Comparison of Three Hepatitis B Vaccination Regimens in HIV-Positive Youth
Condition: HIV Infection; Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Engerix-B 20 mcg; Engerix-B 40 mcg; Twinrix 720 EIA HAV Ag plus 20 mcg HBsAg
Intervention type(s): Biological; Biological; Biological
Intervention description(s): A single dose of 1 mL (20 mcg/mL) will be administered in the deltoid muscle at Entry, Weeks 4 and 24.; A single dose of 2 mL (20 mcg/mL) will be administered in the deltoid muscle at Entry, Week 4 and 24.; Arm 3: 720 EIA HAV Ag, 20 mcg HBsAg/ml:
A single dose of 1 mL will be administered in the deltoid muscle.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis B vaccines; HIV-infected adolescents; Hepatitis B infection (negative)