Comparison of Three Hepatitis B Vaccination Regimens in HIV-Positive Youth
Condition: HIV Infection; Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Engerix-B 20 mcg; Engerix-B 40 mcg; Twinrix 720 EIA HAV Ag plus 20 mcg HBsAg
Intervention description: 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.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 371.0
Sex: All
Minimum age: 12 Years
Maximum age: 24 Years
Healthy volunteers: No
Keywords: Hepatitis B vaccines; HIV-infected adolescents; Hepatitis B infection (negative)

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented HIV+

          -  Age 12 to < 25 years

          -  History of no or one hepatitis B vaccination

          -  Not pregnant.

          -  Females engaging in sexual intercourse must be willing to practice an approved method
             of birth control throughout the completion of the vaccine phase of the study.

        Exclusion Criteria:

          -  History of > 1 hepatitis B vaccination

          -  Serologic evidence of past or present hepatitis B infection: anti-hepatitis B surface
             antigen (HBsAg), HBs-Ag or anti- hepatitis B core antigen (HBcAg)

          -  Previous allergic reaction to hepatitis A or B vaccinations or to yeast, thimerosal or
             aluminum.

          -  Active opportunistic infection or current treatment for known or suspected active
             serious bacterial infection at the pre-entry exam.

        Presence of any known grade >= 3 clinical or laboratory toxicity at the time of pre-entry
        per toxicity tables.

          -  Anticipation of long-term corticosteroid therapy or within 3 months preceding study
             randomization. Use of non-steroidal, anti-inflammatory agents and inhaled or topical
             corticosteroids are allowed.

          -  Receipt of any restricted medicine listed in the protocol section 8.1.3 within 3
             months preceding randomization.

          -  Receipt of immune globulin product or plasma product within 6 months preceding
             randomization

          -  Receipt of licensed blood product or transfusion or any licensed vaccine within 4
             weeks preceding randomization.

          -  Known or suspected diseases of the immune system, other than HIV, or treatment for a
             malignancy within 3 months of randomization.

          -  Other serious, acute or chronic medical or surgical conditions must be approved by the
             protocol chair.