nature or direction of their results has been widely suspected , but direct evidence of such bias is currently limited to case reports . OBJECTIVE To study empirically the extent and nature of outcome reporting bias in a cohort of r and omized trials . DESIGN Cohort study using protocol s and published reports of r and omized trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg , Denmark , in 1994 - 1995 . The number and characteristics of reported and unreported trial outcomes were recorded from protocol s , journal articles , and a survey of trialists . An outcome was considered incompletely reported if insufficient data were presented in the published articles for meta- analysis . Odds ratios relating the completeness of outcome reporting to statistical significance were calculated for each trial and then pooled to provide an overall estimate of bias . Protocol s and published articles were also compared to identify discrepancies in primary outcomes . MAIN OUTCOME MEASURES Completeness of reporting of efficacy and harm outcomes and of statistically significant vs nonsignificant outcomes ; consistency between primary outcomes defined in the most recent protocol s and those defined in published articles . RESULTS One hundred two trials with 122 published journal articles and 3736 outcomes were identified . Overall , 50 % of efficacy and 65 % of harm outcomes per trial were incompletely reported . Statistically significant outcomes had a higher odds of being fully reported compared with nonsignificant outcomes for both efficacy ( pooled odds ratio , 2.4 ; 95 % confidence interval [ CI ] , 1.4 - 4.0 ) and harm ( pooled odds ratio , 4.7 ; 95 % CI , 1.8 - 12.0 ) data . In comparing published articles with protocol s , 62 % of trials had at least 1 primary outcome that was changed , introduced , or omitted . Eighty-six percent of survey responders ( 42/49 ) denied the existence of unreported outcomes despite clear evidence to the contrary . CONCLUSIONS The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocol s. Published articles , as well as review s that incorporate them , may therefore be unreliable and overestimate the benefits of an intervention . To ensure transparency , planned trials should be registered and protocol s should be made publicly available prior to trial completion OBJECTIVE To evaluate the long-term efficacy of  hepatitis B vaccine 10 years after primary immunization to provide scientific basis for the time of revaccination . METHODS The study was strictly design ed with r and omization , double-blinding , and placebo-controlled method to observe the efficacy and  immune memory 11 years following hepatitis B vaccination .  RESULTS Immunogenicity and protective rate of vaccine were still kept well 11 years after immunization with a protective rate against HBV infection of 73.5 % . But , there was no significant difference in HBV infection rates between vaccine group and placebo-controlled group ( 7.89 % vs. 13.25 % , P > 0.1 ) nine to 11 years following immunization . There still existed immune memory 11 years after immunization , but it was significantly weaker than that within the first 10 years after immunization . CONCLUSION The efficacy of the vaccine had begun to drop 11 years after immunization , which should be followed up further to reach a clear conclusion Responsiveness was assessed to a programme of vaccination of hepatitis B vaccine in a cohort of 197 intravenous drug addicts ( mean age , 23.7 years ) and their antibody response was compared with that of 271 healthy controls ( mean age , 24.2 years ) . All participants were seronegative for hepatitis B surface antigen ( HBsAg ) and antibody to HBsAg ( anti-HBs ) . The vaccination schedule consisted of three intramuscular injections ( deltoid area ) at months 0 , 1 and 2 . Although 70 % of parenteral drug abusers received the three doses of vaccination , only 43.6 % were evaluable for immune response . Fifty-eight per cent of heroin addicts and 80 % of controls had evidence of anti-HBs seroconversion at 1 month after vaccination ( chi 2 = 15.52 , p less than 0.001 ) . Geometric mean antibody titres were also significantly higher in controls ( 69.1 IU l-1 ; confidence interval 95 % , 56.83 and 84.04 ) than in parenteral drug abusers ( 18.2 IU l-1 ; confidence interval 95 % , 12.85 and 25.73 ) ( F = 20.951 , p less than 0.0001 ) . The anti-HBs response was not influenced by coexistent anti-HBc , HCV antibody or HIV antibody seropositivity A large-scale , controlled study of universal immunization of newborns against HBV infection has been conducted in the high incidence area of hepatocellular carcinoma , Qidong County of China . This area has a stable population , st and ardized cancer registration system , and an epidemiological base for measurements of liver cancer prevention by vaccine . R and omization was done on the community level . The vaccination and the  control  group each will consist of 38,000 children by the end of 1990 . It is anticipated that the design will provide high statistical power to detect 50 % reduction in the prevalence rate of chronic hepatitis among the vaccinees vs. the controls at 6 to 10 years of age , and 50 % reduction in the incidence rate of hepatocellular carcinoma at 35 to 40 years of age . The vaccine used is Hep-B Vax , donated by