Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00100633
First received: January 4, 2005
Last updated: September 29, 2008
Last verified: December 2007

January 4, 2005
September 29, 2008
December 2004
February 2007   (final data collection date for primary outcome measure)
  • Number of HIV peptides to which HIV infected patients respond using ELISPOT (CpG vs. no CpG in HIV infected participants)
  • total number of CD8+ lymphocytes responding after HIV-peptide stimulation using ELISPOT (CpG vs. no CpG in HIV infected participants)
  • safety
Same as current
Complete list of historical versions of study NCT00100633 on ClinicalTrials.gov Archive Site
  • Percentage of patients who develop protective hepatitis B (HB) antibody concentration (CpG vs. no CpG in HIV infected participants)
  • percentage of patients who develop HB specific CD8+ lymphocyte responses using ELISPOT (CpG vs. no CpG in HIV infected participants)
  • percentage of patients who develop HB specific CD8+ lymphocyte responses using ELISPOT (CpG vs. no CpG in all participants)
  • percentage of patients who develop CD8+ lymphocyte proliferative responses as measured using CFSE (CpG vs. no CpG in HIV infected participants)
  • percentage of patients who develop CD8+ lymphocyte proliferative responses as measured using CFSE (CpG vs. no CpG in all participants)
  • expression of costimulatory molecules on B-cells in peripheral blood (CpG vs. no CpG in HIV infected participants)
  • expression of costimulatory molecules on B-cells in peripheral blood (CpG recipients, HIV infected vs. uninfected participants)
  • spontaneous IFN-gamma production in peripheral blood (CpG recipients, HIV infected vs. uninfected participants)
Same as current
Not Provided
Not Provided
 
Safety of and Immune Response to a Hepatitis B Virus Vaccine Given With a Booster (CpG7909 ODN) in HIV Infected and HIV Uninfected People
Immunologic Effects of CpG ODN Administration to HIV Uninfected and HIV Infected Patients

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • HIV Infections
  • Hepatitis B
  • Drug: CpG7909 oligodeoxynucleotides (ODN)
  • Biological: Hepatitis B virus vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2007
February 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00100633
PO1AI55793, PO1-AI-55793
Not Provided
Michael M. Lederman/Professor of Medicine, Case Western Reserve University
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: Michael M. Lederman, MD University Hospital Case Medical Center
National Institute of Allergy and Infectious Diseases (NIAID)
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP