Abstract | INTRODUCTION: Introduction of pneumococcal conjugate vaccines (PCVs), including the 13-valent PCV (PCV13), has considerably reduced pneumococcal disease burden. However, additional serotypes not in PCV13 continue to present a substantial disease burden. The 20-valent PCV (PCV20) was developed to expand protection against pneumococcal disease beyond PCV13. As part of the phase 3 clinical development program, the current study assessed consistency of immune responses across 3 lots of PCV20 and described the safety profile of PCV20. METHODS: This phase 3, randomized, multicenter, double-blind study of pneumococcal vaccine-naive adults 18-49 years of age randomized 1710 participants in a 2:2:2:1 ratio to receive 1 of 3 lots of PCV20 or PCV13. Immunogenicity was assessed through serotype-specific opsonophagocytic activity (OPA) titers before and approximately 1 month (28-42 days) after vaccination. Reported local reactions within 10 days, systemic events within 7 days, adverse events (AEs) within 30 days, and serious AEs (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination were evaluated. RESULTS: Equivalence in immune responses (OPA geometric mean titers) for all 20 vaccine serotypes was demonstrated across the 3 PCV20 lots. Robust responses, assessed by OPA geometric mean fold rises, percentage of participants achieving ≥4-fold rises, and percentage of participants with OPA titers ≥lower limit of quantitation, were observed after PCV20. Reported rates of local reactions, systemic events, and AEs were similar between the pooled PCV20 lots and PCV13; most events were mild or moderate. Reported rates of SAEs and NDCMCs were low and similar between the PCV20 and PCV13 groups. CONCLUSIONS: Three different lots of PCV20 demonstrated robust and consistent immunogenicity. The safety and tolerability of PCV20 was acceptable and similar to that of PCV13. (Clinicaltrials.gov: NCT03828617).
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Authors | Nicola P Klein, Paula Peyrani, Kari Yacisin, Nicole Caldwell, Xia Xu, Ingrid L Scully, Daniel A Scott, Kathrin U Jansen, William C Gruber, Wendy Watson |
Journal | Vaccine
(Vaccine)
Vol. 39
Issue 38
Pg. 5428-5435
(09 07 2021)
ISSN: 1873-2518 [Electronic] Netherlands |
PMID | 34315611
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2021 Elsevier Ltd. All rights reserved. |
Chemical References |
- Antibodies, Bacterial
- Pneumococcal Vaccines
- Vaccines, Conjugate
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Topics |
- Adolescent
- Adult
- Antibodies, Bacterial
- Double-Blind Method
- Humans
- Middle Aged
- Pneumococcal Infections
(prevention & control)
- Pneumococcal Vaccines
(adverse effects)
- Vaccines, Conjugate
(adverse effects)
- Young Adult
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