Merck and Co. through WHO . The vaccine was administered at 0 , 1 , and 6 months after birth , the dosage of 5 or 2.5 micrograms in the pilot study as used before 1985 and of 5 micrograms dose level during the main study starting from January 1 , 1985 . About 85 % of the cohorts have now entered the protocol . The vaccination coverage during 1984 to 1989 was 98.0 % ( 35,064/35,789 ) . Follow-up of the vaccinees and the age-matched controls at 5 years has exceeded 97 % . The cumulative mortality in the vaccinated group up to 1988 was 1.29 % ( 354/27,450 ) . No single death nor serious adverse reaction was found that was associated with vaccination . The use of HBV vaccine at a reduced dose was especially important for the developing countries at the present time in order to achieve widespread immunization . Five-year results of the pilot study of this vaccination project showed that significant protection against HBV infection was achieved with the 5 or 2.5 micrograms per dose regimen plus a booster of 5 micrograms given at 3.5 to 4 years of age . ( ABSTRACT TRUNCATED AT 250 WORDS In 1978 it was suggested that hepatitis B ( HB ) vaccine should be used to prevent the early hepatitis B surface antigen ( HBsAg ) carrier state in children . Immunization was effected by 3 injections of HB vaccine at one-month intervals followed by a booster injection after one year . Children in a control group were immunized with DT-polio vaccine according to the same schedule . The anti-HBs response of the children to HB vaccination was studied in relation to their hepatitis B virus ( HBV ) serum markers prior to immunization . Of the seronegative children , 70.5 % responded to immunization after 2 injections of 5- g doses of HB vaccine and 94 % after the third injection . The efficacy of the vaccine was demonstrated by comparison of HB events after one year in 309 seronegative children immunized with HB vaccine and 252 seronegative children immunized with DT-polio vaccine , and after two years in 101 and 119 children , respectively . The incidence of the HBsAg carrier state was reduced by 80 % in susceptible children . In order to eliminate the perinatal transmission occurring in newborns with HBsAg-positive mothers , a study of immunization at birth has been instituted . A total of 86 newborns responded to the vaccination as well as older children , irrespective of the HBV status of their mothers . After one year , the incidence of the HBsAg carrier state was reduced by 80 % . In Africa , immunization teams have a limited amount of time to devote to each rural community . The immunogenic effect of 2 doses of HB vaccine given at an interval of 2 or 6 months has therefore been investigated . All were given a booster dose one year after the first injection of vaccine . No difference was observed in the seroconversion rate or in the anti-HBs titres as between the two protocol s. These results demonstrate that 2 doses of 5 micrograms of HB vaccine are sufficient to obtain a high immunogenic effect in infants . In addition , an investigation was carried out on the immune response to HBsAg and tetanus toxoid antigen when administered simultaneously to children as HB vaccine and DT-polio vaccine . The immune response was at least equal to that observed after administration of these vaccines separately Three doses of inactivated hepatitis B vaccine were given at one-month intervals to Senegalese children aged less than two years . A control group received diphtheria/tetanus/polio vaccine . Of those HB vaccine recipients who were seronegative before immunisation , 94.5 % had a specific anti-HBs response . Anti-HBs of maternal origin did not interfere with the active immunisation . HB vaccine was without ill-effects , irrespective of hepatitis B marker status before immunisation . After twelve months ' follow-up , the incidence of the HBsAg carrier state was reduced by 85 % in susceptible children ( p less than 0.0001 ) A double-blind placebo-controlled clinical trial evaluated the immunogenicity of hepatitis B surface antigen ( HBsAg ) expressed in potatoes and delivered orally to previously vaccinated individuals . The potatoes accumulated HBsAg at approximately 8.5 microg/g of potato tuber , and doses of 100 g of tuber were administered by ingestion . The correlate of protection for hepatitis B virus , a nonenteric pathogen , is blood serum antibody titers against HBsAg . After volunteers ate uncooked potatoes , serum anti-HBsAg titers increased in 10 of 16 volunteers ( 62.5 % ) who ate three doses of potatoes ; in 9 of 17 volunteers ( 52.9 % ) who ate two doses of transgenic potatoes ; and in none of the volunteers who ate nontransgenic potatoes . These results were achieved without the coadministration of a mucosal adjuvant or the need for buffering stomach pH. We conclude that a plant-derived orally delivered vaccine for prevention of hepatitis B virus should be considered as a viable component of a global immunization program The immunogenicity and safety of a new recombinant hepatitis B vaccine from the Instituto Butantan ( Butang ) were evaluated in a multicenter , double-blind , prospect i ve equivalence study in three centers in Brazil . Engerix B was the st and ard vaccine . A total of 3937 subjects were recruited and 2754 ( 70 % ) met all protocol criteria at the end of the study . All the subjects were considered healthy and denied having received hepatitis B vaccine before the study . Study subjects who adhered to the protocol were newborn infants ( 566 ) , children 1 to 10 years old ( 484 ) , adolescents from 11 to 19 years ( 740 ) , adults from 20 to 30 years ( 568 ) , and adults from 31 to 40 years ( 396 ) .  