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Cleveland, Ohio 44106


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00100633


Primary Contact:

Principal Investigator
Michael M. Lederman, MD
University Hospitals of Cleveland


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44106
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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