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

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ClinicalTrials.gov Identifier: NCT00100633
Recruitment Status : Completed
First Posted : January 5, 2005
Last Update Posted : October 1, 2008
Sponsor:
Information provided by:

Study Description
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 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.


Condition or disease Intervention/treatment Phase
HIV Infections Hepatitis B Drug: CpG7909 oligodeoxynucleotides (ODN) Biological: Hepatitis B virus vaccine Phase 1 Phase 2

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 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Immunologic Effects of CpG ODN Administration to HIV Uninfected and HIV Infected Patients
Study Start Date : December 2004
Primary Completion Date : February 2007
Study Completion Date : October 2007

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Number of HIV peptides to which HIV infected patients respond using ELISPOT (CpG vs. no CpG in HIV infected participants)
  2. total number of CD8+ lymphocytes responding after HIV-peptide stimulation using ELISPOT (CpG vs. no CpG in HIV infected participants)
  3. safety

Secondary Outcome Measures :
  1. Percentage of patients who develop protective hepatitis B (HB) antibody concentration (CpG vs. no CpG in HIV infected participants)
  2. percentage of patients who develop HB specific CD8+ lymphocyte responses using ELISPOT (CpG vs. no CpG in HIV infected participants)
  3. percentage of patients who develop HB specific CD8+ lymphocyte responses using ELISPOT (CpG vs. no CpG in all participants)
  4. percentage of patients who develop CD8+ lymphocyte proliferative responses as measured using CFSE (CpG vs. no CpG in HIV infected participants)
  5. percentage of patients who develop CD8+ lymphocyte proliferative responses as measured using CFSE (CpG vs. no CpG in all participants)
  6. expression of costimulatory molecules on B-cells in peripheral blood (CpG vs. no CpG in HIV infected participants)
  7. expression of costimulatory molecules on B-cells in peripheral blood (CpG recipients, HIV infected vs. uninfected participants)
  8. spontaneous IFN-gamma production in peripheral blood (CpG recipients, HIV infected vs. uninfected participants)

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00100633


Locations
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Michael M. Lederman, MD University Hospitals Cleveland Medical Center
More Information

Additional Information:
Publications:
Responsible Party: Michael M. Lederman/Professor of Medicine, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT00100633     History of Changes
Other Study ID Numbers: P01AI055793 ( U.S. NIH Grant/Contract )
First Posted: January 5, 2005    Key Record Dates
Last Update Posted: October 1, 2008
Last Verified: December 2007

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Hepatitis B Vaccine
Treatment Experienced
Treatment Naive

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
HIV Infections
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs