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

Pfizer303 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

303

Conditions

HIV Infections Pneumococcal Infections

Interventions

13-valent Pneumococcal Conjugate Vaccine (13vPnC)BIOLOGICAL

13vPnC; 3 vaccinations given at approximately 1 month intervals at visits 1-3

23-valent Pneumococcal Polysaccharide Vaccine (23vPS)BIOLOGICAL

23vPS; 1 vaccination given at visit 4 (approximately 1 month after visit 3)

Blood drawPROCEDURE

Blood draw; 5 blood draws approximately 1 month apart taken prior to vaccination at visits 1-4 and visit 5 (approximately 1 month after visit 4).

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

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

Locations (11)

Pfizer Investigational Site

Bucharest, Romania

Pfizer Investigational Site

Bucharest, Romania

Pfizer Investigational Site

Constanța, Romania

Outcomes

Primary Outcomes

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

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.

Time frame: 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3

Secondary Outcomes

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

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.

Time frame: 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3

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

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.

Data from ClinicalTrials.gov

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