PMID- 33545022
OWN - NLM
STAT- MEDLINE
DCOM- 20210709
LR  - 20210709
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 17
IP  - 7
DP  - 2021 Jul 3
TI  - A randomized phase 1 study of the safety and immunogenicity of 2 novel 
      pneumococcal conjugate vaccines in healthy Japanese adults in the United States.
PG  - 2249-2256
LID - 10.1080/21645515.2020.1863177 [doi]
AB  - Expanding serotype coverage of pneumococcal conjugate vaccines (PCVs) to target 
      prevailing disease-causing serotypes could further reduce disease burden. To 
      address this need, 2 different PCVs have been investigated: a 20-valent PCV 
      (PCV20; includes the 13 serotypes in the 13-valent PCV [PCV13] plus 7 additional 
      serotypes [8, 10A, 11A, 12F, 15B, 22F, 33F]) and a complementary 7-valent PCV 
      (cPCV7; contains only the 7 additional serotypes). This phase 1b, randomized, 
      controlled, double-blind study evaluated PCV20 and cPCV7 safety and 
      immunogenicity in healthy Japanese adults 18-49 years of age residing in the 
      United States for </=5 years. Participants (n = 104) were randomized equally to 
      receive a single dose of PCV20, cPCV7, or PCV13. Immunogenicity was assessed at 
      baseline and 1 month after vaccination using serotype-specific opsonophagocytic 
      activity (OPA) titers and serotype-specific immunoglobulin G (IgG) 
      concentrations. Prompted local reactions and systemic events; adverse events 
      (AEs); and serious AEs and newly diagnosed chronic disease were assessed 14 days, 
      through 1 month, and upto 6 months following vaccination, respectively. OPA 
      immune responses were robust for all 20 serotypes in the PCV20 group and for the 
      7 serotypes in the cPCV7 group 1 month after vaccination. IgG immune response 
      showed similar trends. Injection site pain and muscle pain were the most common 
      local reaction and systemic event; the majority were mild or moderate in 
      severity. Few AEs and no severe AEs, serious AEs, or safety-related withdrawals 
      were reported. Taken together, administration of PCV20 or cPCV7 in Japanese 
      adults was well tolerated and induced robust serotype-specific functional immune 
      responses. NCT03642847.
FAU - Fitz-Patrick, David
AU  - Fitz-Patrick D
AD  - East-West Medical Research Institute, Honolulu, HI, USA.
FAU - Young, Mariano Jr
AU  - Young M Jr
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.
FAU - Scott, Daniel A
AU  - Scott DA
AUID- ORCID: 0000-0002-4916-145X
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
AU  - Gruber W
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/NCT03642847
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20210205
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Pneumococcal Vaccines)
RN  - 0 (Vaccines, Conjugate)
SB  - IM
MH  - Adult
MH  - Antibodies, Bacterial
MH  - Child, Preschool
MH  - Humans
MH  - Japan
MH  - *Pneumococcal Infections/epidemiology/prevention & control
MH  - *Pneumococcal Vaccines/adverse effects
MH  - Serogroup
MH  - United States
MH  - Vaccines, Conjugate
PMC - PMC8189073
OTO - NOTNLM
OT  - PCV20
OT  - Streptococcus pneumoniae
OT  - cPCV7
OT  - clinical trial
OT  - immunogenicity
OT  - pneumococcal conjugate vaccine
OT  - safety
EDAT- 2021/02/06 06:00
MHDA- 2021/07/10 06:00
PMCR- 2021/02/05
CRDT- 2021/02/05 20:08
PHST- 2021/02/06 06:00 [pubmed]
PHST- 2021/07/10 06:00 [medline]
PHST- 2021/02/05 20:08 [entrez]
PHST- 2021/02/05 00:00 [pmc-release]
AID - 1863177 [pii]
AID - 10.1080/21645515.2020.1863177 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2021 Jul 3;17(7):2249-2256. doi: 
      10.1080/21645515.2020.1863177. Epub 2021 Feb 5.