Safety of and Immune Response to a Hepatitis B Virus Vaccine Given With a Booster (CpG7909 ODN) in HIV Infected and HIV Uninfected People

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine the safety of and immune response to a hepatitis B virus vaccine series given with a boosting agent, CpG7909 oligodeoxynucleotides (ODN), in HIV infected and HIV uninfected individuals who previously failed to develop a response to hepatitis B vaccine.

Study hypothesis: Administration of CpG7909 ODN together with recombinant hepatitis B vaccine will result in increased frequency and magnitude of response to vaccine in individuals who have previously failed to mount a response to vaccination, and that in HIV infected subjects with detectable plasma viremia, it will lead to the enhancement of HIV-specific responses.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Vaccines

Criteria

Inclusion Criteria for HIV Infected Participants:

• HIV-1 infection

• If receiving combination antiretroviral therapy (ART), must have been on ART for at least 3 months prior to study entry. Patients who anticipate a change in treatment (either initiating ART or stopping ART) in the next 7 months are not eligible.

• CD4 count of 250 cells/mm3 or greater

• Negative HBsAb, HBsAg, and HBcAb

• Willing to use acceptable forms of contraception while on study treatment and for 24 weeks after study treatment has ended

Inclusion Criteria for HIV Uninfected Participants:

• HIV uninfected

• Negative HBsAb, HBsAg, and HBcAb

• Willing to use acceptable forms of contraception while on study treatment and for 24 weeks after study treatment has ended

Exclusion Criteria for All Participants:

• Cancer. Participants with squamous cell or basal cell skin cancer are not excluded.

• Autoimmune disease

• Immunosuppressive medications. People who use or have used corticosteroid nasal sprays are not excluded. People who have received fewer than 2 weeks of systemic corticosteroids with the last dose over a month prior to study entry are not excluded.

• Any medical or psychiatric condition or occupational responsibilities that may interfere with the study

• Immunomodulator or investigational agent therapy within 30 days prior to study entry

• Allergy/sensitivity to study drugs or their formulations, including thimerosal

• Current drug or alcohol use that, in the opinion of the investigator, would interfere with the study

• Active hepatitis C virus infection, as indicated by serum antibodies to HCV AND detectable HCV RNA in plasma

• Blood clotting abnormalities

• Any other condition that, in the opinion of the investigator, might interfere with the study

• Pregnancy or breastfeeding