Immune Response to Toll-Like Receptor 9-Agonist Adjuvanted Pneumococcal Vaccination in HIV Infected Adults (ITAP)

This study has been completed.
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00562939
First received: November 23, 2007
Last updated: January 20, 2009
Last verified: January 2009

November 23, 2007
January 20, 2009
January 2008
January 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00562939 on ClinicalTrials.gov Archive Site
  • Functional activity of anticapsular antibodies measured by OPA [ Time Frame: At day 90, 120, 270, 300 ] [ Designated as safety issue: No ]
  • Safety/Tolerability [ Time Frame: During the entire trial period ] [ Designated as safety issue: Yes ]
  • Nasopharyngeal pneumococcal colonization [ Time Frame: At day 270 ] [ Designated as safety issue: No ]
  • Predictors of antibody response, i.e. CD4+ cell count and sCD163 [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Quantity and differentiation of IgG subtypes for HAART-experienced and HAART-naive individuals [ Time Frame: Day 0, 90, 120 ] [ Designated as safety issue: No ]
  • Cytokine response to various antigens by in vitro cell stimulation for HAART-experienced and HAART-naive individuals [ Time Frame: At day 0, 90, 120 ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Immune Response to Toll-Like Receptor 9-Agonist Adjuvanted Pneumococcal Vaccination in HIV Infected Adults
Immune Response to Toll-Like Receptor 9-Agonist Adjuvanted Pneumococcal Vaccination in HIV Infected Adults

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

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
HIV Infections
  • Biological: Pneumococcal vaccines + CPG 7909
    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
    Other Name: Cpg 7909/Vaximmune(TM)
  • Biological: Pneumococcal vaccines
    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
  • Experimental: A
    1 mg CpG 7909 + pneumococcal vaccines
    Intervention: Biological: Pneumococcal vaccines + CPG 7909
  • Placebo Comparator: B
    Pneumococcal vaccines
    Intervention: Biological: Pneumococcal vaccines

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
97
January 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written informed consent and authority statement provided according to local regulatory and ethical practice using a participant information sheet and informed consent form approved by the responsible Ethics Committee.
  • HIV-seropositive individuals.

Exclusion Criteria:

  • Pregnancy as determined by a positive urine beta-hCG (if female)
  • Participant unwilling to use reliable contraception methods for the duration of the trial. Reliable methods of birth control include: pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; surgical sterilization; vaginal ring; intrauterine device; abstinence; and post-menopause (if female)
  • Currently breast-feeding (if female)
  • Latest CD4 count < 200 x106 cells/µL
  • Viral load (HIV RNA) > 50 copies/mL if on HAART (defined as at least three antiretrovirals including either a protease inhibitor or a NNRTI, i.e. combivir 300/150 mg x2 + stocrin 600 mg x1 for a minimum of 6 months)
  • Previous enrollment in this study
  • Any medical, psychiatric, social, or occupational condition or other responsibility that, in the judgment of the Principal Investigator (PI), would interfere with the evaluation of study objectives (such as severe alcohol abuse, severe drug abuse, dementia)
  • Unable to follow protocol regimen
  • Pneumococcal vaccination 5 years or less prior to inclusion
  • Planned participation in other vaccination trials during the time of the study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00562939
2007-001588-31
No
Ole Søgaard, MD, Department of Infectious Diseases, Skejby
University of Aarhus
Aarhus University Hospital
Principal Investigator: Ole Sogaard, MD Department of Infectious Diseases, Aarhus University Hospital, Denmark
Study Director: Lars Ostergaard, MD,PhD,DmSC Department of Infectious Diseases, Aarhus University Hospital, Denmark
University of Aarhus
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP