PMID- 34839993 OWN - NLM STAT- MEDLINE DCOM- 20220126 LR - 20220126 IS - 1873-2518 (Electronic) IS - 0264-410X (Linking) VI - 39 IP - 51 DP - 2021 Dec 17 TI - A trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in populations of adults >/=65 years of age with different prior pneumococcal vaccination. PG - 7494-7502 LID - S0264-410X(21)01352-9 [pii] LID - 10.1016/j.vaccine.2021.10.032 [doi] AB - INTRODUCTION: A 20-valent pneumococcal conjugate vaccine, PCV20, was developed to expand protection against vaccine-preventable pneumococcal disease. PCV20 contains the components of the 13-valent pneumococcal conjugate vaccine, PCV13, and includes capsular polysaccharide conjugates for 7 additional serotypes. Thus, PCV20 may cover those additional serotypes in individuals previously vaccinated with PCV13 or provide benefits of immunization with a conjugate vaccine to individuals previously immunized with a pneumococcal polysaccharide vaccine. This study described the safety and immunogenicity of PCV20 in adults >/=65 years of age with prior pneumococcal vaccination. METHODS: This phase 3, multicenter, randomized, open-label study was conducted in the United States and Sweden. Adults >/=65 years of age were enrolled into 1 of 3 cohorts based on their prior pneumococcal vaccination history (23-valent pneumococcal polysaccharide vaccine [PPSV23], PCV13, or both PCV13 and PPSV23). Participants were randomized 2:1 within their cohort to receive a single dose of PCV20 or PCV13 in those with prior PPSV23 only, and PCV20 or PPSV23 in those with prior PCV13 only; all participants with prior PCV13 and PPSV23 received PCV20. Safety was assessed by prompted local reactions within 10 days, systemic events within 7 days, adverse events (AEs) within 1 month, and serious AEs (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination. Immune responses 1 month after PCV20 were assessed. RESULTS: The percentages of participants reporting local reactions, systemic events, and AEs after PCV20 administration were similar across cohorts and comparable with the PCV13 and PPSV23 control groups. SAE and NDCMC rates were low in all groups. Robust immune responses, including opsonophagocytic antibody responses, to the 20 vaccine serotypes were observed 1 month after PCV20 regardless of prior pneumococcal vaccination. CONCLUSIONS: PCV20 was well tolerated and immunogenic in adults >/=65 years of age previously vaccinated with different pneumococcal vaccine regimens. Clinicaltrials.gov NCT03835975. CI - Copyright (c) 2021 Elsevier Ltd. All rights reserved. FAU - Cannon, Kevin AU - Cannon K AD - PMG Research of Wilmington, LLC, Wilmington, NC, USA. FAU - Elder, Charles AU - Elder C AD - Kaiser Permanente Center for Health Research, Portland, OR, USA. FAU - Young, Mariano AU - Young M AD - Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA. Electronic address: Mariano.Young-Jr@pfizer.com. FAU - Scott, Daniel A AU - Scott DA AD - Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA. FAU - Scully, Ingrid L AU - Scully IL AD - Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA. FAU - Baugher, Gary AU - Baugher G AD - Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA. FAU - Peng, Yahong AU - Peng Y AD - Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA. FAU - Jansen, Kathrin U AU - Jansen KU AD - Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA. FAU - Gruber, William C AU - Gruber WC AD - Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA. FAU - Watson, Wendy AU - Watson W AD - Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA. LA - eng SI - ClinicalTrials.gov/NCT03835975 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20211125 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Antibodies, Bacterial) RN - 0 (Pneumococcal Vaccines) RN - 0 (Vaccines, Conjugate) SB - IM MH - Adult MH - *Antibodies, Bacterial MH - Double-Blind Method MH - Humans MH - Immunogenicity, Vaccine MH - *Pneumococcal Infections/prevention & control MH - Pneumococcal Vaccines/adverse effects MH - Streptococcus pneumoniae MH - Vaccination MH - Vaccines, Conjugate/adverse effects OTO - NOTNLM OT - Clinical trial OT - Immunogenicity OT - Pneumococcal conjugate vaccine OT - Safety OT - Streptococcus pneumoniae COIS- Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [K.C. has no disclosures to declare. CE received research funding from Pfizer Inc. M.Y., D.A.S., I.L.S., G.B., Y.P., K.U.J., W.C.G., and W.W. are employees of Pfizer and may hold stock or stock options.]. EDAT- 2021/11/30 06:00 MHDA- 2022/01/27 06:00 CRDT- 2021/11/29 05:42 PHST- 2021/08/10 00:00 [received] PHST- 2021/10/14 00:00 [revised] PHST- 2021/10/15 00:00 [accepted] PHST- 2021/11/30 06:00 [pubmed] PHST- 2022/01/27 06:00 [medline] PHST- 2021/11/29 05:42 [entrez] AID - S0264-410X(21)01352-9 [pii] AID - 10.1016/j.vaccine.2021.10.032 [doi] PST - ppublish SO - Vaccine. 2021 Dec 17;39(51):7494-7502. doi: 10.1016/j.vaccine.2021.10.032. Epub 2021 Nov 25.