PMID- 35146039
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220501
IS  - 2328-8957 (Print)
IS  - 2328-8957 (Electronic)
IS  - 2328-8957 (Linking)
VI  - 9
IP  - 3
DP  - 2022 Mar
TI  - Immunogenicity, Safety, and Tolerability of V114, a 15-Valent Pneumococcal 
      Conjugate Vaccine, in Immunocompetent Adults Aged 18-49 Years With or Without 
      Risk Factors for Pneumococcal Disease: A Randomized Phase 3 Trial (PNEU-DAY).
PG  - ofab605
LID - 10.1093/ofid/ofab605 [doi]
LID - ofab605
AB  - BACKGROUND: Adults with certain medical and behavioral factors are at increased 
      risk for pneumococcal disease (PD). Sequential vaccination with 13-valent 
      pneumococcal conjugate vaccine (PCV13) followed by 23-valent pneumococcal 
      polysaccharide vaccine (PPSV23) is recommended for at-risk adults in some 
      countries. METHODS: This phase 3 trial evaluated the safety, tolerability, and 
      immunogenicity of sequential administration of either V114 (a 15-valent PCV 
      containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 
      33F) or PCV13, followed 6 months later by PPSV23, in immunocompetent adults aged 
      18-49 years with or without predefined risk factors for PD (NCT03547167). 
      Overall, 1515 participants were randomized 3:1 to receive either V114 or PCV13, 
      followed by PPSV23. RESULTS: Most common solicited adverse events (AEs) following 
      administration of V114 or PCV13 as well as PPSV23 were injection-site pain and 
      fatigue. The proportion of participants with AEs was comparable in both groups. 
      V114 and PCV13 were immunogenic based on opsonophagocytic activity (OPA) 
      geometric mean titers (GMTs) 30 days postvaccination for all serotypes contained 
      in each respective vaccine. OPA GMTs to the 2 unique serotypes in V114 were 
      robust in the V114 group. PPSV23 was immunogenic for all 15 serotypes contained 
      in V114 in both vaccination groups, including 22F and 33F. CONCLUSIONS: V114 
      administered alone or sequentially with PPSV23 is well tolerated and immunogenic 
      for all 15 serotypes, including those not contained in PCV13, in immunocompetent 
      adults aged 18-49 years with or without certain medical or behavioral risk 
      factors for PD. CLINICAL TRIALS REGISTRATION: NCT03547167 and EudraCT 
      2017-004915-38.
CI  - (c) The Author(s) 2021. Published by Oxford University Press on behalf of 
      Infectious Diseases Society of America.
FAU - Hammitt, Laura L
AU  - Hammitt LL
AD  - Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
FAU - Quinn, Dean
AU  - Quinn D
AD  - P3 Research, Wellington Clinical Trial Research Unit, Wellington, New Zealand.
FAU - Janczewska, Ewa
AU  - Janczewska E
AD  - The School of Health Sciences in Bytom, Medical University of Silesia, Katowice, 
      Poland.
FAU - Pasquel, Francisco J
AU  - Pasquel FJ
AD  - Emory University School of Medicine, Atlanta, Georgia, USA.
FAU - Tytus, Richard
AU  - Tytus R
AD  - McMaster University, Ontario, Canada.
FAU - Rajender Reddy, K
AU  - Rajender Reddy K
AD  - Perelman School of Medicine, University of Pennsylvania, Philadelphia, 
      Pennsylvania, USA.
FAU - Abarca, Katia
AU  - Abarca K
AD  - Escuela de Medicina, Pontificia Universidad Catolica de Chile, Santiago, Chile.
FAU - Khaertynova, Ilsiyar M
AU  - Khaertynova IM
AD  - Department of Infectious Diseases, Kazan State Medical Academy, Kazan, Russia.
FAU - Dagan, Ron
AU  - Dagan R
AUID- ORCID: 0000-0002-8888-1046
AD  - Ben-Gurion University, Beer-Sheva, Israel.
FAU - McCauley, Jennifer
AU  - McCauley J
AD  - Merck & Co, Inc, Kenilworth, New Jersey, USA.
FAU - Cheon, Kyeongmi
AU  - Cheon K
AD  - Merck & Co, Inc, Kenilworth, New Jersey, USA.
FAU - Pedley, Alison
AU  - Pedley A
AD  - Merck & Co, Inc, Kenilworth, New Jersey, USA.
FAU - Sterling, Tina
AU  - Sterling T
AD  - Merck & Co, Inc, Kenilworth, New Jersey, USA.
FAU - Tamms, Gretchen
AU  - Tamms G
AD  - Merck & Co, Inc, Kenilworth, New Jersey, USA.
FAU - Musey, Luwy
AU  - Musey L
AUID- ORCID: 0000-0001-5484-7037
AD  - Merck & Co, Inc, Kenilworth, New Jersey, USA.
FAU - Buchwald, Ulrike K
AU  - Buchwald UK
AD  - Merck & Co, Inc, Kenilworth, New Jersey, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03547167
PT  - Journal Article
DEP - 20211218
PL  - United States
TA  - Open Forum Infect Dis
JT  - Open forum infectious diseases
JID - 101637045
PMC - PMC8826015
OTO - NOTNLM
OT  - *15-valent PCV
OT  - *PCV13
OT  - *PPSV23
OT  - *V114
OT  - *pneumococcal vaccine
EDAT- 2022/02/12 06:00
MHDA- 2022/02/12 06:01
PMCR- 2021/12/18
CRDT- 2022/02/11 05:42
PHST- 2021/09/01 00:00 [received]
PHST- 2021/12/16 00:00 [accepted]
PHST- 2022/02/11 05:42 [entrez]
PHST- 2022/02/12 06:00 [pubmed]
PHST- 2022/02/12 06:01 [medline]
PHST- 2021/12/18 00:00 [pmc-release]
AID - ofab605 [pii]
AID - 10.1093/ofid/ofab605 [doi]
PST - epublish
SO  - Open Forum Infect Dis. 2021 Dec 18;9(3):ofab605. doi: 10.1093/ofid/ofab605. 
      eCollection 2022 Mar.