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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Pneumococcal vaccines + CPG 7909
Pneumococcal vaccines
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Antibody Formation, Antibody Affinity, Immunity, Pneumococcal Vaccines, Oligodeoxyribonucleotides

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Infectious Diseases, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

1 mg CpG 7909 + pneumococcal vaccines

Pneumococcal vaccines

Outcomes

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

Secondary Outcome Measures

Functional activity of anticapsular antibodies measured by OPA
Safety/Tolerability
Nasopharyngeal pneumococcal colonization
Predictors of antibody response, i.e. CD4+ cell count and sCD163
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
Quantity and differentiation of IgG subtypes for HAART-experienced and HAART-naive individuals
Cytokine response to various antigens by in vitro cell stimulation for HAART-experienced and HAART-naive individuals

Full Information

First Posted
November 23, 2007
Last Updated
January 20, 2009
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00562939
Brief Title
Immune Response to Toll-Like Receptor 9-Agonist Adjuvanted Pneumococcal Vaccination in HIV Infected Adults
Acronym
ITAP
Official Title
Immune Response to Toll-Like Receptor 9-Agonist Adjuvanted Pneumococcal Vaccination in HIV Infected Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Antibody Formation, Antibody Affinity, Immunity, Pneumococcal Vaccines, Oligodeoxyribonucleotides

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
1 mg CpG 7909 + pneumococcal vaccines
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Pneumococcal vaccines
Intervention Type
Biological
Intervention Name(s)
Pneumococcal vaccines + CPG 7909
Other Intervention Name(s)
Cpg 7909/Vaximmune(TM)
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Pneumococcal vaccines
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Functional activity of anticapsular antibodies measured by OPA
Time Frame
At day 90, 120, 270, 300
Title
Safety/Tolerability
Time Frame
During the entire trial period
Title
Nasopharyngeal pneumococcal colonization
Time Frame
At day 270
Title
Predictors of antibody response, i.e. CD4+ cell count and sCD163
Time Frame
At baseline
Title
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
Title
Quantity and differentiation of IgG subtypes for HAART-experienced and HAART-naive individuals
Time Frame
Day 0, 90, 120
Title
Cytokine response to various antigens by in vitro cell stimulation for HAART-experienced and HAART-naive individuals
Time Frame
At day 0, 90, 120

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ole Sogaard, MD
Organizational Affiliation
Department of Infectious Diseases, Aarhus University Hospital, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lars Ostergaard, MD,PhD,DmSC
Organizational Affiliation
Department of Infectious Diseases, Aarhus University Hospital, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Department of Infectious Diseases, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
22854665
Citation
Offersen R, Melchjorsen J, Paludan SR, Ostergaard L, Tolstrup M, Sogaard OS. TLR9-adjuvanted pneumococcal conjugate vaccine induces antibody-independent memory responses in HIV-infected adults. Hum Vaccin Immunother. 2012 Aug;8(8):1042-7. doi: 10.4161/hv.20707. Epub 2012 Aug 1.
Results Reference
derived
PubMed Identifier
20504165
Citation
Sogaard OS, Lohse N, Harboe ZB, Offersen R, Bukh AR, Davis HL, Schonheyder HC, Ostergaard L. Improving the immunogenicity of pneumococcal conjugate vaccine in HIV-infected adults with a toll-like receptor 9 agonist adjuvant: a randomized, controlled trial. Clin Infect Dis. 2010 Jul 1;51(1):42-50. doi: 10.1086/653112.
Results Reference
derived

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

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