Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial.
Journal
Nature microbiology
ISSN: 2058-5276
Titre abrégé: Nat Microbiol
Pays: England
ID NLM: 101674869
Informations de publication
Date de publication:
12 2022
12 2022
Historique:
received:
29
06
2022
accepted:
04
10
2022
pubmed:
11
11
2022
medline:
3
12
2022
entrez:
10
11
2022
Statut:
ppublish
Résumé
Measuring immune correlates of disease acquisition and protection in the context of a clinical trial is a prerequisite for improved vaccine design. We analysed binding and neutralizing antibody measurements 4 weeks post vaccination as correlates of risk of moderate to severe-critical COVID-19 through 83 d post vaccination in the phase 3, double-blind placebo-controlled phase of ENSEMBLE, an international randomized efficacy trial of a single dose of Ad26.COV2.S. We also evaluated correlates of protection in the trial cohort. Of the three antibody immune markers we measured, we found most support for 50% inhibitory dilution (ID
Identifiants
pubmed: 36357712
doi: 10.1038/s41564-022-01262-1
pii: 10.1038/s41564-022-01262-1
pmc: PMC10166187
mid: NIHMS1867012
doi:
Substances chimiques
Ad26COVS1
JT2NS6183B
ChAdOx1 nCoV-19
B5S3K2V0G8
2019-nCoV Vaccine mRNA-1273
EPK39PL4R4
Antibodies, Neutralizing
0
Banques de données
ClinicalTrials.gov
['NCT04505722']
Types de publication
Randomized Controlled Trial
Clinical Trial, Phase III
Journal Article
Research Support, N.I.H., Intramural
Research Support, U.S. Gov't, P.H.S.
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1996-2010Subventions
Organisme : NIH HHS
ID : S10 OD028685
Pays : United States
Organisme : CLC NIH HHS
ID : C0000008
Pays : United States
Organisme : ASPR HHS
ID : HHSO100201700018C
Pays : United States
Organisme : NIAID NIH HHS
ID : R37 AI054165
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068635
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068614
Pays : United States
Commentaires et corrections
Type : UpdateOf
Informations de copyright
© 2022. The Author(s), under exclusive licence to Springer Nature Limited.
Références
Vaccine. 2022 Jul 30;40(32):4403-4411
pubmed: 35667914
N Engl J Med. 2021 Jun 10;384(23):2187-2201
pubmed: 33882225
J Clin Microbiol. 2020 Oct 21;58(11):
pubmed: 32826322
Cell. 2021 Jun 24;184(13):3467-3473.e11
pubmed: 34133941
Nat Med. 2021 Sep;27(9):1493-1494
pubmed: 34518674
Clin Infect Dis. 2012 Jun;54(11):1615-7
pubmed: 22437237
N Engl J Med. 2021 Feb 11;384(6):533-540
pubmed: 33369366
Nature. 2021 Feb;590(7847):630-634
pubmed: 33276369
Science. 2022 Jan 07;375(6576):43-50
pubmed: 34812653
N Engl J Med. 2021 Feb 4;384(5):403-416
pubmed: 33378609
Ann Intern Med. 2017 Aug 15;167(4):268-274
pubmed: 28693043
N Engl J Med. 2022 Mar 3;386(9):847-860
pubmed: 35139271
Vaccine. 2021 Jul 22;39(32):4423-4428
pubmed: 34210573
Nat Med. 2021 Nov;27(11):2032-2040
pubmed: 34588689
N Engl J Med. 2021 Sep 2;385(10):951-953
pubmed: 34260834
N Engl J Med. 2021 Jan 14;384(2):e2
pubmed: 33264543
Nat Med. 2022 Apr;28(4):823-830
pubmed: 35145311
Biostatistics. 2022 Jul 15;:
pubmed: 35848843
Immunol Rev. 2022 Sep;310(1):6-26
pubmed: 35661178
Cell Rep Med. 2022 Jan 17;3(2):100510
pubmed: 35233544
Nat Med. 2021 Jul;27(7):1205-1211
pubmed: 34002089
Cell. 2022 Jul 7;185(14):2434-2451.e17
pubmed: 35764089
N Engl J Med. 2022 Jan 6;386(1):35-46
pubmed: 34752019
Science. 2021 Sep 17;373(6561):eabj0299
pubmed: 34529476
Open Forum Infect Dis. 2021 Dec 23;9(2):ofab632
pubmed: 35103246
Clin Vaccine Immunol. 2010 Jul;17(7):1055-65
pubmed: 20463105
Sci Rep. 2021 Dec 14;11(1):23921
pubmed: 34907214
Science. 2020 Aug 14;369(6505):806-811
pubmed: 32434945
N Engl J Med. 2021 Sep 23;385(13):1184-1195
pubmed: 34347950
Lancet Microbe. 2022 Jan;3(1):e52-e61
pubmed: 34806056
Nature. 2021 Aug;596(7871):268-272
pubmed: 34107529
Lancet. 2021 Mar 6;397(10277):881-891
pubmed: 33617777