Vaccine was administered in three doses on the schedule 0 , 1 , and 6 months ( newborn infants , adolescents , and adults ) or 0 , 1 , and 7 months ( children ) . Vaccine dose was intramuscular 10 microg ( infants , children , and adolescents ) or 20 microg ( adults ) . Percent seroprotection ( assumed when anti-HBs titers were > 10 mIU/ml ) and geometric mean titer ( mIU/ml ) were : newborn infants , 93.7 % and 351.1 ( Butang ) and 97.5 % and 1530.6 ( Engerix B ) ; children , 100 % and 3600.0 ( Butang ) and 97.7 % and 2753.1 ( Engerix B ) ; adolescents , 95.1 % and 746.3 ( Butang ) and 96 % and 1284.3 ( Engerix B ) ; adults 20 - 30 years old , 91.8 % and 453.5 ( Butang ) and 95.5 % and 1369.0 ( Engerix B ) ; and adults 31 - 40 years old , 79.8 % and 122.7 ( Butang ) and 92.4 % and 686.2 ( Engerix B ) . There were no severe adverse events following either vaccine . The study concluded that Butang was equivalent to Engerix B in children , and less immunogenic but acceptable for use in newborn infants , adolescents , and young adults Hepatitis A and hepatitis B are endemic in many countries and must be considered as serious health risks for large parts of the world population . Simultaneous or combined vaccination against these two diseases would therefore be most advantageous . In order to investigate possible interactions between these vaccines with respect to their tolerability and immunogenicity , we conducted a r and omized prospect i ve study comparing single and simultaneous administration of the two vaccines . Three groups of healthy volunteers , each with 55 persons , were included in the study . All were negative for hepatitis A and hepatitis B markers and had normal serum liver enzyme values . Group I received hepatitis A vaccine ( 720 ELISA units ) into the left deltoid muscle , group II received hepatitis B vaccine ( 20 micrograms ) into the right deltoid muscle and group III received hepatitis A vaccine into the left , and hepatitis B vaccine into the right deltoid muscle . Three doses of the vaccines were administered at 0 , 1 and 6 months . Local and systemic reactions were monitored by means of question naires . Blood sample s for determination of antibody to hepatitis A virus ( anti-HAV ) and antibody to hepatitis B surface antigen ( anti-HBs ) and of serum SGOT and SGPT levels were drawn at months 0 , 1 , 2 , 6 and 7 . There were no serious general and only mild local reactions . The mean serum SGOT and SGPT values remained in the normal range in all groups . The seroconversion rates and mean geometric titres of the anti-HAV and anti-HBs antibodies were similar when the vaccines were administered separately or simultaneously . There were no significant differences between the compared groups . ( ABSTRACT TRUNCATED AT 250 WORDS Healthy Egyptian neonates born to hepatitis B surface antigen (HBsAg)-seronegative mothers were r and omly enrolled in one of three vaccination schedules . A dose of 2.5 micrograms of recombinant HB vaccine was given at birth , two , and six months of age ( group A ) or two , four , and nine months of age ( group B ) . These two groups and a third control group ( group C ) also were given the other routine childhood vaccines ( BCG , DPT , polio , and measles ) . Blood sample s were taken one month after the third vaccine dose in groups A ( seven months of age ) and B ( 10 months of age ) , and a second follow-up blood sample was taken at the age of 18 months for all three groups . Sera were tested for HBsAg and antibody to hepatitis B core antigen , and quantitatively for antibody to hepatitis B surface antigen ( anti-HBs ) using commercial enzyme immunoassay kits . The vaccine was well tolerated and side effects were limited to local soreness , redness , or temporary swelling . Among 590 infants who were followed-up , good ( 51 - 300 mIU anti-HBs/ml ) or excellent ( > 300 mIU/ml ) immune responses occurred in 85 % of the infants in group A and in 96 % in group B. Geometric mean titers of anti-HBs at the first and second follow-up were 306 and 55 mIU/ml in group A , and 1,492 and 147 mIU/ml in group B. The recombinant HB vaccine is safe and immunogenic when given in three doses of 2.5 micrograms in either regimen , but delay of the booster dose of the vaccine until nine months after birth produced a higher immune response A campaign against hepatitis B was launched in 1985 in Latium Region , Italy , aim ed at hospital workers , newborns of HBsAg positive mothers , hemodialysis patients , thalassemics and hemophiliacs . Subsequently , since the beginning of 1987 other at risk categories were included , namely households of HBsAg positive carriers , subjects with accidental exposure to Hepatitis B virus ( HBV ) ( i.e exposure to street syringes ) , health care personnel working outside the hospital setting such as dentists , private clinics and laboratory workers , etc . A protocol was defined by the Regional Epidemiologic Unit ( Osservatorio Epidemiologico Regionale ) in order to evaluate the immunogenicity and safety af the two plasma-derived ( pd ) vaccines registered in Italy , MSD and Pasteur , in field conditions . Subjects belonging to these at risk categories were distributed among 21 hospital based vaccination units , to which the two vaccines were r and omly allocated . Subjects were considered eligible for vaccination if they were HBsAg negative and Anti-HBs negative or Anti-HBs positive at low titer i.e. less than 20 milli-International units per milliliter . Subjects with insulin dependent diabetes , chronic liver disease or known hypersensitivity to vaccine components were also excluded .  