HIV Infections Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 2007 |
Est. primary completion date | February 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals of Cleveland | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Jiang JQ, Patrick A, Moss RB, Rosenthal KL. CD8+ T-cell-mediated cross-clade protection in the genital tract following intranasal immunization with inactivated human immunodeficiency virus antigen plus CpG oligodeoxynucleotides. J Virol. 2005 Jan;79(1):393-400. — View Citation
Schlaepfer E, Audigé A, von Beust B, Manolova V, Weber M, Joller H, Bachmann MF, Kundig TM, Speck RF. CpG oligodeoxynucleotides block human immunodeficiency virus type 1 replication in human lymphoid tissue infected ex vivo. J Virol. 2004 Nov;78(22):12344-54. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of HIV peptides to which HIV infected patients respond using ELISPOT (CpG vs. no CpG in HIV infected participants) | |||
Primary | total number of CD8+ lymphocytes responding after HIV-peptide stimulation using ELISPOT (CpG vs. no CpG in HIV infected participants) | |||
Primary | safety | |||
Secondary | Percentage of patients who develop protective hepatitis B (HB) antibody concentration (CpG vs. no CpG in HIV infected participants) | |||
Secondary | percentage of patients who develop HB specific CD8+ lymphocyte responses using ELISPOT (CpG vs. no CpG in HIV infected participants) | |||
Secondary | percentage of patients who develop HB specific CD8+ lymphocyte responses using ELISPOT (CpG vs. no CpG in all participants) | |||
Secondary | percentage of patients who develop CD8+ lymphocyte proliferative responses as measured using CFSE (CpG vs. no CpG in HIV infected participants) | |||
Secondary | percentage of patients who develop CD8+ lymphocyte proliferative responses as measured using CFSE (CpG vs. no CpG in all participants) | |||
Secondary | expression of costimulatory molecules on B-cells in peripheral blood (CpG vs. no CpG in HIV infected participants) | |||
Secondary | expression of costimulatory molecules on B-cells in peripheral blood (CpG recipients, HIV infected vs. uninfected participants) | |||
Secondary | spontaneous IFN-gamma production in peripheral blood (CpG recipients, HIV infected vs. uninfected participants) |
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