Safety and Efficacy of a Monoclonal Antibody against Malaria in Mali.
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:
17 Nov 2022
17 Nov 2022
Historique:
pubmed:
2
11
2022
medline:
19
11
2022
entrez:
1
11
2022
Statut:
ppublish
Résumé
CIS43LS is a monoclonal antibody that was shown to protect against controlled We conducted a phase 2 trial to assess the safety and efficacy of a single intravenous infusion of CIS43LS against In Part B, 330 adults underwent randomization; 110 were assigned to each trial group. The risk of moderate headache was 3.3 times as high with 40 mg of CIS43LS per kilogram as with placebo. CIS43LS was protective against
Sections du résumé
BACKGROUND
CIS43LS is a monoclonal antibody that was shown to protect against controlled
METHODS
We conducted a phase 2 trial to assess the safety and efficacy of a single intravenous infusion of CIS43LS against
RESULTS
In Part B, 330 adults underwent randomization; 110 were assigned to each trial group. The risk of moderate headache was 3.3 times as high with 40 mg of CIS43LS per kilogram as with placebo.
CONCLUSIONS
CIS43LS was protective against
Identifiants
pubmed: 36317783
doi: 10.1056/NEJMoa2206966
pmc: PMC9881676
mid: NIHMS1853297
doi:
Substances chimiques
Antimalarials
0
Artemether, Lumefantrine Drug Combination
0
CIS43LS
0
Antibodies, Monoclonal, Humanized
0
Banques de données
ClinicalTrials.gov
['NCT04329104']
Types de publication
Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Intramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
1833-1842Subventions
Organisme : Intramural NIH HHS
ID : Z99 AI999999
Pays : United States
Investigateurs
Dramane Diakite
(D)
Issa Kalossi
(I)
Mohamed Keita
(M)
Aboubacar Andre Pascal Somboro
(AAP)
Mamadou Sylla
(M)
Souleymane Traore
(S)
Ahmadou M'Barakou
(A)
Balla Fofana
(B)
Samba Sacko
(S)
Mamoudou Konate
(M)
Ali Togara
(A)
Lassana Traore
(L)
Lassina K Traore
(LK)
Djelika Diarra
(D)
Mamadou Diarra
(M)
Bintou Kassogue
(B)
Brehima Konare
(B)
Mamadou Konare
(M)
Bakary Konare
(B)
Cheick Omar Konate
(CO)
Hady Oumar Togora
(HO)
Famoussa Doumbia
(F)
Yacouba Konare
(Y)
Sadio Coulibaly
(S)
Will Adams
(W)
Brandi France
(B)
C J Poole
(CJ)
Kanwaldeep Bajwa
(K)
Laxmi Buyyani
(L)
Telsa De Lange
(T)
Michael Duvenhage
(M)
Diane Rock Kress
(DR)
Mariam Namawejje
(M)
Pengchong Tang
(P)
Michael Tartakovsky
(M)
Christopher Whalen
(C)
Jennifer Xiao
(J)
Abby Balde
(A)
Molly Buehn
(M)
Kelly Cahill
(K)
Shelley Francella
(S)
Sadie Frary
(S)
Neelam Gulati
(N)
Liam Harmon
(L)
Shirley Jankelevich
(S)
Stacy Kopka
(S)
Katelyn Le
(K)
Tracey Miller
(T)
Valerie Opher
(V)
Shelly Simpson
(S)
Marc Teitelbaum
(M)
Kristin Young
(K)
Kassoum Kayentao
(K)
Aissata Ongoiba
(A)
Anne C Preston
(AC)
Sara A Healy
(SA)
Safiatou Doumbo
(S)
Didier Doumtabe
(D)
Shinyi Telscher
(S)
Azza H Idris
(AH)
Neville K Kisalu
(NK)
Kevin Carlton
(K)
Adrian B McDermott
(AB)
Martin Gaudinski
(M)
Zonghui Hu
(Z)
Amatigué Zéguimé
(A)
Amagana Dolo
(A)
Abdoulaye Djimdé
(A)
Boubacar Traore
(B)
Robert A Seder
(RA)
Peter D Crompton
(PD)
Abdrahamane Traore
(A)
Hamadi Traore
(H)
Adama Djiguiba
(A)
Shanping Li
(S)
Mary E Peterson
(ME)
Leonid Serebryannyy
(L)
Sandeep Narpala
(S)
Siriman Traore
(S)
Hamidou Cisse
(H)
Mamadou Keita
(M)
Adama Ouattara
(A)
M'Bouye Doucoure
(M)
Jeff Skinner
(J)
Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2022 Massachusetts Medical Society.
Références
Lancet Infect Dis. 2022 Dec;22(12):1728-1736
pubmed: 36087586
Clin Infect Dis. 2005 Jul 15;41(2):255-9
pubmed: 15983925
Clin Infect Dis. 2013 Jul;57(1):40-7
pubmed: 23487390
Trends Parasitol. 2016 Mar;32(3):187-196
pubmed: 26826784
N Engl J Med. 2021 Aug 26;385(9):803-814
pubmed: 34379916
Lancet Infect Dis. 2019 May;19(5):546-556
pubmed: 30922818
Arch Intern Med. 2000 Sep 11;160(16):2505-10
pubmed: 10979063
Immunity. 2020 Oct 13;53(4):733-744.e8
pubmed: 32946741
JCI Insight. 2021 Feb 8;6(3):
pubmed: 33332286
Lancet. 2001 Dec 8;358(9297):1927-34
pubmed: 11747915
Nat Med. 2020 Dec;26(12):1929-1940
pubmed: 33106664
Lancet. 2020 Dec 5;396(10265):1829-1840
pubmed: 33278936
N Engl J Med. 2022 Aug 4;387(5):397-407
pubmed: 35921449
Malar J. 2022 Mar 24;21(1):104
pubmed: 35331231
Am J Med Sci. 1991 Dec;302(6):374-9
pubmed: 1772123
PLoS One. 2009 Jul 31;4(7):e6465
pubmed: 19649245
Lancet Infect Dis. 2022 Mar;22(3):377-389
pubmed: 34801112
N Engl J Med. 2021 Sep 9;385(11):1005-1017
pubmed: 34432975
Lancet. 2004 Oct 16-22;364(9443):1411-20
pubmed: 15488216
Nat Med. 2018 May;24(4):408-416
pubmed: 29554083
N Engl J Med. 2021 Sep 23;385(13):1163-1171
pubmed: 34551228
Lancet. 2015 Jul 4;386(9988):31-45
pubmed: 25913272