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Clinical Trial
. 2022 Feb 23;40(9):1342-1351.
doi: 10.1016/j.vaccine.2021.12.067. Epub 2022 Jan 14.

Lot-to-lot consistency, safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in healthy adults aged ≥50 years: A randomized phase 3 trial (PNEU-TRUE)

Jakub K Simon  1 , Nina Breinholt Staerke  2 , Maria Hemming-Harlo  3 , Stacey Layle  4 , Ron Dagan  5 , Tulin Shekar  1 , Alison Pedley  1 , Patricia Jumes  1 , Gretchen Tamms  1 , Tina Sterling  1 , Luwy Musey  1 , Ulrike K Buchwald  6 ; V114-020 PNEU-TRUE study group
Affiliations
Clinical Trial

Lot-to-lot consistency, safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in healthy adults aged ≥50 years: A randomized phase 3 trial (PNEU-TRUE)

Jakub K Simon et al. Vaccine. .

Abstract

Background: Older adults are at risk of pneumococcal disease and associated morbidity and mortality. This phase 3 study (V114-020) assessed lot-to-lot consistency across safety and immunogenicity outcomes for V114, a 15-valent pneumococcal conjugate vaccine (PCV), in healthy adults aged ≥ 50 years.

Methods: Adults were randomized in a 3:3:3:1 ratio to receive a single dose of one of three lots of V114 or 13-valent PCV (PCV13), stratified by age (50-64 years, 65-74 years, and ≥ 75 years). Serotype-specific opsonophagocytic activity (OPA) and immunoglobulin G (IgG) antibodies were evaluated at baseline (Day 1) and 30 days post-vaccination. Non-serious and serious adverse events (AEs) were evaluated post-vaccination through 14 days and Month 6, respectively.

Results: Of 2340 participants enrolled, 2282 (97.5%) completed the study. Proportions of participants experiencing ≥ 1 AE were 81.0%, 77.4%, and 78.0% for V114 lots 1, 2, and 3, respectively. Comparison of V114 combined lots with PCV13 showed that proportions of participants experiencing AEs, solicited AEs, and serious AEs were comparable for both vaccines, with the exception of injection-site pain (more frequently reported with V114). OPA geometric mean titers (GMTs) and IgG geometric mean concentrations (GMCs) at 30 days post-vaccination were comparable across V114 lots, and all lots met predefined equivalence criteria for all 15 vaccine serotypes (lower and upper limits of the 95% confidence intervals of serotype-specific OPA GMT ratios for all possible pairwise comparisons across the three lots were within the equivalence margin of 0.5-2.0). Serotype-specific OPA GMTs and IgG GMCs were comparable in the V114 combined lots and PCV13 groups for the 13 shared serotypes and higher in the V114 group for serotypes unique to V114 (22F and 33F).

Conclusions: V114 is well tolerated with a consistent safety profile and immune response across manufacturing lots.

Clinical trials registration: NCT03950856 (www.clinicaltrials.gov); 2018-004266-33 (EudraCT).

Keywords: 15-valent PCV; Adults; Lot consistency; PCV13; Pneumococcal vaccine; V114.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Gretchen Tamms reports a relationship with Merck & Co., Inc., Kenilworth, NJ, USA that includes: employment and equity or stocks. Tulin Shekar reports a relationship with Merck & Co., Inc., Kenilworth, NJ, USA that includes: employment and equity or stocks. Tina Sterling reports a relationship with Merck & Co., Inc., Kenilworth, NJ, USA that includes: employment and equity or stocks. Alison Pedley reports a relationship with Merck & Co., Inc., Kenilworth, NJ, USA that includes: employment and equity or stocks. Patricia Jumes reports a relationship with Merck & Co., Inc., Kenilworth, NJ, USA that includes: employment and equity or stocks. Luwy Musey reports a relationship with Merck & Co., Inc., Kenilworth, NJ, USA that includes: employment and equity or stocks. Jakub K. Simon reports a relationship with Merck & Co., Inc., Kenilworth, NJ, USA that includes: employment and equity or stocks. Ulrike K. Buchwald reports a relationship with Merck & Co., Inc., Kenilworth, NJ, USA that includes: employment and equity or stocks. Ron Dagan reports a relationship with Pfizer that includes: consulting or advisory, funding grants, and speaking and lecture fees. Ron Dagan reports a relationship with Merck Sharp & Dohme that includes: consulting or advisory and funding grants. Ron Dagan reports a relationship with Medimmune that includes: funding grants. Ron Dagan reports a relationship with MeMed that includes: consulting or advisory. Ron Dagan reports a relationship with Biondvax that includes: consulting or advisory.

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