Subcutaneous Administration of a Monoclonal Antibody to Prevent Malaria.
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
26 Apr 2024
26 Apr 2024
Historique:
medline:
26
4
2024
pubmed:
26
4
2024
entrez:
26
4
2024
Statut:
aheadofprint
Résumé
Subcutaneous administration of the monoclonal antibody L9LS protected adults against controlled We conducted a phase 2 trial in Mali to assess the safety and efficacy of subcutaneous administration of L9LS in children 6 to 10 years of age over a 6-month malaria season. In part A of the trial, safety was assessed at three dose levels in adults, followed by assessment at two dose levels in children. In part B of the trial, children were randomly assigned, in a 1:1:1 ratio, to receive 150 mg of L9LS, 300 mg of L9LS, or placebo. The primary efficacy end point, assessed in a time-to-event analysis, was the first No safety concerns were identified in the dose-escalation part of the trial (part A). In part B, 225 children underwent randomization, with 75 children assigned to each group. No safety concerns were identified in part B. Subcutaneous administration of L9LS to children was protective against
Sections du résumé
BACKGROUND
BACKGROUND
Subcutaneous administration of the monoclonal antibody L9LS protected adults against controlled
METHODS
METHODS
We conducted a phase 2 trial in Mali to assess the safety and efficacy of subcutaneous administration of L9LS in children 6 to 10 years of age over a 6-month malaria season. In part A of the trial, safety was assessed at three dose levels in adults, followed by assessment at two dose levels in children. In part B of the trial, children were randomly assigned, in a 1:1:1 ratio, to receive 150 mg of L9LS, 300 mg of L9LS, or placebo. The primary efficacy end point, assessed in a time-to-event analysis, was the first
RESULTS
RESULTS
No safety concerns were identified in the dose-escalation part of the trial (part A). In part B, 225 children underwent randomization, with 75 children assigned to each group. No safety concerns were identified in part B.
CONCLUSIONS
CONCLUSIONS
Subcutaneous administration of L9LS to children was protective against
Identifiants
pubmed: 38669354
doi: 10.1056/NEJMoa2312775
doi:
Banques de données
ClinicalTrials.gov
['NCT05304611']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Investigateurs
Lassine Camara
(L)
Makan Camara
(M)
Sadio Coulibaly
(S)
Youssouf Dembélé
(Y)
Dramane Diakite
(D)
Oumar Diakite
(O)
Djelika Diarra
(D)
Mamadou Diarra
(M)
Famoussa Doumbia
(F)
Balla Fofana
(B)
Bintou Kassogue
(B)
Mohamed S Keita
(MS)
Bakary Konare
(B)
Brehima Konare
(B)
Mamadou Konare
(M)
Yacouba Konare
(Y)
Cheick Omar
(C)
Konate Mamoudou
(K)
Konate Ahmadou
(K)
M'Barakou Papa
(M)
Magatte N'diaye
(M)
Moussa I Ouologuem
(MI)
Samba Sacko
(S)
Aboubacar Andre Pascal Somboro
(AAP)
Mamadou Sylla
(M)
Robin Carroll
(R)
Mike Castro
(M)
Yogita Jethmalani
(Y)
Rachel Kazmierski
(R)
Kwang Low
(K)
Ashly E Lukoskie
(AE)
Madeeha Mughal
(M)
Daniel Saez
(D)
Lu Wang
(L)
Katrina Kelley
(K)
Cheyenne Knox
(C)
Ming Chang
(M)
Chris Chavtur
(C)
Annette Seilie
(A)
Weston Staubus
(W)
Kanwaldeep Bajwa
(K)
Michael Holdsworth
(M)
Harish Kandaswamay
(H)
Diane Rock Kress
(DR)
Mariam Namawejje
(M)
Pengchong Tang
(P)
Michael Tartakovsky
(M)
Christopher Whalen
(C)
Jennifer Xiao
(J)
Molly Buehn
(M)
Shelley Francella
(S)
Neelam Gulati
(N)
Liam Harmon
(L)
Shirley Jankelevich
(S)
Yvonne Jato
(Y)
Aaren King
(A)
Stacy Kopka
(S)
Mark Miller
(M)
Tracey Miller
(T)
Valerie Opher
(V)
Shelly Simpson
(S)
Marc Teitelbaum
(M)
John Tierney
(J)
Susan Vogel
(S)
Saran Wells
(S)
Kristin Young
(K)
Informations de copyright
Copyright © 2024 Massachusetts Medical Society.