Intradermal vaccination against hepatitis B in a group of medical students. Intradermal and intramuscular route for vaccination against hepatitis B. Intradermal hepatitis B vaccination in health care workers. Response rate and experiences from vaccination in clinical practise. Comparative trial of low-dose, intradermal, recombinant- and plasma-derived hepatitis B vaccines. Intradermal hepatitis B vaccination in a large hospital employee population. Low-dose (2 micrograms) hepatitis B vaccination in medical students: comparable immunogenicity for intramuscular and intradermal routes. Efficacy of low dose intradermal hepatitis B vaccine: results of a randomized trial among health care workers. Trials of intradermal hepatitis B vaccines in Gambian children. Clinical trial of the intradermal administration of hepatitis B vaccine produced at the Department of Medical Research, Myanmar. Low-dose intradermal versus intramuscular administration of recombinant hepatitis B vaccine: a comparison of immunogenicity in infants and preschool children. Comparison of higher-dose intradermal hepatitis B vaccination to standard intramuscular vaccination of healthcare workers. Clinical evaluation of low dose intradermally administered hepatitis B vaccine: a comparison of plasma-derived and recombinant yeast-derived vaccines. Intramuscular versus low-dose intradermal hepatitis B vaccine. Assessment by humoral and cellular immune response to hepatitis B surface antigen. Intradermal hepatitis B vaccination in an abbreviated schedule. High Seroprotection Rate Induced by Intradermal Administration of a Recombinant Hepatitis B Vaccine in Young Healthy Adults: Comparison with Standard Intramuscular Vaccination Efficacy of low dose intra-dermal hepatitis B vaccination schedule. Immunogenicity of low dose intradermal hepatitis B vaccine and its comparison with standard dose intramuscular vaccination. Immunogenicity of low-dose intramuscular and intradermal vaccination with recombinant hepatitis B vaccine. A randomized double-blind clinical trial of a mammalian cell-derived recombinant DNA hepatitis B vaccine compared with a plasma-derived vaccine. Intradermal, subcutaneous or intramuscular administration of hepatitis B vaccine: side effects and antibody response. Comparison of three different schedules of vaccination against hepatitis B in health care workers. Comparison of intradermal and intramuscular hepatitis B vaccination in university students.
A prospect i ve study of a low-dose ( one-tenth ) intradermal regimen using recombinant hepatitis B vaccine was undertaken during two consecutive years in 4th-year medical students . Eighty-one per cent of the vaccinees ( 123/152 ) sero-converted with anti-HBs levels of greater than 10 IU/l . The lower titre of hepatitis B surface antibodies compared with published studies on intramuscular immunisation , together with a sero-conversion rate of only 81 % , makes the intradermal method , in our opinion , a suboptimal form of hepatitis B immunisation A recombinant hepatitis B vaccine was administered to high-risk hospital personnel by intramuscular ( 20 micrograms ) or intradermal ( 2 micrograms ) injections for the primary immunization ( n = 69 ) with three doses and booster immunization ( n = 51 ) with one dose . Basic vaccination performed intramuscularly gave rise to significantly higher seroconversion levels ( 97.2 % versus 78.1 % ) and geometric mean titres of antibody ( 1649 versus 126 IUl-1 ) as compared with the intradermal route . Intradermal administration did not boost antibody titres in patients previously vaccinated intradermally . Adverse reactions were not serious or severe . The intramuscular route is recommended as the procedure of choice when vaccinating against hepatitis Health care workers at risk for hepatitis B virus infection are recommended for vaccination . Low-dose intradermal ( i.d . ) administration of vaccine has been suggested as a less expensive alternative to intramuscular ( i.m . ) inoculation . To evaluate the i.d . vaccination route , health care workers were included in a prospect i ve study . The subjects were vaccinated with 0.1 ml (= 2 microg ) recombinant vaccine ( Engerix B , SmithKline Beecham ) i.d . at 0 , 1 and 6 months . Two months after the third vaccination , measurement of the anti-HBs level was conducted . An anti-HBs level > or = 10 IU/l was considered protective . Those with an anti-HBs level < 10 IU/l were given a fourth dose with new serological control after another 2 months . The results are based on the 1406 subjects that it was possible to evaluate . The seroconversion rate to protective anti-HBs level after 3 doses was 68 % and after 3 or 4 doses 89 % . Factors associated with a lower response rate were increasing age ( p<0.05 ) and smoking ( p<0.001 ) . Sex or body mass index had no influence on the results . Vaccination technique seems to be of utmost importance when the i.d . route is used . Well instructed and experienced nurses are required and quality control with follow-up of overall seroconversion rate within each centre is needed The immunogenicity and reactogenicity of low-dose , recombinant DNA and plasma-derived hepatitis B vaccines were investigated in a prospect i ve , double-blind , r and omized , controlled trial . Volunteers ( 153 ) received either recombinant vaccine , 10 micrograms in 1 ml intramuscularly ; plasma-derived vaccine , 2 micrograms in 0.1 ml intradermally or recombinant vaccine , 1 microgram in 0.1 ml intradermally at 0 , 30 , and 150 days . Peak geometric mean concentrations of antibody to hepatitis B surface antigen at day 200 were 1094 , 387 , and 43 mIU/ml , respectively . By day 360 , these concentrations had fallen to 346 , 124 , and 19 mIU/ml , respectively ( P less than .05 between groups both date s ) . Number of subjects with antibody greater than or equal to 10 mIU/ml at day 200 was similar between the 10-micrograms recombinant and 2-micrograms plasma-derived groups ( 94 % vs. 90 % ) , while only 78 % of the 1-microgram recombinant group had protective concentrations of antibodies ( P less than .05 ) . Erythema and in duration occurred in most subjects in both intradermal groups , while pain was prominent at the intramuscular site especially after the second dose . Thus , plasma-derived vaccine , 2 micrograms in 0.1 ml intradermally , appears to be an acceptable cost-saving method for hepatitis B immunization , while recombinant-derived vaccine , 1 microgram in 0.1 ml intradermally , produced less satisfactory results The intradermal route of hepatitis B vaccine administration has been tested in several clinical trials and has produced various degrees of immunogenicity , but usually among small groups of participants . To assess more adequately the immunogenicity of hepatitis B vaccine using the intradermal route , the Centers for Disease Control conducted a clinical trial among 425 well health-care workers in a hospital setting . Participants were r and omly assigned to one of two treatment groups : those receiving a 20 micrograms intramuscular injection , and those receiving a 2 micrograms intradermal injection . Participants received the plasma-derived hepatitis B vaccine by the st and ard schedule at 0 , 1 and 6 months , and serum sample s were collected at 3 , 8 , 12 and 24 months after the first dose . Antibody response rates ( anti-HBs titre greater than or equal to 10 sample ratio units by radioimmunoassay ) for the intradermal vaccination group were consistently lower than those for the intramuscular vaccination group at each testing interval . The differences were greatest for the 3-month test and decreased over time . Geometric mean titres for anti-HBs for the intradermal group were significantly lower than those for the intramuscular group at the 8-month test point . In addition to inoculation route , factors of gender , smoking and age were found to have significant effects on immune response . The results suggest that intradermal vaccination with hepatitis B vaccine may be appropriate under certain conditions and for certain population subgroups In a r and omized controlled trial , 165 healthy medical students were immunized either by the intramuscular route ( IM group ) or by the intradermal route ( ID group ) with low-dose ( 2 micrograms ) plasma hepatitis B vaccine ( HB-VAX ) at months 0 , 1 , 2 , and 6 . At month 7 , protective immunity ( anti-HBs greater than 10 IU/l ) was observed in 90 % ( 95 % confidence interval [ Cl ] : 84 - 97 ) of group IM and in 94 % ( 95 % Cl : 89 - 99 ) of group ID ; also geometric mean titres ( IM : 533 IU/l ; ID:541 IU/l ) were very similar at month 7 . Sixty-six ( IM : 29 ; ID : 37 ) of 107 vaccinees with anti-HBs less than 1,000 IU/l at month 7 received a 2 micrograms booster injection at month 12 . Long-term immunity ( anti-HBs greater than 1,000 IU/l ) was finally observed in 58 % for group IM and 66 % for group ID . For low-dose hepatitis B immunization , which reduces costs to about 16 % , the IM route is to be preferred in young healthy individuals in view of an ease of administration , avoidance of long-term local side effects , and the known protective immunity of intramuscularly induced anti-HBs antibodies BACKGROUND Hepatitis B virus ( HBV ) infection is an occupational health hazard among the healthcare workers .  Vaccination against HBV has been established to be the most effective preventive strategy . The present study was design ed to assess the efficacy of low dose intradermal HBV vaccine among the nursing staff in a tertiary care hospital setting . PATIENTS AND METHODS Staff nurses working in our hospital were included in the study as vaccine recipients . Each staff nurse was tested for HBsAg and anti-HBs ( commercial ELISA ) . Those who tested negative for both the above markers were r and omized to receive either three doses of intramuscular ( i.m . ) HBV vaccine ( 20 micrograms m each dose ) at 0 , 1 and 6 month interval or three doses of intradermal HBV vaccine ( 2 micrograms m each dose ) at similar intervals . Each vaccine recipient was tested for the presence of anti HBs ( commercial ELISA ) at the end of 1 month and 1 year after the last dose of the vaccine . The anti-HBs titres were also estimated simultaneously in them . RESULTS Out of 153 staff nurses screened , 19 were either positive for HBsAg ( n = 1 ) or anti HBs ( n = 18 ) . 96(72 % ) of the remaining 134 nurses agreed to receive HBV vaccine ( i.m.--48 , intradermal--48 ) . At the end of 1 month after last dose of the vaccine , all vaccinees in both the group tested positive for anti-HBs . However the anti-HBs titres at 1 month were significantly higher among intramuscular vaccinees than the nurses receiving the vaccine through intra-dermal route ( 253 + /- 127.7 mIU/ml vs 151.3 + /- 92.8 mIU/ml , P < 0.001 ) . Eighty four ( 85.5 % ) of these 96 vaccine recipient were available for evaluation of anti-HBs titre at the end of 1 year after the last dose of vaccine ( 1 M group = 40 , Intradermal group = 44 ) . All the nurses continued to be positive for anti-HBs at the end of 1 year but the anti HBs-titre among i.m . vaccine recipient continued to remain at a significantly higher level than the similar titre among the intradermal vaccine recipients ( 256.4 + /- 124.7 mIU/ml vs 121.6 + /- 122.4 mIU/ml p < 0.001 ) . CONCLUSION Intradermal route for HBV vaccine had similar immunogenic efficacy as the conventional intramuscular route , but the dose required in the former route is one tenth of the intramuscular route . Therefore intradermal route may reduce the cost of HBV vaccine markedly Three trials of intradermal hepatitis B virus ( HBV ) vaccines were made in Gambian children . In the first trial HBV vaccine ( 1 microgram ) was given to neonates in the same syringe with BCG followed by two further does of 1.0 microgram of intradermal HBV vaccine . The trial was a failure , for 19 of 32 subjects had an HBV surface antibody response of less than 10 m.i.u./ml . In the second trial in young children two different regimes were used : two doses of 2 micrograms HBV vaccine were given intradermally after a 20 micrograms intramuscular dose or three doses of 2 micrograms were given intradermally . In both cases geometric mean antibody responses were significantly lower than in the control group who were given 20 micrograms HBV intramuscularly followed by two 10 micrograms doses intramuscularly . Vaccine failures , defined as the presence of HBV surface antigen or core antibody or absence of surface antibody , were also significantly higher in the intradermal groups . In the third trial 4 micrograms of vaccine were given intradermally to 20 young children with a multiple orifice head fired by a jet gun : all had a good HBV surface antibody response of greater than 100 m.i.u./ml of serum A total of 280 apparently healthy volunteers were screened for hepatitis B ( HB ) markers out of which 49 subjects ( 17.5 % ) were positive for HB surface antigen ( HBsAg ) and 82 ( 29.3 % ) were positive for antibody to HBsAg ( anti-HBs ) . Three doses of DMR-HB vaccine , 0.15 ml per dose were administered to 95 subjects , who were serologically negative for both HB markers . The vaccination was given by the intradermal route on the flexor surface of the left forearm , at 1 month intervals according to the 0 , 1 and 2 months schedule . The subjects were carefully monitored to record any adverse reaction of the vaccine . Blood specimen was collected from each subject , 1 month after the second and third vaccinations , to determine the anti-HBs antibody response to the vaccine . The study results showed that local pain was the only side effect noted and protective antibodies ( anti-HBs ) were detected in 69 ( 72.6 % ) of the vaccinees after the second dose of the vaccine and 89 ( 93.6 % ) after the third dose of the vaccine . Thus the intradermal route , which would require approximately one-seventh of the st and ard dose , would be suitable for use in certain groups such as high risk adults , when the cost of the vaccine is the inhibiting factor for routine or mass vaccination Two hundred infants and two hundred preschool children were r and omly assigned to receive either 10 micrograms of recombinant hepatitis B vaccine ( GenHevac B ) intramuscularly ( i.m . ) or 2 micrograms intradermally ( ID ) in the deltoid region at 0 , 1 and 6 months . Antibody to hepatitis B surface antigen ( anti-HBs ) was tested eight weeks after the third vaccine dose . St and ard dose i.m . and low-dose ID administration of recombinant hepatitis B vaccine produced comparable rates of anti-HBs equal to or higher than 10 mIU ml-1 in infants ( 98 % and 94 % , respectively ) and preschool children ( 98 % and 100 % , respectively ) . Although i.m . vaccination produced higher anti-HBs concentrations than ID vaccination both in infants ( geometric mean titre-GMT , 935 versus 621 mIU ml-1 ) and preschool children ( GMT , 1393 versus 804 mIU ml-1 ) , the differences were not statistically significant ( p > 0.05 ) . The preschool children tended to have higher anti-HBs concentrations than the infants . No clinical ly serious adverse effects were observed in both vaccine groups ; however , in duration and hyperpigmentation at the injection site were more often seen in the study population that was vaccinated intradermally . We conclude that intradermal administration of 2 micrograms recombinant hepatitis B vaccine is safe and effective in infants and preschool children , and may be an acceptable , less expensive alternative to full-dose i.m . vaccination for mass immunization , especially in developing countries OBJECTIVE To compare the immunogenicity of hepatitis B vaccine administered via intradermal ( ID ) versus intramuscular ( IM ) route . METHODS Subjects chose either to specify the route of immunization or to undergo r and om allocation to vaccination by the ID ( 0.15 mL ) or the IM ( 1.0 mL ) route . Yeast-derived recombinant hepatitis B vaccine was given at 0 , 30 , and 180 days . Hepatitis B surface antibody ( HBsAb ) and hepatitis B core antibody ( HBcAb ) were measured by microparticle enzyme immunoassay . RESULTS 763 subjects were enrolled . Baseline screening identified 65 subjects ( 8 % ) who were positive for HBsAb or HBcAb .  Vaccination was completed by 590 ( 85 % ) of 698 enrollees ( 370 ID , 220 IM ) . Seroconversion rates ( geometric mean titers [GMT]>0 IU/mL HBsAb ) for those vaccinated ID were 99 % and 96 % for screening at 9 months and 1 year post-vaccination , respectively ; subjects vaccinated intramuscularly had similar rates of 95 % and 96 % . Seropositivity rates ( GMT > or = 10 IU/mL HBsAb ) showed a similar pattern , with 95 % , 92 % , and 73 % at 9 months and 1 and 2 years , respectively , for those vaccinated ID , and 94 % , 93 % , and 81 % for those having IM vaccination . GMT for HBsAb was significantly higher for individuals vaccinated IM than for those vaccinated ID ( P<.0001 ) . The GMT ratio for the IM and ID routes decreased over time , being 9.3 at 9 months , 7.8 at 1 year , and 5.9 at 2 years . An unanticipated side effect of intradermal vaccination was skin discoloration at injection sites , which persisted for at least 2 years postvaccination . Two thirds ( 112/166 ) of respondents reported that they would have selected the ID route despite the discoloration . CONCLUSIONS Higher-dose ID vaccination ( 3 vs 1 microg per injection ) uses one sixth of the dose required for st and ard IM vaccination . It is a cost-effective way to vaccinate population s against hepatitis B virus , but the long-term efficacy of the ID route must still be investigated A study of the safety and immunogenicity of plasma-derived and yeast-derived recombinant hepatitis B vaccines administered by the intradermal route is reported . Three groups of medical students were inoculated intradermally at 0 , 1 and 6 months with 2 micrograms of vaccine .  Group 1 ( n = 24 ) were administered plasma-derived vaccine ( Green Cross HB-vaccine ) , group 2 ( n =  21 ) yeast-derived recombinant vaccine ( Engerix B ) , and group 3 ( n =  13  )  two doses of plasma-derived vaccine with a third dose of yeast-derived vaccine . One month after administration of the third dose of vaccine , seroconversion rates in each of the three groups were 83 , 100 and 92 % , respectively , with anti-HBs geometric mean titres ( GMT ) of 329 IU l-1 , 1390 IU l-1 and 1061 IU l-1 . Although differences in seroconversion rates were not statistically significant , the GMT in group 1 was significantly lower than that in group 2 ( p less than 0.01 ) and group 3 ( p less than 0.05 ) . The results presented show that intradermal administration of plasma-derived or yeast-derived vaccine , or a combination of the two , can provoke an effective immunogenic response to hepatitis B virus at approximately 10 % of the cost of intramuscular vaccination . In this study administration of yeast-derived vaccine yielded better results than plasma-derived vaccine when administered by the intradermal route The capacity of hepatitis B surface antigen ( HBsAg ) vaccine ( which was administered by the conventional intramuscular route or as a one-tenth dose by the intradermal route ) to elicit an antibody or delayed-type hypersensitivity response to HBsAg was compared for 40 paired healthy subjects , 20 per group , of whom 38 completed the vaccination protocol . The 40 subjects were allocated at r and om to receive three doses of 20 micrograms of vaccine intramuscularly , or three doses of 2 micrograms of vaccine intradermally .  Titres of antibody to HBsAg ( anti-HBs ) were expressed in a radioimmunoassay by sample ratio ( signal-to-noise ) units ( SRU ) . The maximal mean levels of anti-HBs ( maximal one month after the third injection ) were 108 SRU for the intramuscular group and 51 SRU for the intradermal group , and the levels for the intramuscular group were significantly higher at all other time-points . The levels of anti-HBs declined equally with time over 18 months in both groups . More subjects in the intramuscular group ( 17 of 19 subjects ) showed a response to anti-HBs than in the intradermal group ( 14 of 19 subjects ) . Non-respondents in either group responded with similar frequency to further intramuscularly-administered vaccine . The frequency of delayed-type hypersensitivity to HBsAg was similar for both groups . Thus , immunization with HBsAg , when administered intradermally in a dose that is one-tenth of that recommended for intramuscular administration , induces an immune response in healthy subjects . However , since the level of antibody is lower than that after intramuscular injection , revaccination might be needed at more frequent intervals Two low-dose intradermal regimens for hepatitis B vaccination were compared with the st and ard 1 ml dose administered intramuscularly to healthy , 22 - 42 year old individuals . All regimens were administered in an abbreviated time schedule . Nineteen individuals ( ID-1 group ) received three 0.1 ml ( 2 micrograms ) doses intradermally at times 0 , 1 month and 4 months . Twenty-four individuals ( ID-2 group ) received two injections of 0.2 ml ( 4 micrograms ) each intradermally at time 0 and one 0.1 ml ( 2 micrograms ) injection 4 months later . Twenty individuals ( IM group ) received the recommended three 1.0 ml ( 20 micrograms ) doses intramuscularly at times 0 , 1 month , and 4 months . No significant adverse reactions were attributable to the intradermal administration of vaccine although the majority of vaccinees developed small areas of in duration and hyperpigmentation at the injection site that persisted for several months . One month following the last injection , all vaccinees had developed anti-HBsAg antibodies . One hundred percent of ID-1 and IM vaccinees and 95 % of ID-2 vaccinees had protective levels of antibody ( greater than or equal to 10 mIU ml-1 ) . The geometric mean titre ( GMT ) for the IM group ( 2692 mIU ml-1 ) was somewhat higher than for the ID-1 ( 1230 mIU ml-1 ) and the ID-2 ( 851 mlU ml-1 ) groups , but the differences were not statistically significant . Since anti-HBs antibodies are thought to confer protection against hepatitis B , these results suggest that a shortened regimen of intradermal vaccine may be effective in healthy adults . However , no efficacy study has yet been done with intradermal hepatitis B vaccine Intradermal ( ID ) vaccination has been proposed as a cost-saving alternative for administration of Hepatitis B ( HB ) vaccine to implement of mass vaccination of high-risk groups , particularly in developing countries . Therefore , the effectiveness of ID vaccination needs to be evaluated and verified in different ethnic background s. The present study is a r and omized trail using a recombinant vaccine ( Heberbiovac ) to compare