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

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Hepatitis B

HIV Infections

Treatments

Biological: Hepatitis B virus vaccine

Drug: CpG7909 oligodeoxynucleotides (ODN)

Study type

Interventional

Funder types

NIH

Identifiers

NCT00100633

P01AI055793 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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