A Study to Compare the Efficacy of Hepatitis A Vaccine and Immune Globulin When Given After Exposure to Hepatitis A

Summary

Immune globulin is effective about 85% of the time in preventing hepatitis A in people who have been exposed, if it is given within 14 days of exposure. Several lines of evidence suggest that hepatitis A vaccine might also be effective in this setting, and vaccine has the advantage of providing long term protection. In this study, we compare how well immune globulin and hepatitis A vaccine work in preventing clinical hepatitis A in household contacts of persons with the disease. The study's hypothesis is that the the proportion of exposed household contacts who receive hepatitis A vaccine within 14 days of exposure and develop hepatitis A disease will be similar to the proportion of exposure household contacts who receive immune globulin within 14 days of exposure and develop hepatitis A disease.

Timeline

Start

2003-09

Primary completion

—

Completion

2005-05

Publications

• Victor JC, Monto AS, Surdina TY, Suleimenova SZ, Vaughan G, Nainan OV, Favorov MO, Margolis HS, Bell BP. Hepatitis A vaccine versus immune globulin for postexposure prophylaxis. N Engl J Med. 2007 Oct 25;357(17):1685-94. doi: 10.1056/NEJMoa070546. Epub 2007 Oct 18.

Drugs

Indications