Effectiveness of Two Hepatitis B Vaccines in HIV-negative Youths
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate 2 licensed vaccine products (Recombivax and Twinrix) given in a
      two-dose schedule to youth at risk for hepatitis B and HIV infection to evaluate
      immunogenicity of the products in this population, barriers to vaccine delivery, and factors
      which predict a diminished immune response. Since these youths are also potential candidates
      for future HIV vaccine trials, this study will also include preliminary assessment of youths'
      understanding of informed consent forms, and willingness to participate in a vaccine trial
      and return for multiple visits (including blood draws for immunologic assessment).
    

Detailed description: 
      Hepatitis B (HBV) prophylactic immunization has been recommended for at-risk adolescents for
      more than 10 years although universal coverage has not been achieved. Vaccine response in
      healthy adolescents has generally been reported to be excellent. But, data from the study
      Reaching for Excellence in Adolescent Care and Health (REACH) that studied HIV-negative
      adolescents who were at-risk of acquiring Hepatitis B infection through sexual or needle
      sharing behaviors has demonstrated a much lower than expected vaccine response rate in this
      population using standard vaccine dosing. Some data suggest that factors such as gender or
      body mass index might be responsible for the differences in response to the vaccine observed
      in individuals. The reason for the diminished vaccine response in this population is unclear.
      If in fact, Hepatitis B vaccine response is diminished in this population, then efforts to
      determine correlates of response and to improve the response are warranted. The proposed
      trial will evaluate 2 licensed vaccine products given in a two-dose schedule in youth at risk
      for hepatitis B and HIV infection to evaluate immunogenicity of the products in this
      population, barriers to vaccine delivery, and factors which predict a diminished immune
      response.

      Since these youths are also potential candidates for future HIV vaccine trials, participation
      in such trials will require ability to understand and willingness to volunteer for such
      trials, ability to return for multiple vaccinations and blood draws to assess vaccine
      response, and willingness to participate in HIV prevention education. A hepatitis B vaccine
      trial will provide a licensed vaccine to youth in whom the vaccine is indicated and will
      allow preliminary assessment of youth's willingness to participate in a vaccine trial that
      involves blood draws for immunologic assessment.

      Tools that will be necessary for HIV vaccine trials in youth include a youth-friendly
      simplified vaccine trial education component with a required written test for the
      participant, a standardized risk reduction education program, and a computer-assisted
      assessment of youth behaviors. These tools can be finalized and field tested in youth
      participating in the hepatitis B vaccine trial without promoting a false sense of protection
      from HIV. Secondary objectives of this trial will include assessment of a number of ancillary
      tools crucial for future HIV vaccine trials. This Hepatitis B vaccine trial will also serve
      as a HIV vaccine preparedness trial for youth at risk for both Hepatitis B and HIV.

      Design: This is a phase II, randomized, single-blinded trial of two hepatitis B immunization
      regimens in 150 HIV-negative, hepatitis B core antibody, hepatitis B surface antigen and
      surface antibody negative youth. Vaccinations will be given in a two-dose regimen at 0 and
      six months (75 subjects in each arm) and the primary outcome will be seroresponsiveness one
      month after the 6-month dose. Safety and tolerability will also be assessed.
    

Intervention name(s): Recombivax; Twinrix
Intervention type(s): Biological; Biological
Intervention description(s): Participants receive doses of Recombivax at weeks 0 and 24.; Participants receive doses of Twinrix at weeks 0 and 24.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Hepatitis B; HIV vaccine trial