Status:
COMPLETED
Safety of and Immune Response to a Hepatitis B Virus Vaccine Given With a Booster (CpG7909 ODN) in HIV Infected and HIV Uninfected People
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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 H...
Detailed 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 a...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00100633
Start Date
December 1 2004
End Date
October 1 2007
Last Update
October 1 2008
Active Locations (1)
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1
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106