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

Phase 3

Completed

• Conditions: HIV Infections; Pneumococcal Infections
• Interventions: Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC); Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS); Procedure: Blood draw

• Registration Number: NCT00962780
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-18
• Study First Submitted QC: 2009-08-19
• Study First Posted: 2009-08-20
• Study Start: 2010-03
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2014-03-17
• Status Verified: 2014-11
• Results First Submitted QC: 2014-11-13
• Last Update Submitted: 2014-11-13
• Results First Posted: 2014-11-17
• Last Update Posted: 2014-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 303

Inclusion Criteria

• Human immunodeficiency virus (HIV)-infected subjects aged 6 years or older
• Viral load < 50,000 copies/mL and CD4+ T cell count >= 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	13-valent Pneumococcal Conjugate Vaccine (13vPnC)	3 doses of 13vPnC and 1 dose of 23vPS, each dose given approximately 1 month apart
1	23-valent Pneumococcal Polysaccharide Vaccine (23vPS)	3 doses of 13vPnC and 1 dose of 23vPS, each dose given approximately 1 month apart
1	Blood draw	3 doses of 13vPnC and 1 dose of 23vPS, each dose given approximately 1 month apart

Primary Outcome Measures

Name	Time	Method
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 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3	GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.

Secondary Outcome Measures

Name	Time	Method
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	1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3	Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
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 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3	GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.
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	1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3	Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
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 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3	GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇿🇦 Paarl, South Africa