A phase IIA extension study evaluating the effect of booster vaccination with a fractional dose of RTS,S/AS01
Booster
Controlled human malaria infection re-challenge
Efficacy
Fractional dose
Plasmodium falciparum malaria
RTS
S/AS01
Journal
Vaccine
ISSN: 1873-2518
Titre abrégé: Vaccine
Pays: Netherlands
ID NLM: 8406899
Informations de publication
Date de publication:
15 10 2021
15 10 2021
Historique:
received:
17
05
2021
revised:
06
09
2021
accepted:
07
09
2021
pubmed:
2
10
2021
medline:
26
10
2021
entrez:
1
10
2021
Statut:
ppublish
Résumé
We previously demonstrated that RTS,S/AS01 49 participants (P-Fx: 25; NP-Fx: 24) received a fractional (1/5th dose-volume) RTS,S/AS01 Overall vaccine efficacy against re-challenge was 53% (95% CI: 37-65%), and similar for P-Fx (52% [95% CI: 28-68%]) and NP-Fx (54% [95% CI: 29-70%]). Efficacy appeared unaffected by primary regimen or previous protection status. Anti-CS (repeat region) antibody geometric mean concentrations (GMCs) increased post-booster vaccination. GMCs were maintained over time in primary three-dose groups but declined in the two-dose group. Protection after re-challenge was associated with higher anti-CS antibody responses. The booster was well-tolerated. A fractional RTS,S/AS01 NCT03824236. linked to this article can be found on the Research Data as well as Figshare https://figshare.com/s/ee025150f9d1ac739361.
Sections du résumé
BACKGROUND
We previously demonstrated that RTS,S/AS01
METHODS
49 participants (P-Fx: 25; NP-Fx: 24) received a fractional (1/5th dose-volume) RTS,S/AS01
RESULTS
Overall vaccine efficacy against re-challenge was 53% (95% CI: 37-65%), and similar for P-Fx (52% [95% CI: 28-68%]) and NP-Fx (54% [95% CI: 29-70%]). Efficacy appeared unaffected by primary regimen or previous protection status. Anti-CS (repeat region) antibody geometric mean concentrations (GMCs) increased post-booster vaccination. GMCs were maintained over time in primary three-dose groups but declined in the two-dose group. Protection after re-challenge was associated with higher anti-CS antibody responses. The booster was well-tolerated.
CONCLUSIONS
A fractional RTS,S/AS01
CLINICAL TRIAL REGISTRATION
NCT03824236. linked to this article can be found on the Research Data as well as Figshare https://figshare.com/s/ee025150f9d1ac739361.
Identifiants
pubmed: 34593270
pii: S0264-410X(21)01203-2
doi: 10.1016/j.vaccine.2021.09.024
pii:
doi:
Substances chimiques
Antibodies, Protozoan
0
Malaria Vaccines
0
Banques de données
ClinicalTrials.gov
['NCT03824236']
Types de publication
Clinical Trial, Phase II
Journal Article
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
6398-6406Informations de copyright
Copyright © 2021 GlaxoSmithKline Biologicals S.A. Published by Elsevier Ltd.. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Lievens, Marc; Morelle, Danielle; Debois, Muriel and Ofori-Anyinam, Opokua; are employees of the GSK group of companies. Debois, Muriel; Morelle, Danielle; Lievens, Marc; Ofori-Anyinam, Opokua have restricted shares in the GSK group of companies. Greenleaf, Melissa; Duncan, Elizabeth; Chuang, Ilin; Angov, Evelina; Ivinson, Karen; Komisar, Jack; Lee, Cynthia; Moon, James; Ockenhouse, Christian; Regules, Jason; Garver, Lindsey; Sedegah, Martha; Sikaffy, April K; Ngauy, Viseth declare no competing interests.