PMID- 37389808
OWN - NLM
STAT- MEDLINE
DCOM- 20230703
LR  - 20231116
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 19
IP  - 2
DP  - 2023 Aug 1
TI  - Safety, tolerability, and immunogenicity of a 21-valent pneumococcal conjugate 
      vaccine, V116, in Japanese healthy adults: A Phase I study.
PG  - 2228162
LID - 10.1080/21645515.2023.2228162 [doi]
LID - 2228162
AB  - V116 is an investigational 21-valent pneumococcal conjugate vaccine (PCV) to 
      address the burden of residual adult pneumococcal disease after the introduction 
      of pediatric PCVs into national immunization programs (NIPs) and includes 
      serotypes highly prevalent in adult invasive pneumococcal disease (IPD). This 
      Phase I study assessed the safety, tolerability, and immunogenicity of V116 in 
      Japanese adults. Participants >/=20 years of age were randomized to receive a 
      single dose of V116 or 23-valent pneumococcal polysaccharide vaccine (PPSV23) at 
      day 1. Outcomes were solicited injection-site and systemic adverse events (AEs) 
      from day 1 to day 5, vaccine-related serious AEs from day 1 through day 30, and 
      serotype-specific opsonophagocytic antibody (OPA) titers and immunoglobulin G 
      (IgG) concentrations at day 30. Overall, 102 participants were randomized 1:1 to 
      each group. Comparable proportions vaccinated with V116 and PPSV23 experienced >/=1 
      solicited injection-site AE and >/=1 solicited systemic AE. The most common 
      injection-site AEs were injection-site pain (V116: 54.9%; PPSV23: 66.7%) and 
      swelling (V116 and PPSV23: 13.7%), and the most common systemic AEs were myalgia 
      (V116: 17.6%; PPSV23: 19.6%) and fatigue (V116: 13.7%; PPSV23: 9.8%). Solicited 
      AEs were mostly mild and of </=3 days duration. No vaccine-related serious AEs or 
      deaths were reported. The OPA and IgG findings showed that the immunogenicity of 
      V116 and PPSV23 were comparable for the 12 common serotypes and V116 was more 
      immunogenic for the nine unique serotypes compared with PPSV23. V116 was well 
      tolerated, with a safety profile similar to PPSV23, and induced functional 
      antibodies against all 21 serotypes.
FAU - Haranaka, Miwa
AU  - Haranaka M
AD  - Department of Internal Medicine, SOUSEIKAI PS Clinic, Fukuoka, Japan.
FAU - Yono, Makoto
AU  - Yono M
AD  - Department of Urology, Nishi-Kumamoto Hospital, Souseikai, Kumamoto, Japan.
FAU - Kishino, Hiroyuki
AU  - Kishino H
AD  - MSD K.K, Tokyo, Japan.
FAU - Igarashi, Rie
AU  - Igarashi R
AD  - MSD K.K, Tokyo, Japan.
FAU - Oshima, Nobuyuki
AU  - Oshima N
AD  - MSD K.K, Tokyo, Japan.
FAU - Sawata, Miyuki
AU  - Sawata M
AD  - MSD K.K, Tokyo, Japan.
FAU - Platt, Heather Loryn
AU  - Platt HL
AD  - Merck & Co., Inc., Rahway, NJ, USA.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Immunoglobulin G)
RN  - 0 (Vaccines, Conjugate)
RN  - 0 (Pneumococcal Vaccines)
SB  - IM
MH  - Adult
MH  - Humans
MH  - East Asian People
MH  - Fatigue
MH  - Immunoglobulin G
MH  - *Pneumococcal Infections/prevention & control
MH  - Vaccines, Conjugate/immunology
MH  - *Pneumococcal Vaccines/immunology
MH  - *Immunogenicity, Vaccine
PMC - PMC10316726
OTO - NOTNLM
OT  - 21-valent
OT  - Japanese
OT  - V116
OT  - adults
OT  - immunogenicity
OT  - pneumococcal conjugate vaccine
OT  - pneumococcal disease
OT  - safety
OT  - tolerability
COIS- H.P. is an employee of Merck & Co., Inc., Rahway, NJ, USA and may own stock 
      and/or stock options in Merck & Co., Inc., Rahway, NJ, USA. H.K., N.O., M.S., 
      R.I. are employees of MSD K.K., Tokyo, Japan and may own stock and/or stock 
      options in Merck & Co., Inc., Rahway, NJ, USA. M.H. and M.Y. have no conflicts of 
      interest to report.
EDAT- 2023/06/30 13:11
MHDA- 2023/07/03 06:42
PMCR- 2023/06/30
CRDT- 2023/06/30 11:13
PHST- 2023/07/03 06:42 [medline]
PHST- 2023/06/30 13:11 [pubmed]
PHST- 2023/06/30 11:13 [entrez]
PHST- 2023/06/30 00:00 [pmc-release]
AID - 2228162 [pii]
AID - 10.1080/21645515.2023.2228162 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2023 Aug 1;19(2):2228162. doi: 
      10.1080/21645515.2023.2228162.