Immune Response to Toll-Like Receptor 9-Agonist Adjuvanted Pneumococcal Vaccination in HIV Infected Adults (ITAP)
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ClinicalTrials.gov Identifier: NCT00562939 |
Recruitment Status
:
Completed
First Posted
: November 26, 2007
Last Update Posted
: January 21, 2009
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Biological: Pneumococcal vaccines + CPG 7909 Biological: Pneumococcal vaccines | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 97 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Immune Response to Toll-Like Receptor 9-Agonist Adjuvanted Pneumococcal Vaccination in HIV Infected Adults |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | January 2009 |
Actual Study Completion Date : | January 2009 |

Arm | Intervention/treatment |
---|---|
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
|
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00562939
Denmark | |
Department of Infectious Diseases, Aarhus University Hospital | |
Aarhus, Denmark, 8200 |
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 |
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 |
First Posted: | November 26, 2007 Key Record Dates |
Last Update Posted: | January 21, 2009 |
Last Verified: | January 2009 |
Keywords provided by University of Aarhus:
Antibody Formation Antibody Affinity Immunity Pneumococcal Vaccines Oligodeoxyribonucleotides |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Vaccines Antibodies Heptavalent Pneumococcal Conjugate Vaccine Immunologic Factors Physiological Effects of Drugs |