Gretchen Tamms, United States of America
Merck & Co., Inc. GSMPAuthor Of 3 Presentations
SEQUENTIAL ADMINISTRATION OF PREVNAR 13™ AND PNEUMOVAX™ 23 IN HEALTHY PARTICIPANTS 50 YEARS OF AGE AND OLDER (ID 490)
- Ulrike Buckwald, United States of America
- Charles Andrews, United States of America
- John Ervin, United States of America
- James Peterson, United States of America
- Gretchen Tamms, United States of America
- David Krupa, United States of America
- Patrick Ajiboye, United States of America
- Lucy Roalfe, United Kingdom
- Andrea Krick, United States of America
- Tina Sterling, United States of America
- Meihua Wang, United States of America
- Jason Martin, United States of America
- Jon E. Stek, United States of America
- Melvin Kohn, United States of America
- Jonathan Hartzel, United States of America
- Luwy Musey, United States of America
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.
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)
- Lerato Mohapi,
- Olayemi Osiyemi,
- Khuanchai Supparatpinyo,
- Winai Ratanasuwan,
- Jean-Michel Molina,
- Ron Dagan, Israel
- Gretchen Tamms, United States of America
- Tina Sterling, United States of America
- Jonathan Hartzel, United States of America
- Alison Pedley, United States of America
- Ying Zhan,
- Yanqing Kan,
- Kim Hurtado,
- Ulrike Buchwald, United States of America
- Luwy Musey, United States of America
- Jakub K. Simon, United States of America
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.
SAFETY AND IMMUNOGENICITY OF V114 ADMINISTERED CONCOMITANTLY WITH INFLUENZA VACCINE (PNEU-FLU) (ID 619)
- Randall Severance, United States of America
- Howard Schwartz, United States of America
- Matthew Davis, United States of America
- Kurt Lesh, United States of America
- Ron Dagan, Israel
- Laurie Connor, United States of America
- Jianing Li, United States of America
- Alison Pedley, United States of America
- Jonathan Hartzel, United States of America
- Tina Sterling, United States of America
- Katrina Nolan, United States of America
- Gretchen Tamms, United States of America
- Luwy Musey, United States of America
- Ulrike Buchwald, United States of America
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.