HIV Infection Clinical Trial
Official title:
A Randomized, Open-Label Trial of Three Hepatitis B Vaccination Schemas in HIV-Positive Youth
Hepatitis B is a contagious virus that can damage a person's liver. It can be prevented by vaccination, but for many HIV-positive people, the vaccines do not help them achieve adequate protection against this virus. In an attempt to improve response to vaccination and achieve protection from hepatitis B, this trial will compare the immune system response to 3 hepatitis B vaccine regimens in HIV-positive adolescents 12 through 24 years of age.
Suboptimal response to hepatitis B vaccination in HIV+ adults and children has been well
documented in the literature. Given the importance of preventing hepatitis B virus (HBV)
co-infection in HIV+ youth and the poor response rates in this population, this study will
attempt to improve the immediate and long-term sero-response rates by undertaking a
randomized, open-label trial of three hepatitis B vaccination schemas, as follows:
1. standard adult dosing of HBV-only vaccine: Engerix-B 20 mcg at Entry, Week 4 and Week
24
2. increased adult dosing of HBV-only vaccine: Engerix-B 40 mcg at Entry, Week 4 and Week
24
3. standard adult dosing of combined HBV/hepatitis A virus (HAV) vaccine: Twinrix 720
enzyme immunoassay (EIA) HAV Ag plus 20 mcg HBsAg at Entry, Week 4 and Week 24.
This study will also describe the safety of administration of an increased dose of the
hepatitis B vaccine in this population. In general, patients undergoing dialysis who have
received the dosing regimen recommended for immunocompromised individuals have tolerated the
vaccine series well.
Design: This is a stratified, block-randomized, open-label trial of three hepatitis B
vaccination schemas in HIV-infected and HBV-uninfected youth. Once randomized, there will be
a total of 6 study visits in a 72 week period. Vaccination will occur at Entry, Week 4 and
Week 24. Primary sero-response will be evaluated at Week 28 and sustainability of response
will be evaluated at Weeks 48 and 72 for those who achieve a primary antibody response of >=
10 IU/ml. Primary non-responders (antibody response of < 10 IU/ml) will be provided with a
booster vaccine using the increased-dose Engerix-B vaccine at Week 48 and evaluated for
responsiveness at Week 72.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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