Immune correlates analysis of a phase 3 trial of the AZD1222 (ChAdOx1 nCoV-19) vaccine.
Journal
NPJ vaccines
ISSN: 2059-0105
Titre abrégé: NPJ Vaccines
Pays: England
ID NLM: 101699863
Informations de publication
Date de publication:
11 Mar 2023
11 Mar 2023
Historique:
received:
09
10
2022
accepted:
20
02
2023
entrez:
10
3
2023
pubmed:
11
3
2023
medline:
11
3
2023
Statut:
epublish
Résumé
In the phase 3 trial of the AZD1222 (ChAdOx1 nCoV-19) vaccine conducted in the U.S., Chile, and Peru, anti-spike binding IgG concentration (spike IgG) and pseudovirus 50% neutralizing antibody titer (nAb ID50) measured four weeks after two doses were assessed as correlates of risk and protection against PCR-confirmed symptomatic SARS-CoV-2 infection (COVID-19). These analyses of SARS-CoV-2 negative participants were based on case-cohort sampling of vaccine recipients (33 COVID-19 cases by 4 months post dose two, 463 non-cases). The adjusted hazard ratio of COVID-19 was 0.32 (95% CI: 0.14, 0.76) per 10-fold increase in spike IgG concentration and 0.28 (0.10, 0.77) per 10-fold increase in nAb ID50 titer. At nAb ID50 below the limit of detection (< 2.612 IU50/ml), 10, 100, and 270 IU50/ml, vaccine efficacy was -5.8% (-651%, 75.6%), 64.9% (56.4%, 86.9%), 90.0% (55.8%, 97.6%) and 94.2% (69.4%, 99.1%). These findings provide further evidence towards defining an immune marker correlate of protection to help guide regulatory/approval decisions for COVID-19 vaccines.
Identifiants
pubmed: 36899062
doi: 10.1038/s41541-023-00630-0
pii: 10.1038/s41541-023-00630-0
pmc: PMC10005913
doi:
Types de publication
Journal Article
Langues
eng
Pagination
36Subventions
Organisme : NIAID NIH HHS
ID : UM1 AI148450
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI069470
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069470
Pays : United States
Organisme : NIAID NIH HHS
ID : R37 AI054165
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI148684
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068635
Pays : United States
Informations de copyright
© 2023. The Author(s).
Références
Lancet. 2021 Dec 18;398(10318):2258-2276
pubmed: 34863358
J Clin Microbiol. 2020 Oct 21;58(11):
pubmed: 32826322
Lancet Respir Med. 2022 Jun;10(6):557-565
pubmed: 35227415
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 Jan 14;384(2):e2
pubmed: 33264543
Nature. 2021 Feb;590(7847):630-634
pubmed: 33276369
Cell. 2022 Jul 7;185(14):2434-2451.e17
pubmed: 35764089
Science. 2021 Sep 17;373(6561):eabj0299
pubmed: 34529476
Lancet. 2021 Mar 6;397(10277):881-891
pubmed: 33617777
Nat Med. 2021 Nov;27(11):2032-2040
pubmed: 34588689
BMC Infect Dis. 2022 May 7;22(1):439
pubmed: 35525973
Infection. 2022 Sep 15;:
pubmed: 36109464
Nat Microbiol. 2022 Dec;7(12):1996-2010
pubmed: 36357712
Biometrics. 2022 May 8;:
pubmed: 35526218
Lancet. 2021 Jan 9;397(10269):99-111
pubmed: 33306989
N Engl J Med. 2021 Jun 10;384(23):2187-2201
pubmed: 33882225
Lancet. 2020 Aug 15;396(10249):467-478
pubmed: 32702298
Lancet. 2022 Mar 5;399(10328):924-944
pubmed: 35202601
Emerg Infect Dis. 2023 Feb;29(2):381-388
pubmed: 36692375
N Engl J Med. 2021 Feb 11;384(6):533-540
pubmed: 33369366
Nat Commun. 2023 Jan 19;14(1):331
pubmed: 36658109
Lancet. 2021 Apr 10;397(10282):1347-1348
pubmed: 33770519
Bioinformatics. 2018 Dec 1;34(23):4121-4123
pubmed: 29790939
Science. 2022 Jan 07;375(6576):43-50
pubmed: 34812653
N Engl J Med. 2021 Feb 4;384(5):403-416
pubmed: 33378609
N Engl J Med. 2021 Dec 16;385(25):2348-2360
pubmed: 34587382
Biostatistics. 2022 Jul 15;:
pubmed: 35848843
Immunol Rev. 2022 Sep;310(1):6-26
pubmed: 35661178
Clin Vaccine Immunol. 2010 Jul;17(7):1055-65
pubmed: 20463105
Cell Rep Med. 2021 Sep 21;2(9):100405
pubmed: 34485950
Sci Rep. 2021 Dec 14;11(1):23921
pubmed: 34907214
J Clin Invest. 2022 Sep 15;132(18):
pubmed: 36106642
Lancet Microbe. 2022 Jan;3(1):e52-e61
pubmed: 34806056
Front Immunol. 2022 Aug 24;13:940562
pubmed: 36091023
N Engl J Med. 2021 Sep 23;385(13):1184-1195
pubmed: 34347950
Vaccine. 2021 Jul 22;39(32):4423-4428
pubmed: 34210573
Lancet. 2021 Apr 10;397(10282):1351-1362
pubmed: 33798499
N Engl J Med. 2022 Feb 10;386(6):531-543
pubmed: 34910859