Sponsor study identifier
NIH
Secondary identifiers
NIH
interventional
30
1 country
1
Study Start
December 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2007
Actual (reported)Study Completion
October 2007
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2007
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2004
Date type not reportedThis date has not been verified as actual or estimated.
January 4, 2005
Actual (reported)January 5, 2005
Actual (reported)February 2007
Actual (reported)October 2007
Actual (reported)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)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University Hospitals of Cleveland
Cleveland, Ohio, 44106, 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. doi: 10.1128/JVI.79.1.393-400.2005.
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. doi: 10.1128/JVI.78.22.12344-12354.2004.
Michael M. Lederman, MD
University Hospitals Cleveland Medical Center
First Submitted
January 4, 2005
First Posted
January 5, 2005
Study Start
December 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2007
Actual (reported)Contact the study team to confirm eligibility.
Study Completion
October 2007
Actual (reported)Last Updated
October 1, 2008
Record last verified: 2007-12
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Source: ClinicalTrials.gov.
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