A controlled trial of a formalin-inactivated hepatitis A vaccine in healthy children
| Autor: | Alan Werzberger, Barbara Mensch, Barbara Kuter, Leora Brown, John Lewis, Robert Sitrin, William Miller, Daniel Shouval, Brian Wiens, Gary Calandra, John Ryan, Philip Provost, David Nalin |
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| Rok vydání: | 1992 |
| Předmět: |
Viral Hepatitis Vaccines
medicine.medical_specialty Adolescent Hepatitis A vaccine Placebo Hepatitis A Antibodies law.invention Randomized controlled trial Double-Blind Method law Internal medicine Formaldehyde medicine Humans Hepatitis Antibodies Hepatovirus Child Hepatitis A Vaccines business.industry Hepatitis A Outbreak Alanine Transaminase General Medicine medicine.disease Vaccination Immunoglobulin M Vaccines Inactivated Child Preschool Immunology Viral disease Intramuscular injection business |
| Zdroj: | The New England journal of medicine. 327(7) |
| ISSN: | 0028-4793 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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