Seropersistence of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine): 6-month follow-up of a randomized,controlled, observer-blind, phase 2/3 immuno-bridging study in Indian adults

Kulkarni, P S and Chandrasekaran, Padmapriyadarsini and Vekemans, J and Bavdekar, A and Gupta, M and Kulkarni, P and Garg, B S and Nithya, J and Gogtay, Gogtay and Tambe, M and Lalwani, S and Singh, Kiranjit and Munshi, R and Meshram, S and Selvavinayagam, T S and Pandey, Krishna and Bhimarasetty, D M and Ramakrishnan, S R and Bhamare, C and Dharmadhikari, A and Budhawant, C and Bonhomme, Cyrille J and Thakar, M and Kurle, S N and Gautam, M and Gupta, Nivedita and Panda, Samiran and Bhargava, Balram and Poonawalla, Cyrus S and Shaligram, U and Kapse, D and Gunale, B (2024) Seropersistence of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine): 6-month follow-up of a randomized,controlled, observer-blind, phase 2/3 immuno-bridging study in Indian adults. Seropersistence of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine): 6-month follow-up of a randomized,controlled, observer-blind, phase 2/3 immuno-bridging study in Indian adults, 20 (1).

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Abstract

AZD1222 (ChAdOx1 nCoV-19) is a replication-deficient adenoviral vectored coronavirus disease-19 (COVID-19) vaccine that is manufactured as SII-ChAdOx1 nCoV-19 by the Serum Institute of India Pvt Ltd following technology transfer from Oxford University/AstraZeneca. The non-inferiority of SII-ChAdOx1 nCoV-19 with AZD1222 was previously demonstrated in an observer-blind, phase 2/3 immuno-bridging study (trial registration: CTRI/2020/08/027170). In this analysis of immunogenicity and safety data 6 months post first vaccination (Day 180), 1,601 participants were randomized 3:1 to SII-ChAdOx1 nCoV-19 or AZD1222 (immunogenicity/reactogenicity cohort n = 401) and 3:1 to SII-ChAdOx1 nCoV-19 or placebo (safety cohort n = 1,200). Immunogenicity was measured by anti-severe acute respiratory syndrome coronavirus 2 spike (anti-S) binding immunoglobulin G and neutralizing antibody (nAb) titers. A decline in anti-S titers was observed in both vaccine groups, albeit with a greater decline in SII-ChAdOx1 nCoV-19 vaccinees (geometric mean titer [GMT] ratio [95% confidence interval (CI) of SII-ChAdOx1 nCoV-19 to AZD1222]: 0.60 [0.41-0.87]). Consistent similar decreases in nAb titers were observed between vaccine groups (GMT ratio [95% CI]: 0.88 [0.44-1.73]). No cases of severe COVID-19 were reported following vaccination, while one case was observed in the placebo group. No causally related serious adverse events were reported through 180 days. No thromboembolic or autoimmune adverse events of special interest were reported. Collectively, these data illustrate that SII-ChAdOx1 nCoV-19 maintained a high level of immunogenicity 6 months post-vaccination. SII-ChAdOx1 nCoV-19 was safe and well tolerated.

Affiliation:	ICMR-National Institute for Research in Tuberculosis
Item Type:	Article
Uncontrolled Keywords:	AZD1222 (ChAdOx1 nCoV-19); COVID-19 vaccine; SARS-CoV-2; SII-ChAdOx1 nCoV-19; immunogenicity; safety.
Subjects:	Tuberculosis > Clinical Research
Divisions:	Clinical Research
Depositing User:	Mrs. N Lakshmi
Date Deposited:	02 Apr 2024 05:53
Last Modified:	02 Apr 2024 05:53
URI:	http://eprints.nirt.res.in/id/eprint/1999

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