Protection against hepatitis A by an inactivated vaccine. [A prospective epidemiological investigation on the effect of China-mode attenuated live vaccine against hepatitis A in the population of Liu Zhou]. [Further survey on efficacy of attenuated live hepatitis A vaccines]. Efficacy of virosome hepatitis A vaccine in young children in Nicaragua: randomized placebo-controlled trial. Placebo-controlled efficacy study of hepatitis A vaccine in Valdivia, Chile. A controlled trial of a formalin-inactivated hepatitis A vaccine in healthy children.
To evaluate the safety and efficacy of a new inactivated hepatitis A vaccine.
                Double-blind randomized controlled trial stratified by community.
                Community-based in Thailand.
                A total of 40,119 children, aged 1 to 16 years, attending 148 primary schools: 38,157 (95%) entered surveillance a mean of 138 days after receiving vaccine dose 1; 33,586 (84%) completed the controlled trial of 532 days; and 31,075 (81%) received crossover vaccine and remained under surveillance until day 844.
                Participants received hepatitis A vaccine or control hepatitis B vaccine starting January 7, 1991 (doses in months 0, 1, and 12), and crossed over to the alternate vaccine 18 months later.
                Cases of hepatitis A (symptoms, alanine aminotransferase levels of 45 U/L or higher, and IgM to hepatitis A virus) were identified by evaluating school absences of 2 or more days.
                There were no serious adverse reactions despite administration of more than 109,000 doses of hepatitis A vaccine. Among initially seronegative recipients of two doses of hepatitis A vaccine, the proportion with 20 mIU/mL or more of antibody to hepatitis A virus before and 5 months after a 1-year booster was 94% and 99%, respectively. Of 6976 episodes of illness during the controlled trial, there were 40 cases of hepatitis A; 38 were in the control group. Of the 40 cases, six, all in controls, occurred after the 1-year booster dose. Following two doses of hepatitis A vaccine (days 138 through 386), protective efficacy was 94% (95% confidence interval, 79% to 99%); cumulative efficacy including the postbooster period (days 138 to 532) was 95% (95% confidence interval, 82% to 99%). The two hepatitis A vaccine recipients who had symptomatic infections (257 and 267 days after dose 1) appeared to have been partially protected since their illnesses were brief and associated with only slight increases in alanine aminotransferase.
                Inactivated hepatitis A vaccine is safe; when administered in two doses, it protects against hepatitis A for at least 1 year. An 24-month prospective epidemiological investigation on the results of China-mode Hepatitis A attenuated live vaccine against hepatitis A by random group sampling was carried out. The incidence of case group was 15.91/10(5) (5/31421), the incidence of control group was 95.92/10(5) (30/ 31277) which showed a significant difference. In case group 2081 persons who missed vaccination, there was one person developed hepatitis A, making the incidence 48.05/10(5). In control group 760 persons were vaccinated by mistake and there was no case developed in this sub-population. There were 644 cases of hepatitis A in the external control group, the incidence was 90.14/10(5). Data showed that there was no significant difference among external control group, control group and persons from case group who missed vaccination. Comparing the data from case group and from the above 3 groups, the protective rates were 82.35%, 83.41% and 66.89%. respectively. When conparing the data from persons who had been mistakenly vaccinated in control group, there was no significant difference being noticed. To further survey the protective efficacy of the standard attenuated live hepatitis A vaccines (H(2) strain).
                Randomized and controlled trials were performed in Fucheng county, Hebei province. A total of 12 036 children were assigned into vaccine group (5 551) and control group (6 485) by cluster sampling. The morbidity of hepatitis A was observed and the blood was collected once hepatitis A showed epidemic to detect anti-HAV IgG and IgM.
                During the period of the first 7 months after vaccination, hepatitis A was sporadic, the morbidity of hepatitis A was 0.55/100 000, and only 1 case occurred in the control group and no case in the vaccine group. From January to August 1998, hepatitis A showed epidemic in a township of this county. The morbidities were 0.37% and 6.69% for vaccine group and control group, respectively. The protective efficacy of the vaccine was 94.47%. The ratios of clinical cases to subclinical infections were 1 to 11 and 1 to 1 for vaccine and control groups, respectively (P < 0.05).