immunogenecity and safety of an intradermal low-dose ( 4 μg ) with st and ard dose ( 20 μg ) of intramuscular ( IM ) vaccination in healthy Iranian population . Participants were 143 healthy Iranian medical and nursing students r and omly allocated to ID or IM vaccination group . The vaccine was inoculated at 0 , 1 and 6months intervals . Serum sample s were collected 1month after the last vaccination and the anti-HBs response was determined using ELISA . The overall seroprotection rate ( anti-HBs level ≥ 10IU/L ) was 97.3 % for ID vaccination group , which was not different from that of IM vaccination group (98.55%)(p= 0.99 ) . Similarly , geometric mean titers ( GMT ) of anti-HBs were not significantly different between ID ( 1164.1IU/L ) and IM ( 1071.8IU/L ) vaccination groups ( p= 0.4 ) . There was no significant difference in seroprotection rate and GMT of anti-HBs between sexes . Although in duration and hyperpigmentation at the site of injection were more frequently observed in ID vaccination group , no other clinical ly adverse effects were observed in both vaccination groups . We conclude that the ID route , which would require one-fifth of the st and ard dose , would be suitable for use in certain groups such as high-risk adults when the cost of vaccine is the inhibiting factor for mass vaccination Efficacy of low-dose , intra-dermal hepatitis B vaccination was assessed among sixty-one doctors and paramedical staff of Ch and ka Medical College Hospital , Larkana . Subjects were r and omly divided into two groups . Group-A ( n = 25 ) received 20 micrograms of purified Hepatitis B Surface Antigen ( Euvax B , LG Chemicals ) by i.m . injection in the deltoid by 0 , 1 and 6 schedule while group B ( n = 36 ) received 5 micrograms intra-dermally by same schedule . The mean value of HBsAb titers checked 4 weeks after the last dose in group A were 158.6 + /- 51.8 mlU/ml and that in Group B were 68.2 + /- 26.6 mlU/ml ( p < 0.0001 ; 95 % C.I. 69.2 and 111.5 ) . Number of subjects attaining the protective titers of 10 mlU/ml in group A was 95.7 % and that in group B was 90.9 % ( p = 0.5 ) . We conclude that 5 micrograms intradermal hepatitis B vaccination is effective OBJECTIVE A prospect i ve study was carried out in the well baby and immunization clinics of tertiary care hospital to compare the immunogenicity of low dose hepatitis B vaccine ( HBV ) given intradermally versus st and ard dose given intramuscularly . METHODS One hundred ninety six term , healthy , Australia antigen negative and exclusively breast fed babies were allocated into two groups in a simple r and omized manner . In group I , hepatitis B vaccine was given in low dose ( 2 mcg ) by intradermal route whereas in group II it was administered in st and ard dose ( 10 mcg ) by intramuscular route . Diphtheria , pertussis , tetanus ( DPT ) and oral polio vaccine ( OPV ) were co-administered with HBV in both the groups at 6 , 10 and 14 weeks of age at different sites . One hundred seventy seven infants could be regularly followed up and tested for anti-HBs titres by third generation ELISA test using mono-ELISA anti-HBs 3.0 kits . Geometric mean titres of anti-HBs were estimated in each group and compared . Student 's t-test was used for statistical analysis . RESULTS Seroprotective anti-HBs titres ( titre greater than 10 mIU/mL ) were achieved in 87 of 88 ( 98.8 percent ) children having received intramuscular doses as compared to 82 of 89 ( 92.1 percent ) children in the intradermal group . The geometric mean titres of the intradermal group were 92.71 mIU/mL ( 95 percent C.I. 68.85 - 124.85 ) , significantly lower than 331.66 mIU/mL ( 95 percent C.I. 245.12 - 448.78 ) , noticed in the intramuscular group . There were no significant adverse reactions in both the groups . Hepatitis B vaccine is immunogenic when co-administered with DPT and OPV vaccine . The intradermal hepatitis B administration is less effective with lower immunogenicity than the intramuscular vaccination 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 Eight hundred volunteers from heath care and emergency fields participated in a r and omized double-blind clinical trial of a new experimental mammalian cell-derived recombinant DNA hepatitis B vaccine ( Betagen ) compared with a licensed plasma-derived vaccine ( Heptavax-B ) . Vaccine injections ( 20 micrograms ) were administered intramuscularly at 0 , 1 , and 6 months , and sera were tested at 0 , 1 , 2 , 3 , 6 , 7 , and 12 months for hepatitis B surface antigen , antibody to hepatitis B surface antigen , and antibody to