Expired Study
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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


Study is Available At:


Original ID:

PO1AI55793


NCT ID:

NCT00100633


Secondary ID:

PO1-AI-55793


Study Acronym:


Brief Title:

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


Official Title:

Immunologic Effects of CpG ODN Administration to HIV Uninfected and HIV Infected Patients


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Allergy and Infectious Diseases (NIAID)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:


Overall Contact Information

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

Study Dates

Start Date:December 2004
Completion Date:October 2007
Completion Type:Actual
Primary Completion Date:February 2007
Primary Completion Type:Actual
Verification Date:December 2007
Last Changed Date:September 29, 2008
First Received Date:January 4, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:spontaneous IFN-gamma production in peripheral blood (CpG recipients, HIV infected vs. uninfected participants)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:expression of costimulatory molecules on B-cells in peripheral blood (CpG recipients, HIV infected vs. uninfected participants)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:expression of costimulatory molecules on B-cells in peripheral blood (CpG vs. no CpG in HIV infected participants)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:percentage of patients who develop CD8+ lymphocyte proliferative responses as measured using CFSE (CpG vs. no CpG in all participants)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:percentage of patients who develop CD8+ lymphocyte proliferative responses as measured using CFSE (CpG vs. no CpG in HIV infected participants)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:percentage of patients who develop HB specific CD8+ lymphocyte responses using ELISPOT (CpG vs. no CpG in all participants)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:percentage of patients who develop HB specific CD8+ lymphocyte responses using ELISPOT (CpG vs. no CpG in HIV infected participants)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Percentage of patients who develop protective hepatitis B (HB) antibody concentration (CpG vs. no CpG in HIV infected participants)
Safety Issues:False
Outcome Type:Primary Outcome
Measure:safety
Safety Issues:False
Outcome Type:Primary Outcome
Measure:total number of CD8+ lymphocytes responding after HIV-peptide stimulation using ELISPOT (CpG vs. no CpG in HIV infected participants)
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Number of HIV peptides to which HIV infected patients respond using ELISPOT (CpG vs. no CpG in HIV infected participants)
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:CpG7909 oligodeoxynucleotides (ODN)
Intervention Type:Biological
Name:Hepatitis B virus vaccine

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Allergy and Infectious Diseases (NIAID)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:15596832
Reference Type:Reference
Citation:Schlaepfer E, Audige 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.
PMID:15507621

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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