Gretchen Tamms, United States of America

Merck & Co., Inc. GSMP

Poster Author Of 3 e-Posters

 ePoster
Online Abstracts Vaccines - Pneumococcal Vaccines Development C1 Pneumococcal Vaccines Development

SEQUENTIAL ADMINISTRATION OF PREVNAR 13™ AND PNEUMOVAX™ 23 IN HEALTHY PARTICIPANTS 50 YEARS OF AGE AND OLDER

Presenter
Authors
Presentation Type
Abstract_Submission
Presentation Topic
C1 Pneumococcal Vaccines Development
Online Abstracts Clinical Sciences - Treatment of Pneumococcal Disease in Infants, Children/Youth, and Adults B5 Treatment of Pneumococcal Disease in Infants, Children/Youth, and Adults

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

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Authors
Presentation Type
Abstract_Submission
Presentation Topic
B5 Treatment of Pneumococcal Disease in Infants, Children/Youth, and Adults
Online Abstracts Vaccines - Pneumococcal Vaccines Development C1 Pneumococcal Vaccines Development

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

Presenter
Authors
Presentation Type
Abstract_Submission
Presentation Topic
C1 Pneumococcal Vaccines Development

Author Of 3 Presentations

 Conference Calendar

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)

Session Name
Vaccines - Pneumococcal Vaccines Development
Presenter
Authors

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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SEQUENTIAL ADMINISTRATION OF PREVNAR 13™ AND PNEUMOVAX™ 23 IN HEALTHY PARTICIPANTS 50 YEARS OF AGE AND OLDER (ID 490)

Session Name
Vaccines - Pneumococcal Vaccines Development
Presenter
Authors

Abstract

Background

Widespread use of the 13-valent pneumococcal conjugate vaccine (PCV13) in infants and the associated indirect protection in adults has highlighted the significant burden of pneumococcal disease caused by serotypes unique to 23-valent pneumococcal polysaccharide vaccine (PPSV23) in older adults.

Methods

This study evaluated the safety and immunogenicity of sequential administration of PCV13 followed by PPSV23 either 8 weeks (Group#1) or 26 weeks (Group#2) later in adults ≥50 years old. Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) were measured prior and 30 days postvaccination.

Results

Proportions of participants reporting any AE were comparable between both groups. More participants in Group#1 (81.9%) reported injection site AEs following PPSV23 than Group#2 (64.0%). At Week 12, OPA GMTs to 12 shared serotypes between PPSV23 and PCV13 in Group#1 were noninferior to Group#2; OPA GMTs to 6 serotypes unique to PPSV23 were superior in Group#1 than Group#2. Overall, OPA GMTs for all tested serotypes were comparable by Week 30, after both groups had received PCV13 and PPSV23.

Conclusions

Sequential administration of PCV13 followed by PPSV23 at 2-month or 6-month intervals was generally well-tolerated. Serotype-specific OPA GMTs were comparable, regardless of dosing interval. Administration of PPSV23 did not hinder immune responses induced by PCV13.

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

Session Name
Clinical Sciences - Treatment of Pneumococcal Disease in Infants, Children/Youth, and Adults
Presenter
Authors

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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