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
  Purpose

The purpose of this study is to determine whether TLR-9 adjuvanted pneumococcal is more immunogenic than pneumococcal vaccination alone in HIV-infected adults.


Condition Intervention Phase
HIV Infections
Biological: Pneumococcal vaccines + CPG 7909
Biological: Pneumococcal vaccines
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immune Response to Toll-Like Receptor 9-Agonist Adjuvanted Pneumococcal Vaccination in HIV Infected Adults

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 97
Study Start Date: January 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
1 mg CpG 7909 + pneumococcal vaccines
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)
Placebo Comparator: B
Pneumococcal vaccines
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562939

Locations
Denmark
Department of Infectious Diseases, Aarhus University Hospital
Aarhus, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
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
  More Information

No publications provided by University of Aarhus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ole Søgaard, MD, Department of Infectious Diseases, Skejby
ClinicalTrials.gov Identifier: NCT00562939     History of Changes
Other Study ID Numbers: 2007-001588-31
Study First Received: November 23, 2007
Last Updated: January 20, 2009
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Antibody Formation
Antibody Affinity
Immunity
Pneumococcal Vaccines
Oligodeoxyribonucleotides

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 16, 2014