Antibody response was checked at six months since the beginning of the vaccination , i.e. after two doses of the MSD and three doses of Pasteur vaccine and expressed in miU/ml by use of Hollinger formula . Pre-vaccination screening , vaccination and post-vaccination anti-HBs testing were offered free of charge . ( ABSTRACT TRUNCATED AT 250 WORDS OBJECTIVE Bacille Calmette-Guerin ( BCG ) is given at 2-months of age ; diphtheria toxoid , tetanus toxoid , whole cell pertussis , oral polio are given at 2 , 3 , 4 months , and hepatitis B virus ( HBV ) vaccine is given at 3 , 4 , 9 months of age . The aim was to evaluate the sero-protection rate of HBV vaccine which has been given at 2 , 3 , and 9 months of age and coincided with BCG vaccine at the first dose . METHODS Hepatitis B virus vaccine was administered to 3 groups of infants at 2 , 3 , 9 months ( n=20 ) , 3 , 4 , 9 months ( n=20 ) concurrently with BCG or other vaccines , and at 0 , 1 , 6 months with no other coinciding another vaccine ( n=20 ) . These 60 infants who were born between June 2001 and September 2001 have been vaccinated at the Akdeniz University School of Medicine , Antalya , Turkey . Antibodies to hepatitis B surface antigen analyzed by enzyme-linked immunosorbent assay . RESULTS The simultaneous administration of BCG and HBV vaccines did not influence the immune response to HBV vaccine . We showed that all 3 schedules can induce the sero-protective levels of antibody concentrations to HBV both one month and one year after the vaccination . CONCLUSION Bacille Calmette-Guerin and HBV vaccinations can be performed at the same time in endemic countries BACKGROUND Due to their impaired immune system , patients with renal insufficiency have a suboptimal response to hepatitis B ( HB ) vaccination and frequent boosters are needed to maintain protection . GlaxoSmithKline Biologicals has developed a HB vaccine containing a new adjuvant system AS04 for use in this immunocompromised patient population . METHODS In an open , r and omized clinical trial conducted in pre-hemodialysis ( documented creatinine clearance < or = 30 mL/min ) and hemodialysis patients , over 15 years of age and naïve for HB , the immunogenicity and safety of single doses of HB-AS04 ( Fendrix , GlaxoSmithKline Biologicals ) were compared to double doses of commercially available HB vaccine ( Engerix , GlaxoSmithKline Biologicals ) administered at 0 , 1 , 2 , and 6 months , and followed-up for 36 months . RESULTS The HB-AS04 vaccine elicited a more rapid onset of protection than the currently licensed vaccine for this particular population , with 74 % versus 52 % of subjects seroprotected at month 3 . After the vaccination course , seroprotection rates increased to 91 % versus 84 % in the HB-AS04 and st and ard vaccine groups , respectively . Differences persisted up to 36 months post-vaccination ( 73 % vs. 52 % , respectively ) . Antibody concentrations were higher following the HB-AS04 vaccine at all post-vaccination time points . During the follow-up , significantly fewer subjects primed with the HB-AS04 vaccine needed a booster dose as a consequence of anti-HBs loss below seroprotective levels ( 11/62 subjects in the HB-AS04 group vs. 22/57 subjects in the st and ard vaccine group , respectively , P = 0.014 ) . The HB-AS04 was more locally reactogenic than the st and ard immunization regimen , with pain at the injection site occurring with 41 % of HB-AS04 doses versus 19 % of st and ard vaccine doses . The occurrence of grade 3 pain was less than 1 % in both groups and all events resolved within the 4-day follow-up period . CONCLUSION The improved immunogenicity profile and clinical ly acceptable reactogenicity of HB-AS04 vaccine are of key importance to provide a more rapid , enhanced , and longer seroprotection to these immunocompromised patients at risk for HB infection As with hepatitis B vaccines , the recently developed hepatitis A vaccine is suitable not only for individual protection , but also for public health control measures . For introduction into routine immunisation programmes , however , hepatitis A vaccine should preferably be combined with other already established vaccines . In particular , a combination of hepatitis A and hepatitis B vaccines would be appropriate . We investigated a new combined hepatitis A/hepatitis B vaccine comparing its tolerability and immunogenicity with that obtained after separate or mixed simultaneous administration of the two components . Three groups of healthy volunteers , each of approximately 50 persons , were included . All were negative for hepatitis A and hepatitis B markers and had normal liver enzyme values . They received hepatitis A ( 720 ELISA