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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
97
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, Denmark
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 platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.