Accès ouvert déclaré 2024 article

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

Prasad Suryakant Kulkarni, Chandrasekaran Padmapriyadarsini, Johan Vekemans, Ashish Bavdekar, Madhu Kumari Gupta, BS Garg, Nithya Gogtay, Muralidhar Tambe, Sanjay Kewalchand Lalwani, Kiranjit Singh, Renuka Munshi, Sushant Meshram, T. S. Selvavinayagam, Krishna Pandey, Devi Madhavi Bhimarasetty, Sivasubramanian Ramakrishnan, Chetanraj Bhamare, Abhijeet Dharmadhikari, Chandrashekhar Budhawant, Cyrille J. Bonhomme, Madhuri Rajeev Thakar, Swarali N. Kurle, Elizabeth J. Kelly, Manish Gautam, Nivedita Gupta, Samiran Panda, Balram Bhargava, Cyrus S. Poonawalla, Umesh S. Shaligram, Dhananjay Kapse, Bhagwat Gunale, Anand S. Kawade, Arunkumar Gondhali, Mini Pritam Singh, Ritin Mohindra, Pratibha Pereiera, M. R. Narayana Murthy, Abhishek V. Raut, Chetna H. Maliye, Ashwini Kalantri, Vijaya Laxman Chaudhari, Charuta J Godbole, Malangori A. Parande, Nandakumar Salunke, Sonali Hemant Palkar, Neeta Hanumante, Piyush R. Chaudhari, Shilpa P. Karande, Dipti A. Kumbhar, Shilpa Gupta, Sajal Mitra, Subramaniam Sudharshini, Venkatesan Prakash, Madhukar ., Abhik Sen, Sunita Sreegiri, Venkata Durga Prasad Vithanala, Tamilanbu Panneerselvam, Aiswarya M Nair, Atul Chaudhari, Silvester Patil

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Le résumé fourni par la source

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.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.

Le contrôle bibliographique ouvert

DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.

Titre Crossref: 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
Date Crossref: 21/03/2024
Éditeur: Informa UK Limited
Type: journal-article

Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.

Où se fait cette recherche

JSS Academy of Higher Education and Research pays non établi dans la notice
Université ou école supérieure
Serum Institute of India (India) pays non établi dans la notice
Entreprise
Indian Council of Medical Research pays non établi dans la notice
Organisme public
AstraZeneca (Sweden) pays non établi dans la notice
Entreprise
AstraZeneca (Brazil) pays non établi dans la notice
Entreprise
Post Graduate Institute of Medical Education and Research pays non établi dans la notice
Université ou école supérieure
Institute of Post Graduate Medical Education and Research pays non établi dans la notice
Université ou école supérieure
Mahatma Gandhi Institute of Medical Sciences pays non établi dans la notice
Établissement de santé
College of Medicine & JNM Hospital pays non établi dans la notice
Établissement de santé
B. J. Medical College & Sassoon Hospital pays non établi dans la notice
Université ou école supérieure
Bharati Vidyapeeth (Deemed to be University) pays non établi dans la notice
Université ou école supérieure
Jehangir Clinical development Centre pays non établi dans la notice
Structure de recherche

JSS Academy of Higher Education and Research, Serum Institute of India (India) et Indian Council of Medical Research, avec 9 autres affiliations.

Une affiliation ne permet pas de déduire la nationalité d’un auteur.

Les sujets associés

SARS-CoV-2 and COVID-19 ResearchCOVID-19 Clinical Research StudiesLong-Term Effects of COVID-19

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