units ) and hepatitis B ( 20 micrograms ) vaccines in the deltoid muscle , combined , mixed or separately , according to a 0 , 1 , 6-month schedule . Blood sample s for determination of antibodies to hepatitis A virus ( anti-HAV ) and hepatitis B virus ( anti-HBs ) and of serum alanine aminotransferase ( ALT ) and aspartate aminotransferase ( AST ) levels were drawn at months 0 , 1 , 2 , 6 , and 7 . Local and systemic reactions were monitored by means of question naires . The results of our study demonstrate that the combined hepatitis A and B vaccine is well tolerated and highly immunogenic . The seropositivity and seroprotection rates were 100 % for both antigens in all groups . Surprisingly , anti-HAV and anti-HBs antibody titres after the combined and mixed vaccines were significantly higher compared with the respective monovalent vaccines injected separately Summary To determine the efficacy and safety of hepatitis B vaccine ( Hevac B ) given intradermally , 125 Nigerians ( aged 1 year to 45 years ) , who were negative for hepatitis B virus markers , and r and omised into two groups were vaccinated . Group 1 ( 64 volunteers ) was given 3 monthly doses of 2 µg vaccine mixed with adjuvant subcutaneously ( Institut Pasteur Production-Hevac B ) while group 2 ( 61 volunteers ) received 3 doses of 2 µg non-adjuvated vaccine intradermally given 1 month apart . A month after the third dose 83 per cent of group 1 , 71 per cent of group 2 showed positive response by developing antibody to hepatitis B surface antigen . The levels of antibody were significantly higher in group 1 at each stage of the follow-up period , including a month after a booster vaccination was given . The positive response was maintained in almost all the initial responders for the 24 month duration of the study . No significant side effect was documented in any of the participants . The results suggest that population at risk in developing countries could be protected with small doses of vaccine administered intradermally OBJECTIVE To evaluate protective efficacy of a plasma-derived hepatitis B vaccine during 12 years after vaccination . METHODS A 12-year follow-up of 350 children who participated a r and omized , double blind , placebo-controlled trial in 1982 . RESULTS During the 12 years after vaccination , more vaccinated children had anti-HBs of 10 S/N ratios or more than did the controls . At the 12 years 46.1 % of the vaccinated and 33.9 % of the controls retained anti-HBs levels of S/N ratios > or = 10 ( P < 0.05 ) . However , at 12 years median S/N ratio of anti-HBs of the vaccinated children with detectable anti-HBs was lower than that of the controls ( 15 vs 36 , P < 0.0001 ) . Protective efficacy against HBsAg carriage status at 5 - 10 years after vaccination varied from 83 % to 100 % . At 12 years , 14 chronic HBsAg carriers were identified among the controls , whereas only 1 case was noted in the vaccinated group ( 7.6 % vs 0.6 % , P < 0.01 ) , account for an efficacy of 92 % . CONCLUSIONS Protective efficacy against chronic HBsAg carriage was satisfactory at 12 years after vaccination . No evidence was showed to support a booster of hepatitis B vaccine at this time The reactogenicity and immunogenicity of simultaneous administration of recombinant DNA hepatitis B vaccine with diphtheria and tetanus toxoids ( DT ) and oral poliovirus vaccine ( OPV ) in 111 infants were compared with those of DT and OPV alone in a control group of 21 infants . All subjects received three doses of the vaccine according to one of three different schedules of vaccination . Reactions following simultaneous administration of vaccines were all but absent , with mild pain reported for four out of 111 subjects , compared with one of 21 in the control group . Seroconversion rates of 98 - 100 % and high anti-HBs geometric mean titres ( GMTs ) were observed in all study groups after three doses of hepatitis B vaccine . Significantly higher anti-HBs were seen in Group III , where six months is allowed between the second and the third hepatitis B vaccine doses , compared with Group I and II , where only 1 - 2 months separate the second and third doses . A fourth dose of vaccine was needed in both these groups to obtain anti-HBs levels as high as seen in Group III after three vaccine doses at 3 , 4 and 10 months of age . The immune response to DT and OPV  was similar in the study groups and the control group . It is concluded that a course of 10 micrograms doses of recombinant hepatitis B vaccine given simultaneously with DT and OPV elicits a strong anti-HBs response and does not interfere with the immune response to the other antigens From April 1986 to May 1990 , 265 pupils aged 5 to 9 years in Xian suburbs were studied to evaluate long-term efficacy of plasma-derived hepatitis B vaccine made in China .  Anti-HBs titers in vaccine group reached the highest at twelfth month after the first injection and decreased afterwards . The positive rate of anti-HBs decreased slow , but geometric mean titers of anti-HBs fell sharply . Compared with placebo group , the differences were all significant . The peak anti-HBs titers and the response time positively correlated with the persistence of anti-HBs . 4 years observation showed that protection rate of hepatitis B vaccine  against HBV infection was 80 % . Protection rate was 100 % if HBsAg was only considered A controlled , r and omized trial was conducted in urban areas of Karachi and Lahore with the aim to look for ways to improve the cost-effectiveness of hepatitis B vaccination .  Children under 15 years old ( including neonates ) were selected and screened for immunization by three regimens according to the frequency and doses of the recombinant vaccine used ( Heberbiovac HB , Heber Biotec , Havana ) . Group A received 10 microg at 0 , 1 months ; group B ( control ) received 10 microg at 0 , 1 and 2 months ( st and ard regime ) , and group C received 5 microg at 0 , 1 and 2 months . Antibody levels were titrated 2 months after the last dose . Cut-off for seroprotection and hyperresponse were taken as 10 and 100 IU/L , respectively . Nine hundred and ninety children were included and evaluated after discarding those positive for serological hepatitis virus infection markers . Seroprotection rates were 100 , 99.7 and 99.7 % , and hyperresponse was achieved by 92.7 , 99.4 , and 97 % of the vaccinees in groups A , B , and C , respectively . The same good result was obtained in extreme ages subgroups ( < or = 1 year and > or = 10 years old ) . The 1-year follow up of the children from Karachi showed good persistence of seroprotection ( 98 , 100 , and 99.4 % ) and hyperresponse ( 79.7 , 96.7 , and 87.4 % ) . It is concluded that it is feasible to improve the cost-benefit ratio and compliance of hepatitis B vaccination by means of a two-shots or reduced dose schedule of the vaccine employed in the trial The efficacy of a heat-inactivated hepatitis B virus ( HBV ) vaccine , containing 3 micrograms-HBsAg , was studied among a group of 800 susceptible homosexual men . The trial was conducted r and omized , placebo-controlled and double blind . At the trial end point ( 21.5 months ) the attack-rate for all HBV infections together was 4.8 % among vaccinees and 23.8 % among the placebos ( p less than 0.0001 ) . Four months after the first injection 89 % of the vaccinees had formed anti-HBs and this percentage declined only slightly during the follow-up period . Maximum titers were reached 5 months after the first vaccination . None of the vaccinees who responded to the vaccine with anti-HBs greater than or equal to 1 mIU/ml developed a HBsAg positive infection . The vaccine had no serious side-effects The efficacy of a heat inactivated hepatitis B virus vaccine , containing 3 micrograms hepatitis B surface antigen ( HBsAg ) , was studied in a high risk group of 800 susceptible homosexual men by a r and omised  placebo controlled double blind trial . At the trial end point ( 21.5 months ) , 17 hepatitis B virus infections had occurred in vaccinated subjects ( attack rate 4.8 % ) and 56 in subjects receiving a placebo ( attack rate 23.8 % ) . This reduction in the incidence of hepatitis B virus infections in vaccinated subjects was highly significant ( p less than 0.0001 ) . Two months after the first injection 72.3 % of the vaccinated subjects had formed antibodies against hepatitis B surface antigen , and this percentage increased to 89 % at four months . Maximum anti-HBs titres were reached five months after the first vaccination , the geometric mean titre being 107.6 mIU . Even vaccinated subjects with a low antibody response ( greater than or equal to 1 and less than 10 mIU ) were found to be protected from HBsAg-positive infections . The vaccine had no serious side effects BACKGROUND & AIMS The long-term immunogenicity and efficacy of hepatitis B virus ( HBV ) vaccination remain to be defined . We aim ed to examine the long-term immunogenicity and efficacy of HBV vaccination with 3 different regimens over 18 years of follow-up . METHODS A total of 318 Chinese subjects receiving 3 different regimens of HBV vaccination ( 2-dose recombinant vs. 3-dose recombinant vs. 3-dose plasma-derived vaccines ) without receiving a booster dose were recruited . The HBV serologic markers , including hepatitis B surface antigen ( HBsAg ) , antibody to hepatitis B surface antigen ( anti-HBs ) , and antibody to hepatitis B core antigen ( anti-HBc ) , were determined at yearly follow-up . After 18 years , 88 subjects were still being followed up . RESULTS Compared with subjects receiving the 2-dose regimen , subjects receiving the 3 dose regimens had a significantly higher geometric mean titer of anti-HBs and a higher proportion had anti-HBs titers > or = 10 mIU/mL during the 18 years of follow-up . There were no differences in these 2 parameters between subjects receiving the 3-dose recombinant and subjects receiving the 3-dose plasma-derived vaccines . A total of 88 anamnestic responses were documented in 70 subjects ( 8 with initial anti-HBs titers < 100 mIU/mL at 12 months and 7 with anti-HBs titers < 10 mIU/mL before the anamnestic responses ) . No subject became positive for HBsAg . Three subjects had benign breakthrough HBV infection without leading to chronicity indicated by isolated anti-HBc positivity . CONCLUSIONS There was less long-term immunogenicity associated with the 2-dose regimen when compared with the 3-dose regimens of HBV vaccination . Because of the highly effective anamnestic responses , a booster dose was not necessary at least up to 18 years after the primary vaccination Because of the high prevalence of hepatitis B