                The H(2) strain vaccine has a very good protective efficacy, and obviously decreases the attack rate, new infection rate and clinical cases by HAV infection. Immunization of young children could control hepatitis A virus (HAV) infection, but the efficacy of hepatitis A vaccines in early childhood is unknown. In a randomized, double-blind trial of a single dose of a virosome-formulated, aluminum-free inactivated HAV vaccine in Nicaragua, 274 children (age range, 1.5-6 years) received vaccine or placebo injections; 239 children seronegative for hepatitis A were included in the primary efficacy analysis. HAV infection documented by immunoglobulin M antibodies was the primary end point. Among children seronegative for hepatitis A, infection was diagnosed in 4 children in the vaccine group and 22 children in the placebo group (protective efficacy, 84.6%; 95% confidence interval, 54.7%-96.1%). All infections in children in the vaccine group occurred within 6 weeks. After 6 weeks, protective efficacy was 100% (79.8%-100%). In children in the placebo group, the incidence of HAV infection was 17.6 and that of icteric illness was 1.6 cases/100 person-years. Adverse effects were rare in both children in the vaccine group and children in the placebo group. A single dose of a hepatitis A virosome vaccine is safe and protects young children against HAV infection. A placebo-controlled, double-blind study on the efficacy of a hepatitis A vaccine (SmithKline Beecham Biologicals) was started in a region of Chile in September 1990, using hepatitis B vaccine as control. A total of 260 healthy children, 6-15 years of age, negative for antibody to hepatitis A virus (anti-HAV), antibody to HAV immunoglobulin M (IgM), hepatitis B surface antigen, and antibody to hepatitis B surface and core antigens by ELISA tests within 7 days before vaccination, were randomly assigned to two study groups: 128 children received the vaccine with a yellow label (group 1), and 132 children the vaccine with an orange label (group 2) at months 0, 1 and 6. Blood for serology and transaminase determination was drawn at months 1, 2, 6, 7 and 12. Both vaccines were tolerated equally well and no serious side effects were seen. In group 1 (presumed hepatitis A vaccine group), anti-HAV was detected (20% inhibition was used as the cut-off level) in 122 of 128 children (95.5%) tested at month 1, in 126 of 127 (99.2%) at month 2, in 126 of 127 (99.2%) at month 6 and in 126 of 126 (100%) at month 7. One anti-HAV seroconversion seen at month 1 was associated with presence of anti-HAV IgM and therefore probably represents HAV infection. Geometric mean anti-HAV concentration of the other children was 128, 342, 214 and 2301 mIU/ml at months 1, 2, 6 and 7, respectively.(ABSTRACT TRUNCATED AT 250 WORDS) Although inactivated hepatitis A vaccine is known to be well tolerated and immunogenic in healthy children and adults, its efficacy has yet to be established.
                To evaluate the efficacy of the hepatitis A vaccine in protecting against clinically apparent disease, we conducted a double-blind, placebo-controlled trial in an Hasidic Jewish community in upstate New York that has had recurrent outbreaks of hepatitis A. At the beginning of a summer outbreak, 1037 healthy seronegative children 2 to 16 years of age were randomly assigned to receive one intramuscular injection of a highly purified, formalin-inactivated hepatitis A vaccine or placebo. A case was defined by the presence of typical signs and symptoms, a diagnostic increase in IgM antibody to hepatitis A, and a serum concentration of alanine aminotransferase at least twice the upper limit of normal. Cases occurring greater than or equal to 50 days after the injection were included in the evaluation of efficacy. The children were followed for a mean of 103 days.
                A total of 519 children received vaccine, and 518 received placebo. The vaccine was well tolerated, with no serious adverse reactions. From day 50 after the injection, 25 cases of clinically apparent hepatitis A occurred in the placebo group and none in the vaccine group (P less than 0.001), confirming that the vaccine had 100 percent protective efficacy. Before day 21, seven cases occurred in the vaccine group and three cases in the placebo group. After that time, there were no cases among vaccine recipients and 34 cases among placebo recipients.
                The inactivated purified hepatitis A vaccine that we tested is well tolerated, and a single dose is highly protective against clinically apparent hepatitis A.
Hepatitis A vaccines are effective for pre-exposure prophylaxis of hepatitis A in susceptible individuals. This review demonstrated significant protection for at least two years with the inactivated HAV vaccine and at least five years with the live attenuated HAV vaccine. There was evidence to support the safety of the inactivated hepatitis A vaccine. More high quality evidence is required to determine the safety of live attenuated vaccines.