A Phase 1/2 interventional study of Pneumococcal vaccines + CPG 7909 and Pneumococcal vaccines in HIV Infections, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-01-21.
Sponsored by University of Aarhus · Phase 1/2, Interventional, and Prevention
The purpose of this study is to determine whether TLR-9 adjuvanted pneumococcal is more immunogenic than pneumococcal vaccination alone in HIV-infected adults.
Pneumococcal disease is a major source of morbidity and mortality in HIV-patients. HIV-patients are vaccine hyporesponders. A good immune response to pneumococcal vaccination enhances vaccine effectiveness, thereby preventing the morbidity and mortality caused by pneumococcal disease. Even when an optimized regimen containing both conjugated and polysaccharide pneumococcal vaccine is used, only 13% of the immunized HIV patients are high responders at week 96. Recent data indicate that TLR9-agonists have excellent vaccine adjuvant potential and are safe to use in immunocompetent as well as immunocompromised individuals. The aim of this study is to evaluate the qualitative and quantitive immune response to pneumococcal vaccination with or without TLR9-agonist in HIV-infected adults
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 97 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 mg CpG 7909 + pneumococcal vaccines
Biological: Pneumococcal vaccines + CPG 7909
Pneumococcal vaccines
Biological: 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
Also known as: Cpg 7909/Vaximmune(TM)
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
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
Time frame: At day 270
Functional activity of anticapsular antibodies measured by OPA
Time frame: At day 90, 120, 270, 300
Safety/Tolerability
Time frame: During the entire trial period
Nasopharyngeal pneumococcal colonization
Time frame: At day 270
Predictors of antibody response, i.e. CD4+ cell count and sCD163
Time frame: 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
Time frame: At day 90,120 and 300
Quantity and differentiation of IgG subtypes for HAART-experienced and HAART-naive individuals
Time frame: Day 0, 90, 120
Cytokine response to various antigens by in vitro cell stimulation for HAART-experienced and HAART-naive individuals
Time frame: At day 0, 90, 120
This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.
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University of Aarhus