Genotypic analysis of RTS,S/AS01


Journal

The Lancet. Infectious diseases
ISSN: 1474-4457
Titre abrégé: Lancet Infect Dis
Pays: United States
ID NLM: 101130150

Informations de publication

Date de publication:
06 May 2024
Historique:
received: 26 01 2024
revised: 07 03 2024
accepted: 08 03 2024
medline: 10 5 2024
pubmed: 10 5 2024
entrez: 9 5 2024
Statut: aheadofprint

Résumé

The first licensed malaria vaccine, RTS,S/AS01 Between Sept 28, 2017, and Sept 25, 2018, 1500 children aged 5-17 months were randomly assigned (1:1:1:1:1) to receive four different RTS,S/AS01 We observed significant and similar vaccine efficacy (25-43%; 95% CI union 9-53) against first new infection for all four RTS,S/AS01 All tested dosing regimens blocked some infections to a similar degree. Improved vaccine efficacy in participants infected during vaccination could suggest new strategies for highly efficacious malaria vaccine development and implementation. GlaxoSmithKline Biologicals SA, PATH, Bill & Melinda Gates Foundation, and the German Federal Ministry of Education and Research.

Sections du résumé

BACKGROUND BACKGROUND
The first licensed malaria vaccine, RTS,S/AS01
METHODS METHODS
Between Sept 28, 2017, and Sept 25, 2018, 1500 children aged 5-17 months were randomly assigned (1:1:1:1:1) to receive four different RTS,S/AS01
FINDINGS RESULTS
We observed significant and similar vaccine efficacy (25-43%; 95% CI union 9-53) against first new infection for all four RTS,S/AS01
INTERPRETATION CONCLUSIONS
All tested dosing regimens blocked some infections to a similar degree. Improved vaccine efficacy in participants infected during vaccination could suggest new strategies for highly efficacious malaria vaccine development and implementation.
FUNDING BACKGROUND
GlaxoSmithKline Biologicals SA, PATH, Bill & Melinda Gates Foundation, and the German Federal Ministry of Education and Research.

Identifiants

pubmed: 38723650
pii: S1473-3099(24)00179-8
doi: 10.1016/S1473-3099(24)00179-8
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT03281291']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of interests The findings and conclusions in this article are those of the authors and do not necessarily represent the views of the US Centers for Disease Control and Prevention or the US Department of Health and Human Services. LDM received grants from the Bill and Melinda Gates Foundation and the German Federal Ministry of Education and Research through the KfW Development Bank through her institution. CKL received a grant from the German Federal Ministry of Education and Research through the KfW Development Bank and a grant from the Bill and Melinda Gates Foundation. DFW acted as a principal investigator on the MAL-095 study funded by a PATH grant paid to Harvard University, which also supported DEN, AME, BLM, SFS, and AK. DFW is also Chair of the Malaria Policy Advisory Group that advises the WHO on all malaria policy. PBG discloses a PATH subaward from Harvard for statistical analysis contributing to salary support for PBG, MJ, and LL. AME, LL, AK, BS, NSH, DB, SaA, TA, ScA, DA, DKB, PBYB, SE, NF, JG, SKK, KO, AMS, NW, and CFO declare no conflict of interest. ML, FR, OO-A are employees of GSK. ML, FR, and OO-A own shares in GSK.

Auteurs

Michal Juraska (M)

Fred Hutchinson Cancer Center, Vaccine and Infectious Disease Division, Seattle, WA, USA. Electronic address: mjuraska@fredhutch.org.

Angela M Early (AM)

Broad Institute, Infectious Disease and Microbiome Program, Cambridge, MA, USA.

Li Li (L)

Fred Hutchinson Cancer Center, Vaccine and Infectious Disease Division, Seattle, WA, USA.

Stephen F Schaffner (SF)

Broad Institute, Infectious Disease and Microbiome Program, Cambridge, MA, USA.

Marc Lievens (M)

GSK, Wavre, Belgium.

Akanksha Khorgade (A)

Broad Institute, Infectious Disease and Microbiome Program, Cambridge, MA, USA.

Brian Simpkins (B)

Fred Hutchinson Cancer Center, Vaccine and Infectious Disease Division, Seattle, WA, USA.

Nima S Hejazi (NS)

Harvard T.H. Chan School of Public Health, Department of Biostatistics, Boston, MA, USA.

David Benkeser (D)

Emory University Rollins School of Public Health, Department of Biostatistics and Bioinformatic, Atlanta, GA, USA.

Qi Wang (Q)

Department of Statistics, University of Washington, Seattle, WA, USA.

Laina D Mercer (LD)

PATH, Seattle, WA, USA.

Samuel Adjei (S)

Kwame Nkrumah University of Science and Technology/Agogo Presbyterian Hospital, Agogo, Asante Akyem, Ghana.

Tsiri Agbenyega (T)

Kwame Nkrumah University of Science and Technology/Agogo Presbyterian Hospital, Agogo, Asante Akyem, Ghana.

Scott Anderson (S)

Broad Institute, Infectious Disease and Microbiome Program, Cambridge, MA, USA.

Daniel Ansong (D)

Kwame Nkrumah University of Science and Technology/Agogo Presbyterian Hospital, Agogo, Asante Akyem, Ghana.

Dennis K Bii (DK)

Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.

Patrick B Y Buabeng (PBY)

Kwame Nkrumah University of Science and Technology/Agogo Presbyterian Hospital, Agogo, Asante Akyem, Ghana.

Sean English (S)

Broad Institute, Infectious Disease and Microbiome Program, Cambridge, MA, USA.

Nicholas Fitzgerald (N)

Broad Institute, Infectious Disease and Microbiome Program, Cambridge, MA, USA.

Jonna Grimsby (J)

Broad Institute, Infectious Disease and Microbiome Program, Cambridge, MA, USA.

Simon K Kariuki (SK)

Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.

Kephas Otieno (K)

Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.

François Roman (F)

GSK, Wavre, Belgium.

Aaron M Samuels (AM)

Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Kisumu, Kenya; Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.

Nelli Westercamp (N)

Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.

Christian F Ockenhouse (CF)

PATH, Seattle, WA, USA.

Opokua Ofori-Anyinam (O)

GSK, Wavre, Belgium.

Cynthia K Lee (CK)

PATH, Seattle, WA, USA.

Bronwyn L MacInnis (BL)

Broad Institute, Infectious Disease and Microbiome Program, Cambridge, MA, USA.

Dyann F Wirth (DF)

Broad Institute, Infectious Disease and Microbiome Program, Cambridge, MA, USA; Harvard T.H. Chan School of Public Health, Department of Immunology and Infectious Diseases, Boston, MA, USA.

Peter B Gilbert (PB)

Fred Hutchinson Cancer Center, Vaccine and Infectious Disease Division, Seattle, WA, USA; Department of Biostatistics, University of Washington, Hans Rosling Center for Population Health, Seattle, WA, USA.

Daniel E Neafsey (DE)

Broad Institute, Infectious Disease and Microbiome Program, Cambridge, MA, USA; Harvard T.H. Chan School of Public Health, Department of Immunology and Infectious Diseases, Boston, MA, USA. Electronic address: neafsey@hsph.harvard.edu.

Classifications MeSH