PMID- 34146100
OWN - NLM
STAT- MEDLINE
DCOM- 20220617
LR  - 20220716
IS  - 1537-6613 (Electronic)
IS  - 0022-1899 (Print)
IS  - 0022-1899 (Linking)
VI  - 225
IP  - 12
DP  - 2022 Jun 15
TI  - Three Dose Levels of a Maternal Respiratory Syncytial Virus Vaccine Candidate Are 
      Well Tolerated and Immunogenic in a Randomized Trial in Nonpregnant Women.
PG  - 2067-2076
LID - 10.1093/infdis/jiab317 [doi]
AB  - BACKGROUND: Respiratory syncytial virus (RSV) causes respiratory tract 
      infections, which may require hospitalization especially in early infancy. 
      Transplacental transfer of RSV antibodies could confer protection to infants in 
      their first months of life. METHODS: In this first-in-human, placebo-controlled 
      study, 502 healthy nonpregnant women were randomized 1:1:1:1 to receive a single 
      dose of unadjuvanted vaccine containing 30/60/120 microg of RSV fusion (F) protein 
      stabilized in the prefusion conformation (RSVPreF3) or placebo. RESULTS: 
      Solicited local adverse events (AEs) were more frequently reported in the 
      RSVPreF3 groups (4%-53.2%) versus placebo (0%-15.9%); most were mild/moderate. 
      Unsolicited AEs were comparably reported among groups. Three serious AEs were 
      reported; none was vaccination-related. Compared with prevaccination values, 
      anti-RSV A neutralizing antibody geometric mean titers and anti-RSVPreF3 
      immunoglobulin G geometric mean concentrations increased 8- to 14-fold and 12- to 
      21-fold at day 8 and persisted 5- to 6-fold and 6- to 8-fold higher until day 91 
      in the RSVPreF3 groups versus 1-fold in placebo. Comparisons at day 8 and day 31 
      showed that the higher dose levels were significantly more immunogenic than the 
      lowest one. CONCLUSIONS: The RSVPreF3 vaccine was well tolerated and immunogenic. 
      The 60 and 120 microg dose levels were selected for further investigation in pregnant 
      women. CLINICAL TRIALS REGISTRATION: NCT03674177.
CI  - (c) The Author(s) 2021. Published by Oxford University Press for the Infectious 
      Diseases Society of America.
FAU - Schwarz, Tino F
AU  - Schwarz TF
AD  - Institute of Laboratory Medicine and Vaccination Centre, Klinikum Wurzburg Mitte, 
      Campus Juliusspital, Wurzburg, Germany.
FAU - Johnson, Casey
AU  - Johnson C
AD  - Johnson County Clin-Trials, Lenexa, Kansas, USA.
FAU - Grigat, Christine
AU  - Grigat C
AD  - Clinical Research Hamburg, Hamburg, Germany.
FAU - Apter, Dan
AU  - Apter D
AD  - VL-Medi, Helsinki, Finland.
FAU - Csonka, Peter
AU  - Csonka P
AD  - Centre for Child Health Research, Tampere University, Tampere, Finland.
FAU - Lindblad, Niklas
AU  - Lindblad N
AD  - Terveystalo Turku Vaccine Clinic, Turku, Finland.
FAU - Nguyen, Thi Lien-Anh
AU  - Nguyen TL
AD  - GSK, Wavre, Belgium.
FAU - Gao, Feng F
AU  - Gao FF
AD  - GSK, Rockville, Maryland, USA.
FAU - Qian, Hui
AU  - Qian H
AD  - GSK, Rockville, Maryland, USA.
FAU - Tullio, Antonella N
AU  - Tullio AN
AD  - GSK, Rockville, Maryland, USA.
FAU - Dieussaert, Ilse
AU  - Dieussaert I
AD  - GSK, Rockville, Maryland, USA.
FAU - Picciolato, Marta
AU  - Picciolato M
AD  - GSK, Rixensart, Belgium.
FAU - Henry, Ouzama
AU  - Henry O
AD  - GSK, Rockville, Maryland, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03674177
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Infect Dis
JT  - The Journal of infectious diseases
JID - 0413675
RN  - 0 (Antibodies, Neutralizing)
RN  - 0 (Antibodies, Viral)
RN  - 0 (Respiratory Syncytial Virus Vaccines)
RN  - 0 (Viral Fusion Proteins)
SB  - IM
MH  - Antibodies, Neutralizing
MH  - Antibodies, Viral
MH  - Female
MH  - Humans
MH  - Infant
MH  - Pregnancy
MH  - *Respiratory Syncytial Virus Infections
MH  - *Respiratory Syncytial Virus Vaccines
MH  - *Respiratory Syncytial Virus, Human
MH  - Viral Fusion Proteins
PMC - PMC9200160
OTO - NOTNLM
OT  - RSV
OT  - RSV vaccine
OT  - immunogenicity
OT  - maternal vaccine
OT  - nonpregnant women
OT  - respiratory syncytial virus
OT  - safety
OT  - vaccination
EDAT- 2021/06/20 06:00
MHDA- 2022/06/18 06:00
PMCR- 2021/06/19
CRDT- 2021/06/19 12:06
PHST- 2021/02/24 00:00 [received]
PHST- 2021/06/29 00:00 [accepted]
PHST- 2021/06/20 06:00 [pubmed]
PHST- 2022/06/18 06:00 [medline]
PHST- 2021/06/19 12:06 [entrez]
PHST- 2021/06/19 00:00 [pmc-release]
AID - 6306104 [pii]
AID - jiab317 [pii]
AID - 10.1093/infdis/jiab317 [doi]
PST - ppublish
SO  - J Infect Dis. 2022 Jun 15;225(12):2067-2076. doi: 10.1093/infdis/jiab317.