NCT00562939|CompletedPhase 1/2
Immune Response to Toll-Like Receptor 9-Agonist Adjuvanted Pneumococcal Vaccination in HIV Infected Adults
ITAP
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ITAP
Sponsor study identifier
interventional
97
1 country
1
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2009
Actual (reported)Study Completion
January 2009
Actual (reported)The purpose of this study is to determine whether TLR-9 adjuvanted pneumococcal is more immunogenic than pneumococcal vaccination alone in HIV-infected adults.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2009
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.
November 23, 2007
Actual (reported)November 26, 2007
Actual (reported)January 2008
Date type not reportedThis date has not been verified as actual or estimated.
January 2009
Actual (reported)January 2009
Actual (reported)Numbers of vaccine high responders - defined as 2-fold increase and IgG levels ≥1 µg/mL to at least 5 of 7 pneumococcal serotypes (by quantitative IgG measurements) - in the CpG 7909 group vs. the control group
At day 270
Functional activity of anticapsular antibodies measured by OPA
At day 90, 120, 270, 300
Safety/Tolerability
During the entire trial period
Nasopharyngeal pneumococcal colonization
At day 270
Predictors of antibody response, i.e. CD4+ cell count and sCD163
At baseline
Numbers of vaccine high responders - defined as 2-fold increase and IgG levels ≥1 µg/mL to at least 5 of 7 pneumococcal serotypes (by quantitative IgG measurements) - in the CpG 7909 group vs. the control group
At day 90,120 and 300
1 mg CpG 7909 + pneumococcal vaccines
Pneumococcal vaccines
Day 0: 1 ml Prevenar (double dose) + 1 mg CpG 7909, IM Day 90: 1 ml Prevenar (double dose) + 1 mg CpG 7909, IM Day 270: 0.5 ml Pneumo Novum + 1 mg CpG 7909, IM
Day 0: 1 ml Prevenar (double dose) + placebo, IM Day 90: 1 ml Prevenar (double dose) + placebo, IM Day 270: 0.5 ml Pneumo Novum + placebo, IM
Department of Infectious Diseases, Aarhus University Hospital
Aarhus, 8200, Denmark
Offersen R, Melchjorsen J, Paludan SR, Ostergaard L, Tolstrup M, Sogaard OS. TLR9-adjuvanted pneumococcal conjugate vaccine induces antibody-independent memory responses in HIV-infected adults. Hum Vaccin Immunother. 2012 Aug;8(8):1042-7. doi: 10.4161/hv.20707. Epub 2012 Aug 1.
Sogaard OS, Lohse N, Harboe ZB, Offersen R, Bukh AR, Davis HL, Schonheyder HC, Ostergaard L. Improving the immunogenicity of pneumococcal conjugate vaccine in HIV-infected adults with a toll-like receptor 9 agonist adjuvant: a randomized, controlled trial. Clin Infect Dis. 2010 Jul 1;51(1):42-50. doi: 10.1086/653112.
Ole Sogaard, MD
Department of Infectious Diseases, Aarhus University Hospital, Denmark
Lars Ostergaard, MD,PhD,DmSC
Department of Infectious Diseases, Aarhus University Hospital, Denmark
97 participants (actual enrollment reported by the registry).
First Submitted
November 23, 2007
First Posted
November 26, 2007
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
January 2009
Actual (reported)Study Completion
January 2009
Actual (reported)Last Updated
January 21, 2009
Record last verified: 2009-01
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Source: ClinicalTrials.gov.
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