Effectiveness of Two Hepatitis B Vaccines in HIV-negative Youths
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Recombivax; Twinrix
Intervention description: Participants receive doses of Recombivax at weeks 0 and 24.; Participants receive doses of Twinrix at weeks 0 and 24.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 123.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatitis B; HIV vaccine trial

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV negative youth age 12-17 years (No serologic evidence of HIV infection).

          -  Negative hepatitis B serology. (No serologic evidence of hepatitis B surface antigen
             (HBSAg), hepatitis B surface antibody (HBsAb or anti-HBs) and hepatitis B core
             antibody (HBcAb or anti-HBc)).

          -  Either no prior hepatitis B immunizations or unknown or incomplete hepatitis B
             immunization status.

          -  Willing to participate in HIV risk-reduction counseling and computer assisted
             measurement of behaviors.

          -  Parent or legal guardian willing to provide written permission

          -  Females of childbearing potential must have a negative pregnancy test at screening and
             should agree to avoid pregnancy through the end of the vaccine phase of the study.
             Females who are engaging in sexual intercourse must be willing to practice a reliable
             method of birth control through the end of the vaccine-phase of the study
             (approximately 6 months). The decision of what is "reliable" is at the discretion of
             the site investigator.

        Exclusion Criteria:

          -  Presence of any serious illness requiring treatment with systemic medications,
             excluding treatment for asthma.

          -  Previous allergic reaction to any vaccines or to constituents of these vaccines
             (yeast, thimerosal or aluminum)

          -  Pregnancy

          -  Current immunomodulator therapy

          -  Receipt of immunosuppressor therapy (more than 10 mg/day of prednisone or equivalent
             for >1 week) in the 6 months preceding entry or anticipated long-term corticosteroid
             therapy in the above dose and duration. Short term (< 7 days) steroid use for the
             treatment of asthma is not an exclusion.

          -  Receipt of any vaccine within 2 weeks preceding study entry.