Efficacy of virosome hepatitis A vaccine in young children in Nicaragua: randomized placebo-controlled trial.
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| Abstract |
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.
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| Authors | Orlando Mayorga Pérez, Christian Herzog, Martina Zellmeyer, Arnoldo Loáisiga, Gert Frösner, Matthias Egger |
| Journal | The Journal of infectious diseases (J Infect Dis) Vol. 188 Issue 5 Pg. 671-7 (Sep 01 2003) ISSN: 0022-1899 [Print] United States |
| PMID | 12934183 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't) |
| Chemical References |
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