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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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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Hepatitis B |
Drug: CpG7909 oligodeoxynucleotides (ODN) Biological: Hepatitis B virus vaccine |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Immunologic Effects of CpG ODN Administration to HIV Uninfected and HIV Infected Patients |
- 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
- 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)
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2004 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| United States, Ohio | |
| University Hospitals of Cleveland | |
| Cleveland, Ohio, United States, 44106 | |
| Principal Investigator: | Michael M. Lederman, MD | University Hospitals of Cleveland |
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: | PO1AI55793, PO1-AI-55793 |
| Study First Received: | January 4, 2005 |
| Last Updated: | September 29, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Hepatitis B Vaccine Treatment Experienced Treatment Naive |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Hepatitis Hepatitis A Hepatitis B Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Hepadnaviridae Infections DNA Virus Infections |
ClinicalTrials.gov processed this record on May 19, 2013