virus ( HBV ) infection in The Gambia , HBV vaccination has been incorporated into the national exp and ed programme on immunisation . We have assessed the efficacy of the vaccine  against HBV infection and chronic carriage by examining 720 3 - 4-year-old children who had received the vaccine in infancy and 816 who had not received it . The vaccine was 84 % ( 95 % CI 78 - 89 % ) effective against infection and 94 % ( 84 - 98 % ) effective against chronic carriage . Vaccinated infants of mothers positive for hepatitis B surface and e antigens were at greater risk of breakthrough infection and chronic carriage than infants of uninfected mothers . The high vaccine efficacy against the HBV carrier state , the main risk factor for the development of chronic liver disease and liver cancer , offers hope that the prevalence of these diseases may be reduced in the future The study is a r and omized trial using recombinant DNA vaccine to determine whether an intramuscular 10 micrograms dose or intradermal 2 micrograms induces satisfactory anti-HBs levels compared to the st and ard dose of intramuscular 20 micrograms . Participants were 359 healthy medical and nurse students r and omly allocated to one of the three groups : Group I-IM 20 micrograms ; Group II-IM 10 micrograms ; Group III-ID 2 micrograms at 0 , 1 and 6 months . Anti-HBs titres were measured after complete vaccine schedule by ELISA/Pasteur . Baseline variables were similar among groups and side effects were mild after any dose . Vaccines in the IM-10 micrograms group had seroconversion rate and geometric mean titre ( GMT 2344 IU L-1 ) , not significant different from the IM-20 micrograms group ( GMT 4570 IU L-1 ) . On the contrary , 21.4 % of the ID-2 micrograms recipients mount antibody concentration below 10 IU L-1 and GMT of 91 IU L-1 , a statistically significant difference compared with the st and ard schedule IM-20 micrograms ( p < 0.001 ) . A three dose regimen of half dose IM could be considered an appropriate schedule to prevent hepatitis B in young health adults which is of relevance to the expansion of hepatitis B vaccine programme Experimental  hepatitis B immunization trial in newborns was carried out in Burundi . Newborns were r and omly divided into vaccine and control groups . Vaccinated newborns were given two injections of hepatitis B vaccine : one at birth and another 2 months later . A booster dose was given at 12 months of age . Results obtained show that two months after the second dose of HB vaccine , 96.8 % of the vaccinated babies had anti-HBs ; at the age of one year this figure had fallen to 83.8 % . Six months after the booster dose , 95.6 % were anti-HBs positive , with a geometric mean titre of 214 mIU ml-1 . The anti-HBs responses in these infants was compared to those observed in previous studies performed in Senegal in infants ( same protocol ) or in newborns ( 3 dose protocol ) . The anti-HBs responses were lower in terms of mean titre values in neonates who received the two dose protocol than in older children and in neonates who received three doses at one month intervals . Vaccine efficacy was monitored during a two year period in neonates both immunized and nonimmunized . Protective efficacy was found to be 100 % if considering HBsAg positive events and 75 % if considering all HBV events ( HBsAg and /or anti-HBc positive ) The incidence and contributing factors of  cirrhosis  developing in patients with chronic type B hepatitis were assessed prospect ively in 684 clinicopathologically verified patients , of which 509 were HBeAg positive and 175 were anti-HBe positive at entry into the study . During an average follow-up period of 35.3 months , cirrhosis occurred 6 to 64 months after entry in 35 HBeAg-positive and 7 anti-HBe positive patients with a calculated annual incidence of 2.4 and 1.3 % , respectively ( p greater than 0.05 ) . The incidence increased significantly with the increasing age at entry . Patients who had experienced ( a ) hepatic decompensation , ( b ) repeated episodes of severe acute exacerbation ( with alpha-fetoprotein greater than 100 ng per ml and /or bridging hepatic necrosis ) , ( c ) severe acute exacerbation not accompanied by subsequent HBeAg seroconversion and ( d ) hepatitis B virus reactivation ( particularly those with HBeAg reappearance ) were found to develop cirrhosis much more frequently ( p less than 0.001 ) . Contrary to general belief , patients who had hepatitis delta virus superinfection and patients with chronic active hepatitis were not particularly prone to develop cirrhosis . We conclude that in addition to age factor , the extent , severity , duration , frequency and etiology of the hepatic lobular alterations are important factors for the development of cirrhosis in patients with chronic type B hepatitis OBJECTIVE To observe the effectiveness of hepatitis B vaccine nine years after primary immunization . METHODS A r and omized , controlled and double-blinded trial was design ed with 126 children primarily immunized with local produced plasma-derived hepatitis B vaccine nine years ago and 135 placebo-control children aged five to nine years . All the children were followed-up , their blood sample s collected and their disease occurrence examined . Their hepatitis B surface antigen ( HBsAg ) , antibody against hepatitis B core antigen ( anti-HBc ) and antibody against hepatitis B surface antigen ( anti-HBs ) were tested . Causes of lowering in their antibodies were analyzed with multivariate methods . RESULTS During the nine-year follow-up , 4 % to 19 % of the study subjects dropped out . In the ninth year after immunization ( T108 ) , anti-HBs positive rate in the vaccinees and their geometric mean titer ( GMT ) ( 65.3 % and 5.47 , respectively ) were still significantly higher than those in the placebo-controls ( 28.3 % and 1.46 , respectively ) , but significantly lower than those in the 6th year after immunization ( T72 ) . Multivariate analysis for the causes of lowering in the antibody during the 4th , 6th and 9th year after immunization showed that antibody titer in the vaccines first year after immunization ( T12 ) was a crucial factor for the persistence of the antibody , and natural booster might also played a certain role in it . In the T108 , one clinical case of hepatitis B occurred in the placebo control group , but no cases in the vaccinees found , with a protection rate of 81.4 % from HBV infection and 84.6 % from HBsAg positive-coversion , similar to those in the T72 . CONCLUSION The effectiveness of HB vaccine still existed nine years after primary immunization , and no booster dose was needed so far Immunogenicity of four plasma-derived hepatitis B vaccines ( Merck , Sharp and Dohme , Pasteur , Dutch CLB and Korean Cheil-Sugar ) was compared in Thai young adults . After primoimmunization , only the Merck and Pasteur vaccines could achieve greater than 90 % seroconversion ( i.e. anti-HBs greater than or equal to 10 mIU ml-1 ) whereas both the CLB and Korean vaccines needed a fourth dose to achieve this level of seroconversion . The anti-HBs titres of both heat-inactivated vaccines ( CLB and Korean ) were also significantly lower than those of the other two vaccines . We propose that the HBsAg content in both heat-inactivated vaccines should be increased and a booster ( fourth ) dose should be given in order to enhance their immunogenicities One hundred and eight primary school students who had been vaccinated with three doses of a plasma-derived hepatitis B vaccine  were r and omly divided into two groups , to receive a booster dose of either the same vaccine or of a recombinant yeast-derived vaccine . The pre-booster anti-hepatitis B surface antigen ( HBs ) geometric mean titres ( GMT ) were similar in both groups ( 281.8 mIU ml-1 versus 295.1 mIU ml-1 , p greater than 0.5 ) . One month after booster vaccination , all the vaccinees in both groups had a marked elevation in their anti-HBs titres , the anti-HBs GMT in group 1 and group 2 being 19,952.6 and 51,286.1 mIU ml-1 ( p less than 0.05 ) , respectively . In conclusion , the recombinant yeast-derived hepatitis B vaccine was able to elicit an excellent booster response in vaccinees who had originally received a plasma-derived vaccine An inactivated vaccine against hepatitis B was prepared from blood-donor HBs antigen purified on immunoadsorbents . Its safety and efficacy were tested in chimpanzees .  Vaccination was then applied in an attempt to protect patients and staff in a haemodialysis unit . The efficacy of the vaccine in man was assessed by observing humoral and cellular immune reactions and by comparing changes in HBs antigenaemia in vaccinated and non-vaccinated subjects . The results indicate that this vaccine protects against hepatitis B in the circumstances in which it was administered Hepatitis B ( HB ) immunization was introduced as part of the exp and ed programme on immunization ( EPI ) in two provinces in Thail and and evaluated over a four year period . Three doses of HB vaccine were offered to 60,980 newborns at birth , 2 and 6 months of age . The overall coverage for complete HB immunization was 90.4 % . Serosurveys of r and omly selected children under the age of 5 years were undertaken before and at the end of the project . Levels of HBsAg positivity were reduced by 85 % , and there was a corresponding 70 % increase in protective immunity . These findings demonstrate that HB immunization can be successfully integrated into EPI without adverse effect on coverage rates of other antigens , and results in a marked reduction in the rate of chronic carriage of HB virus in preschool age children A prospect i ve study of the immunogenicity , safety and persistence of antibodies induced by the DNA-recombinant anti-hepatitis B vaccine Engerix B was conducted in a risk group as health care workers . 115 health care workers were r and omly allocated into two groups . Immunization was carried out according to a 0 - 1 - 6 month vaccination schedule in one group and to a 0 - 1 - 2 - 12 month schedule in the other group . Results indicate that the DNA-recombinant anti-hepatitis B vaccine is well tolerated and highly immunogenic . Reactogenicity to the vaccine was low in incidence and mild in severity with no significant difference appearing between the study groups
BACKGROUND The benefits and harms of hepatitis B vaccination in persons not previously exposed to hepatitis B infection or with unknown exposure status have not been established .
OBJECTIVES To assess the benefits and harms of hepatitis B vaccination in people not previously exposed to hepatitis B infection or with unknown exposure status .