TY - JOUR
T1 - Immune correlates analysis of a phase 3 trial of the AZD1222 (ChAdOx1 nCoV-19) vaccine
AU - on behalf of the AstraZeneca AZD1222 Clinical Study Group
AU - the Immune Assays Team
AU - the United States Government (USG)/CoVPN Biostatistics Team
AU - Benkeser, David
AU - Fong, Youyi
AU - Janes, Holly E.
AU - Kelly, Elizabeth J.
AU - Hirsch, Ian
AU - Sproule, Stephanie
AU - Stanley, Ann Marie
AU - Maaske, Jill
AU - Villafana, Tonya
AU - Houchens, Christopher R.
AU - Martins, Karen
AU - Jayashankar, Lakshmi
AU - Castellino, Flora
AU - Ayala, Victor
AU - Petropoulos, Christos J.
AU - Leith, Andrew
AU - Haugaard, Deanne
AU - Webb, Bill
AU - Lu, Yiwen
AU - Yu, Chenchen
AU - Borate, Bhavesh
AU - van der Laan, Lars W.P.
AU - Hejazi, Nima S.
AU - Carpp, Lindsay N.
AU - Randhawa, April K.
AU - Andrasik, Michele P.
AU - Kublin, James G.
AU - Isaacs, Margaret Brewinski
AU - Makhene, Mamodikoe
AU - Tong, Tina
AU - Robb, Merlin L.
AU - Corey, Lawrence
AU - Neuzil, Kathleen M.
AU - Follmann, Dean
AU - Hoffman, Corey
AU - Falsey, Ann R.
AU - Sobieszczyk, Magdalena
AU - Koup, Richard A.
AU - Donis, Ruben O.
AU - Gilbert, Peter B.
N1 - Publisher Copyright:
© 2023, The Author(s).
PY - 2023/12
Y1 - 2023/12
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85150233824&partnerID=8YFLogxK
U2 - 10.1038/s41541-023-00630-0
DO - 10.1038/s41541-023-00630-0
M3 - Article
AN - SCOPUS:85150233824
SN - 2059-0105
VL - 8
JO - npj Vaccines
JF - npj Vaccines
IS - 1
M1 - 36
ER -