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Completed

NCT Number: NCT00562939

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Infectious Diseases, Aarhus University Hospital

Aarhus, 8200, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pneumococcal vaccines + CPG 7909

Biological

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 names: Cpg 7909/Vaximmune(TM)

Pneumococcal vaccines

Biological

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Functional activity of anticapsular antibodies measured by OPA

    Time frame: At day 90, 120, 270, 300

  2. Safety/Tolerability

    Time frame: During the entire trial period

  3. Nasopharyngeal pneumococcal colonization

    Time frame: At day 270

  4. Predictors of antibody response, i.e. CD4+ cell count and sCD163

    Time frame: At baseline

  5. 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

  6. Quantity and differentiation of IgG subtypes for HAART-experienced and HAART-naive individuals

    Time frame: Day 0, 90, 120

  7. Cytokine response to various antigens by in vitro cell stimulation for HAART-experienced and HAART-naive individuals

    Time frame: At day 0, 90, 120

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Acronym: ITAP

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 26, 2007
Registry last updated
Jan 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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