Alison Pedley, United States of America

Merck & Co., Inc. Research

Poster Author Of 2 e-Posters

Author Of 2 Presentations

SAFETY AND IMMUNOGENICITY OF V114 ADMINISTERED CONCOMITANTLY WITH INFLUENZA VACCINE (PNEU-FLU) (ID 619)

Abstract

Background

Streptococcus pneumoniae and influenza virus are significant causes of disease worldwide. V114, an investigational 15-valent PCV, contains all serotypes in PCV13 plus serotypes 22F and 33F. This phase 3 trial evaluated safety and immunogenicity of concomitant and non-concomitant administration of V114 and quadrivalent influenza vaccine (QIV) in adults aged ≥50 years.

Methods

Overall, 1200 participants were randomized 1:1 to receive either V114 administered concomitantly with QIV (concomitant group) or V114 administered 1 month after QIV (non-concomitant group); randomization was stratified by age and history of prior pneumococcal polysaccharide vaccine. Pneumococcal serotype-specific opsonophagocytic activity (OPA) and influenza strain-specific hemagglutination inhibition (HAI) antibodies were measured prior and 30 days postvaccination. Demonstration of non-inferior immunogenicity between the concomitant and non-concomitant group required the lower bound of the 95% confidence interval of the ratio of OPA and HAI geometric mean titers (GMTs) to be ≥0.5.

Results

Proportions of participants reporting any AE, injection-site AEs, and systemic AEs were generally comparable between vaccination groups. Non-inferiority was demonstrated for all 15 pneumococcal serotypes and all 4 influenza strains between vaccination groups.

Conclusions

V114 administered concomitantly with QIV was generally well tolerated and immunologically non-inferior to non-concomitant administration, supporting co-administration of both vaccines.

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SAFETY AND IMMUNOGENICITY OF V114, A 15-VALENT PNEUMOCOCCAL CONJUGATE VACCINE (PCV), IN ADULTS INFECTED WITH HUMAN IMMUNODEFICIENCY VIRUS (HIV): A PHASE 3 TRIAL (ID 985)

Abstract

Background

HIV infection increases the risk of pneumococcal disease (PD). Sequential vaccination with pneumococcal conjugate vaccine (PCV) followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) is recommended for prevention of PD. V114, an investigational 15-valent PCV, contains all serotypes in PCV13 plus serotypes 22F and 33F. This phase 3 trial evaluated immunogenicity and safety of V114 or PCV13 followed 8 weeks later by PPSV23 in HIV-infected adults.

Methods

Eligible HIV-infected adults aged ≥18 years, pneumococcal vaccine naïve and receiving antiretroviral therapy were randomized 1:1 to receive either V114 or PCV13 followed by PPSV23. Randomization was stratified by CD4 cell count. Serotype-specific opsonophagocytic activity (OPA) and immunoglobulin G (IgG) antibodies were measured immediately prior and 30 days after each vaccination.

Results

Enrollment of study participants has been completed. Safety outcomes and serotype-specific OPA geometric mean titers and IgG geometric mean concentrations following vaccination with V114 or PCV13 will be summarized by vaccination group (primary). Sub-group analysis will include CD4 strata if there are more than 10 participants per group. Summaries of safety and immunogenicity outcomes following PPV23 will also be provided.

Conclusions

Findings will demonstrate whether immunization with V114 or PCV13 followed by PPSV23 is well-tolerated and immunogenic in HIV-infected adults.

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