Phase 3
N=303
Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in HIV-Infected Subjects 6 Years of Age or Older Who Are Naive to Pneumococcal Vaccine
HIV Infections · Pneumococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT00962780 ↗Enrolled (actual)
303
Serious AEs
0.5%
Results posted
Nov 2014
Primary outcome: Primary: Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants — 1.03; 1.05; 1.09; 1.01 fold rise
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 13-valent Pneumococcal Conjugate Vaccine (13vPnC) (Biological); 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) (Biological); Blood draw (Procedure)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants |
1.03; 1.05; 1.09; 1.01; 1.02; 1.04 | — |
| SECONDARY Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants |
3.88; 3.95; 3.92; 4.14; 3.92; 4.03 | — |
| SECONDARY Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants |
51; 54; 52; 69; 69; 69 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants |
1.3; 1.3; 1.3; 1.4; 1.6; 1.5 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants |
1.07; 0.99; 1.01; 1.09; 1.10; 1.07 | — |
Summary
The study will evaluate the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 6 years of age or older who have not been previously immunized with a pneumococcal vaccine. All subjects will receive 3 doses of 13vPnC and 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), with each dose given approximately 1 month apart.
Eligibility Criteria
Inclusion Criteria
- Human immunodeficiency virus (HIV)-infected subjects aged 6 years or older
- Viral load = 200/uL within 6 months before study vaccination
- Receiving stable highly active antiretroviral therapy (HAART) or not currently receiving any antiretroviral therapy
- No previous vaccination with a pneumococcal vaccine
- Subject or parent/legal guardian able to complete an electronic diary
Exclusion Criteria
- Acquired immune deficiency syndrome (AIDS) at time of enrollment
- Current illicit substance and/or alcohol abuse
- History of active chronic viral hepatitis
- Previous anaphylactic reaction to a vaccine or vaccine-related component
- Serious chronic disorders including metastatic malignancy and end-stage renal disease
Data sourced from ClinicalTrials.gov (NCT00962780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.