PMID- 36641341
OWN - NLM
STAT- MEDLINE
DCOM- 20230228
LR  - 20230228
IS  - 2212-5353 (Electronic)
IS  - 2212-5345 (Linking)
VI  - 61
IP  - 2
DP  - 2023 Mar
TI  - Safety and immunogenicity of a respiratory syncytial virus prefusion F protein 
      (RSVPreF3) candidate vaccine in older Japanese adults: A phase I, randomized, 
      observer-blind clinical trial.
PG  - 261-269
LID - S2212-5345(22)00154-X [pii]
LID - 10.1016/j.resinv.2022.11.003 [doi]
AB  - BACKGROUND: Respiratory syncytial virus (RSV) causes lower respiratory tract 
      infection, with a high burden of disease among adults >/=60 years. This study 
      assessed the safety, reactogenicity, and immunogenicity of an investigational 
      adjuvanted RSV vaccine (RSVPreF3/AS01(B)) in Japanese adults aged 60-80 years. 
      METHODS: Forty participants were randomized to receive two doses of 
      RSVPreF3/AS01(B) or the placebo, in a 1:1 ratio, two months apart, in this 
      placebo-controlled study. Solicited administration-site and systemic adverse 
      events (AEs) were collected within 7 days and unsolicited AEs within 30 days 
      post-vaccination. Serious AEs (SAEs) and potential immune-mediated diseases 
      (pIMDs) were collected throughout the study (12 months post-dose 2). 
      RSVPreF3-specific immunoglobulin G (IgG) antibody concentrations and neutralizing 
      antibody (nAb) titers against RSV-A were evaluated on day (D)1, D31, D61, D91 and 
      those against RSV-B on D1, D31, D91. RESULTS: Solicited AEs were reported more 
      frequently in RSVPreF3/AS01(B) recipients (80.0%-90.0%) than in placebo 
      recipients (10.0%-20.0%). Two RSVPreF3/AS01(B) recipients experienced grade 3 
      solicited AEs. Rate of unsolicited AEs were similar (30.0%-35.0%) in both groups. 
      No RSVPreF3/AS01(B) recipient reported SAEs/pIMDs, while one placebo recipient 
      reported two SAEs that were unrelated to vaccination. Baseline RSVPreF3-specific 
      IgG and RSV-A/-B nAb levels were above the assay cut-off values. In the 
      RSVPreF3/AS01(B) group, RSVPreF3-specific IgG concentrations increased 12.8-fold 
      on D31 and 9.2-fold on D91 versus baseline while nAb titers increased 7.3-fold 
      (RSV-A) and 8.4-fold (RSV-B) on D31 and 6.3-fold (RSV-A) and 9.9-fold (RSV-B) on 
      D91. CONCLUSIONS: The RSVPreF3/AS01(B) vaccine was well tolerated and immunogenic 
      in older Japanese adults. CLINICAL TRIAL REGISTRATION NUMBER: NCT04090658.
CI  - Copyright (c) 2022 [The Author/The Authors]. Published by Elsevier B.V. All rights 
      reserved.
FAU - Kotb, Shady
AU  - Kotb S
AD  - GSK, Avenue Flemming 20, 1300 Wavre, Belgium. Electronic address: 
      shady.x.kotb@gsk.com.
FAU - Haranaka, Miwa
AU  - Haranaka M
AD  - SOUSEIKAI PS Clinic, Random Square 8th Fl, 6-18, Tenyamachi, Hakata-Ku, Fukuoka, 
      Japan.
FAU - Folschweiller, Nicolas
AU  - Folschweiller N
AD  - GSK, Avenue Flemming 20, 1300 Wavre, Belgium.
FAU - Nakanwagi, Phoebe
AU  - Nakanwagi P
AD  - GSK, Avenue Flemming 20, 1300 Wavre, Belgium.
FAU - Verheust, Celine
AU  - Verheust C
AD  - GSK, Avenue Flemming 20, 1300 Wavre, Belgium.
FAU - De Schrevel, Nathalie
AU  - De Schrevel N
AD  - GSK, Rue de L'Institut 89, 1330 Rixensart, Belgium.
FAU - David, Marie-Pierre
AU  - David MP
AD  - GSK, Avenue Flemming 20, 1300 Wavre, Belgium.
FAU - Mesaros, Narcisa
AU  - Mesaros N
AD  - GSK, Avenue Flemming 20, 1300 Wavre, Belgium.
FAU - Hulstrom, Veronica
AU  - Hulstrom V
AD  - GSK, Avenue Flemming 20, 1300 Wavre, Belgium.
LA  - eng
SI  - ClinicalTrials.gov/NCT04090658
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20230112
PL  - Netherlands
TA  - Respir Investig
JT  - Respiratory investigation
JID - 101581124
RN  - 0 (Antibodies, Viral)
RN  - 0 (Immunoglobulin G)
RN  - 0 (Respiratory Syncytial Virus Vaccines)
SB  - IM
MH  - Aged
MH  - Humans
MH  - Antibodies, Viral
MH  - East Asian People
MH  - Immunoglobulin G
MH  - *Respiratory Syncytial Virus Infections/prevention & control
MH  - *Respiratory Syncytial Virus Vaccines/immunology
MH  - Respiratory Syncytial Virus, Human
MH  - Middle Aged
MH  - Aged, 80 and over
MH  - *Immunogenicity, Vaccine
OTO - NOTNLM
OT  - Immunogenicity
OT  - Older adults
OT  - RSV vaccine
OT  - Respiratory syncytial virus
OT  - Safety
COIS- Conflict of interest SK, NF, PN, CV, NDeS, MPD, NM and VH are or were employees 
      of the GSK group of companies and declare financial and non-financial 
      relationships and activities. SK, CV, NDeS, MPD, NM and VH hold or held shares in 
      the GSK group of companies as part of their employee remuneration. MH has nothing 
      to disclose.
EDAT- 2023/01/15 06:00
MHDA- 2023/03/03 06:00
CRDT- 2023/01/14 22:04
PHST- 2022/06/21 00:00 [received]
PHST- 2022/10/05 00:00 [revised]
PHST- 2022/11/08 00:00 [accepted]
PHST- 2023/01/15 06:00 [pubmed]
PHST- 2023/03/03 06:00 [medline]
PHST- 2023/01/14 22:04 [entrez]
AID - S2212-5345(22)00154-X [pii]
AID - 10.1016/j.resinv.2022.11.003 [doi]
PST - ppublish
SO  - Respir Investig. 2023 Mar;61(2):261-269. doi: 10.1016/j.resinv.2022.11.003. Epub 
      2023 Jan 12.