safety of and immune response to a hepatitis b virus vaccine given with a booster (cpg7909 odn) in hiv infected and hiv uninfected people

Conditions: HIV Infections; Hepatitis B

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.

as hiv disease progresses in hiv infected people, their immune responses to infectious and other foreign invaders becomes weaker; in particular, the cellular (t-cell) immune response is particularly affected by hiv. a boosting agent called cpg7909 odn may be an ideal adjuvant for vaccines given to hiv infected people, because it may help elicit an increased cd8 t-cell response. this study will evaluate the safety of and immune response to a hepatitis b virus vaccine series given with cpg7909 odn in hiv infected and uninfected people. there will be three groups in this study; participants will be stratified by baseline cd4 counts and viral load. within each group, participants will be randomly assigned to receive 3 injections of hepatitis b vaccine with cpg7909 odn or 3 injections of hepatitis b vaccine alone. injections will be given at study entry and months 1 and 6. there will be 10 study visits; a physical exam and blood collection will occur at each visit.

Eligibility 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

Keywords: hepatitis b vaccine treatment experienced treatment naive