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

NCT00562939 | Completed Phase 1

• 1 other identifier: 2007-001588-31
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Antibody Formation; Antibody Affinity; Immunity; Pneumococcal Vaccines; Oligodeoxyribonucleotides

Outcome Measures

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

  At day 270

Secondary Outcomes (7)

• Functional activity of anticapsular antibodies measured by OPA

  At day 90, 120, 270, 300

• Safety/Tolerability

  During the entire trial period

• Nasopharyngeal pneumococcal colonization

  At day 270

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

  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

  At day 90,120 and 300

Study Arms (2)

A

EXPERIMENTAL

1 mg CpG 7909 + pneumococcal vaccines

Biological: Pneumococcal vaccines + CPG 7909

B

PLACEBO COMPARATOR

Pneumococcal vaccines

Biological: Pneumococcal vaccines

Interventions

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

Also known as: Cpg 7909/Vaximmune(TM)

A

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

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Planned participation in other vaccination trials during the time of the study

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Department of Infectious Diseases, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Related Publications (2)

• 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.

  PMID: 22854665 DERIVED

• 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.

  PMID: 20504165 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Pneumococcal Vaccines; ProMune

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Ole Sogaard, MD

  Department of Infectious Diseases, Aarhus University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

• Lars Ostergaard, MD,PhD,DmSC

  Department of Infectious Diseases, Aarhus University Hospital, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 23, 2007
• First Posted: November 26, 2007
• Study Start: January 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: January 21, 2009

Record last verified: 2009-01

Locations

DK (1)