hepatitis B core antigen . Data from 745 vaccinees ( 93.1 % ) , analyzed at the 7th month of follow-up , showed no significant difference in the seroconversion rates for Betagen ( 94.4 % ) vs Heptavax-B ( 97.3 % ) , but the geometric mean titer of antibody was significantly higher for Heptavax-B ( 11 833 mIU/L ) than for Betagen ( 4628 mIU/mL ) . The antibody response of Betagen was significantly and independently related to age and sex , while that of Heptavax-B was related to age only . Reported side effects from both vaccines were minor and mild , with approximately one fourth of all vaccinees reporting at least one side effect . Vaccinees , who had a protective level of antibody at the 7th month , were tested for antibodies at the 12th month . Of those in the Betagen-vaccinated group and those in the Heptavax-B-vaccinated group , 99.0 % and 100 % , respectively , were still protected . There was a proportionately larger decline in the geometric mean titers of antibody to hepatitis B surface antigen for Heptavax-B than for Betagen The immune response after vaccination with a plasma-derived hepatitis B unit vaccine ( MSD ) administered intradermally or subcutaneously in 2 microgram doses was compared to the recommended 20 microgram dose administered intramuscularly . The trial was performed in 58 healthy volunteers 20 - 43 ( mean 30 ) years old . No statistically significant difference in seroconversion rate was observed when the intradermal ( i.d . ) ( 2 micrograms ) and intramuscular ( i.m . ) ( 20 micrograms ) routes were compared ( 100 % and 96 % seroconversion , respectively ) . The 2 microgram dose administered subcutaneously gave a seroconversion rate of only 63 % . The intradermal and i.m . routes also gave significantly higher mean titers of anti-HBs than the subcutaneous route ( p less than 0.005 ) . No severe reactions occurred and local reactions were seen almost exclusively in those vaccinated intradermally . These reactions included mainly discoloration , itching and nodule formation at the site of injection . The intradermal route ought to be considered for administration of hepatitis B vaccine since the dosage can be reduced to 1/10 without affecting the antibody response . Correct intradermal deposition of the vaccine is , however , crucial for an adequate immune response . This is probably the main disadvantage if large-scale vaccination programs should be carried out in developing countries using i.d . immunization Health care workers ( HCW ) are a group at risk for hepatitis B virus ( HBV ) infection ; as a result , vaccination is recommended . However , elevated cost of the vaccination schedule is one of the limiting factors to this approach . Our aim in this study was to evaluate alternative schedules for vaccination against hepatitis B , in order to obtain safe immunization with reduced costs . We studied 300 HCW , r and omized to be su bmi tted to one of three vaccination schedules against hepatitis B : Group A -- three doses of 20 micrograms i.m  . ( n = 103 ) ; Group B -- first dose i.d .  ( 2 micrograms ) , second and third doses i.m . ( 20 micrograms ) ( n = 97 ) ; Group C -- first and second doses i.d . ( 2 micrograms ) , third dose i.m . ( 20 micrograms ) ( n = 100 ) . All individuals received recombinant vaccine at 0 , 1 and 6 months . After the first dose , there was no difference among the three schedules , either in terms of anamnestic response or in seroconversion rate . After the second dose , there was statistical difference among the three schedules ( A > B > C ) , in terms of seroconversion rates . After the third dose , seroconversion rates were 92.2 % in Group A and 92.8 % in group B ; geometric mean titers ( GMT ) in Group B ( 789.6 UI l-1 ) were similar to group A ( 1248.0 UI l-1 ) . Group C presented a seroconversion rate of 78 % and a GMT of 323.0 UI l-1 , both statistically inferior to other schedules . We concluded that the schedule applied in Group B had similar results when compared to schedule A , with estimated savings of 30 % in vaccine costs . ( ABSTRACT TRUNCATED AT 250 WORDS Antibody levels following intradermal and intramuscular hepatitis B vaccination were compared in a group of university students matched for age and sex . Intradermal vaccination gave satisfactory antibody levels in females , but much lower levels than by the intramuscular route and an unacceptable failure rate in men . The cost implication s of introducing a selective vaccination policy in health care workers are discussed
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