PMID- 32716500
OWN - NLM
STAT- MEDLINE
DCOM- 20211020
LR  - 20220531
IS  - 1537-6591 (Electronic)
IS  - 1058-4838 (Print)
IS  - 1058-4838 (Linking)
VI  - 73
IP  - 7
DP  - 2021 Oct 5
TI  - Safety, Tolerability, and Immunogenicity of a 20-Valent Pneumococcal Conjugate 
      Vaccine (PCV20) in Adults 60 to 64 Years of Age.
PG  - e1489-e1497
LID - 10.1093/cid/ciaa1045 [doi]
AB  - BACKGROUND: Pneumococcal conjugate vaccines (PCVs) have significantly decreased 
      pneumococcal disease worldwide; however, expanding serotype coverage may further 
      reduce disease burden. A 20-valent PCV (PCV20) containing capsular polysaccharide 
      conjugates of serotypes present in the 13-valent PCV (PCV13) and 7 new serotypes 
      (8, 10A, 11A, 12F, 15B, 22F, and 33F) is currently in development. This phase 2 
      study evaluated safety, tolerability, and immunogenicity of PCV20 in adults 
      without prior pneumococcal vaccination. METHODS: In this randomized, 
      active-controlled, double-blinded trial, 444 adults 60 through 64 years of age 
      were randomized to receive either a single dose of PCV20 followed 1 month later 
      by saline placebo or a single dose of PCV13 followed 1 month later by 23-valent 
      polysaccharide vaccine. Local injection site reactions, select systemic symptoms, 
      and adverse events (AEs) were recorded. Immunogenicity was assessed by measuring 
      serotype-specific opsonophagocytic activity (OPA) titers before and approximately 
      1 month after each vaccination. RESULTS: Local reaction and systemic event rates 
      were similar after vaccination with PCV20 or PCV13; no serious vaccine-related 
      AEs were reported. In the PCV20 group, functional immune responses as measured by 
      OPA were robust for all 20 serotypes included in the vaccine, with geometric mean 
      fold rises from baseline ranging from 6.0 to 113.4. CONCLUSIONS: PCV20 was well 
      tolerated in adults 60 to 64 years of age, with a safety profile consistent with 
      historical experience of PCVs in this age group. Substantial OPA responses were 
      elicited against all serotypes. Results demonstrate the potential for PCV20 to 
      expand pneumococcal disease protection. CLINICAL TRIALS REGISTRATION: 
      NCT03313037.
CI  - (c) The Author(s) 2020. Published by Oxford University Press for the Infectious 
      Diseases Society of America.
FAU - Hurley, Donald
AU  - Hurley D
AD  - Medical Research South, LLC, Charleston, South Carolina, USA.
FAU - Griffin, Carl
AU  - Griffin C
AD  - Lynn Health Science Institute, Oklahoma City, Oklahoma, USA.
FAU - Young, Mariano
AU  - Young M
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania, USA.
FAU - Scott, Daniel A
AU  - Scott DA
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania, USA.
FAU - Pride, Michael W
AU  - Pride MW
AD  - Vaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.
FAU - Scully, Ingrid L
AU  - Scully IL
AD  - Vaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.
FAU - Ginis, John
AU  - Ginis J
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania, USA.
FAU - Severs, Joseph
AU  - Severs J
AD  - Vaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.
FAU - Jansen, Kathrin U
AU  - Jansen KU
AD  - Vaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.
FAU - Gruber, William C
AU  - Gruber WC
AD  - Vaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.
FAU - Watson, Wendy
AU  - Watson W
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03313037
GR  - SAF2016-80033-R/Pfizer Inc./
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Infect Dis
JT  - Clinical infectious diseases : an official publication of the Infectious Diseases 
      Society of America
JID - 9203213
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Pneumococcal Vaccines)
RN  - 0 (Vaccines, Conjugate)
SB  - IM
MH  - *Antibodies, Bacterial
MH  - Double-Blind Method
MH  - Humans
MH  - Immunogenicity, Vaccine
MH  - Middle Aged
MH  - *Pneumococcal Infections/prevention & control
MH  - Pneumococcal Vaccines/adverse effects
MH  - Serogroup
MH  - Vaccines, Conjugate/adverse effects
PMC - PMC8492133
OTO - NOTNLM
OT  - Streptococcus pneumoniae
OT  - 20-valent pneumococcal conjugate vaccine
OT  - adult
OT  - clinical trial
OT  - immunogenicity and safety
EDAT- 2020/07/28 06:00
MHDA- 2021/10/21 06:00
PMCR- 2020/07/27
CRDT- 2020/07/28 06:00
PHST- 2020/03/20 00:00 [received]
PHST- 2020/07/20 00:00 [accepted]
PHST- 2020/07/28 06:00 [pubmed]
PHST- 2021/10/21 06:00 [medline]
PHST- 2020/07/28 06:00 [entrez]
PHST- 2020/07/27 00:00 [pmc-release]
AID - 5876773 [pii]
AID - ciaa1045 [pii]
AID - 10.1093/cid/ciaa1045 [doi]
PST - ppublish
SO  - Clin Infect Dis. 2021 Oct 5;73(7):e1489-e1497. doi: 10.1093/cid/ciaa1045.