PMID- 38133639
OWN - NLM
STAT- Publisher
LR  - 20231222
IS  - 1537-6613 (Electronic)
IS  - 0022-1899 (Linking)
DP  - 2023 Dec 22
TI  - Safety and Immunogenicity of Respiratory Syncytial Virus Pre-fusion Maternal 
      Vaccine Co-administered with Diphtheria-Tetanus-Pertussis Vaccine: A Phase 2 
      Study.
LID - jiad560 [pii]
LID - 10.1093/infdis/jiad560 [doi]
AB  - BACKGROUND: Respiratory syncytial virus (RSV) fusion protein stabilized in the 
      prefusion conformation (RSVPreF3) was under investigation as a maternal vaccine. 
      METHODS: This phase 2, randomized, placebo-controlled, single-dose, multicenter 
      study enrolled healthy, non-pregnant women, randomized 1:1:1:1:1 to five parallel 
      groups studying RSVPreF3 (60 or 120 microg) co-administered with diphtheria, tetanus, 
      and acellular pertussis vaccine (dTpa) or placebo, and dTpa co-administered with 
      placebo. Safety and humoral immune responses were assessed. An extension phase 
      also assessed a RSVPreF3 120 mug vaccination 12-18 months post-first vaccination. 
      RESULTS: The safety profile of RSVPreF3 was unaffected by dose or dTpa 
      co-administration. Solicited and unsolicited adverse events (AEs) were evenly 
      distributed across study groups. Injection-site pain was higher following the 
      second vaccination vs the first vaccination. Medically attended AEs were rare 
      (<5% overall). Both RSVPreF3 dose levels (alone and with dTpa) were immunogenic, 
      increasing levels of RSV-A neutralizing antibody >/=8 fold and anti-RSVPreF3 IgG 
      antibody >/=11 fold at 1 month post-vaccination, which persisted at 12-18 months 
      post-vaccination; modest 2-fold increases were observed with a second RSVPreF3 
      vaccination. CONCLUSIONS: This study indicates RSVPreF3 co-administration with 
      dTpa induces robust immune responses and is well tolerated, regardless of the 
      RSVPreF3 dose level used. CLINICAL TRIALS REGISTRATION: NCT04138056.
CI  - (c) The Author(s) 2023. Published by Oxford University Press on behalf of 
      Infectious Diseases Society of America.
FAU - Hermida, Nerea
AU  - Hermida N
AUID- ORCID: 0009-0008-7445-6381
AD  - GSK Vaccines, Clinical Research Development, 1300 Wavre, Belgium.
FAU - Ferguson, Murdo
AU  - Ferguson M
AD  - Colchester Research Group, Department of Family Medicine and Emergency Medicine, 
      Truro, NS B2N 1L2, Canada.
FAU - Leroux-Roels, Isabel
AU  - Leroux-Roels I
AD  - Center for Vaccinology (CEVAC), Ghent University and Ghent University Hospital, 
      9000 Ghent, Belgium.
FAU - Pagnussat, Sandra
AU  - Pagnussat S
AD  - Miami Research Associates, Miami, FL, 33143, USA.
FAU - Yaplee, Deborah
AU  - Yaplee D
AD  - GSK Vaccines, Vaccine Development, Rockville, MD, 20850, USA.
FAU - Hua, Nancy
AU  - Hua N
AD  - GSK Vaccines, Vaccine Development, Rockville, MD, 20850, USA.
FAU - Van den Steen, Peter
AU  - Van den Steen P
AD  - GSK Vaccines, Clinical Research Development, 1300 Wavre, Belgium.
FAU - Anspach, Bruno
AU  - Anspach B
AD  - GSK Vaccines, Vaccine Development, Rockville, MD, 20850, USA.
FAU - Dieussaert, Ilse
AU  - Dieussaert I
AD  - GSK Vaccines, Clinical Research Development, 1300 Wavre, Belgium.
FAU - Kim, Joon Hyung
AU  - Kim JH
AD  - GSK Vaccines, Vaccine Development, Rockville, MD, 20850, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT04138056
PT  - Journal Article
DEP - 20231222
PL  - United States
TA  - J Infect Dis
JT  - The Journal of infectious diseases
JID - 0413675
SB  - IM
OTO - NOTNLM
OT  - RSV vaccine
OT  - Respiratory syncytial virus
OT  - co-administration
OT  - dTpa vaccine
OT  - immunogenicity
OT  - maternal vaccine
OT  - safety
EDAT- 2023/12/22 12:41
MHDA- 2023/12/22 12:41
CRDT- 2023/12/22 10:53
PHST- 2023/05/17 00:00 [received]
PHST- 2023/11/14 00:00 [revised]
PHST- 2023/12/04 00:00 [accepted]
PHST- 2023/12/22 12:41 [medline]
PHST- 2023/12/22 12:41 [pubmed]
PHST- 2023/12/22 10:53 [entrez]
AID - 7491175 [pii]
AID - 10.1093/infdis/jiad560 [doi]
PST - aheadofprint
SO  - J Infect Dis. 2023 Dec 22:jiad560. doi: 10.1093/infdis/jiad560.