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.

AZD1222 (ChAdOx1 nCoV-19) COVID-19 vaccine SARS-CoV-2 SII-ChAdOx1 nCoV-19 immunogenicity safety

Journal

Human vaccines & immunotherapeutics
ISSN: 2164-554X
Titre abrégé: Hum Vaccin Immunother
Pays: United States
ID NLM: 101572652

Informations de publication

Date de publication:
31 Dec 2024
Historique:
medline: 21 3 2024
pubmed: 21 3 2024
entrez: 21 3 2024
Statut: ppublish

Résumé

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

Identifiants

pubmed: 38512394
doi: 10.1080/21645515.2024.2304974
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

2304974

Auteurs

Prasad S Kulkarni (PS)

Serum Institute of India Pvt Ltd, Pune, India.

Chandrasekaran Padmapriyadarsini (C)

Indian Council of Medical Research, Delhi, India.

Johan Vekemans (J)

Formerly of: Clinical Development, Infection, Late-stage Development, Respiratory and Immunology (R&I), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.

Ashish Bavdekar (A)

KEM Hospital Research Centre, Pune, India.

Madhu Gupta (M)

Department of Community Medicine and School of Public Health, Post Graduate Institute of Medical Education & Research, Chandigarh, India.

Praveen Kulkarni (P)

Department of Community Medicine, JSS Academy of Higher Education and Research, Mysore, India.

B S Garg (BS)

Department of Community Medicine and Dr Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Wardha, India.

Nithya J Gogtay (NJ)

Department of Clinical Pharmacology, Seth G S Medical College & KEM Hospital, Mumbai, India.

Muralidhar Tambe (M)

Department of Community Medicine, B J Government Medical College and Sassoon General Hospitals, Pune, India.

Sanjay Lalwani (S)

Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Pune, India.

Kiranjit Singh (K)

Jehangir Clinical Development Centre Pvt Ltd, Pune, India.

Renuka Munshi (R)

Department of Clinical Pharmacology, TN Medical College & BYL Nair Hospital, Mumbai, India.

Sushant Meshram (S)

Department of Pulmonary Medicine, Government Medical College, Nagpur, India.

T S Selvavinayagam (TS)

Directorate of Public Health and Preventive Medicine, Chennai, India.

Krishna Pandey (K)

Rajendra Memorial Research Institute of Medical Sciences, Patna, India.

Devi Madhavi Bhimarasetty (DM)

Department of Community Medicine, Andhra Medical College, Visakhapatnam, India.

S R Ramakrishnan (SR)

Department of Clinical Research, Sri Ramchandra Institute of Higher Education and Research, Chennai, India.

Chetanraj Bhamare (C)

Serum Institute of India Pvt Ltd, Pune, India.

Abhijeet Dharmadhikari (A)

Serum Institute of India Pvt Ltd, Pune, India.

Chandrashekhar Budhawant (C)

Biostatistics, PPD India Pvt Ltd, Mumbai, India.

Cyrille J Bonhomme (CJ)

Laboratory Services, Vaccines Sciences Lab, Clinical Research, PPD, Part of Thermo Fisher Scientific, Richmond, VA, USA.

Madhuri Thakar (M)

Indian Council of Medical Research, Delhi, India.

Swarali N Kurle (SN)

Indian Council of Medical Research, Delhi, India.

Elizabeth J Kelly (EJ)

Formerly of: Translational Medicine, Vaccines and Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.

Manish Gautam (M)

Serum Institute of India Pvt Ltd, Pune, India.

Nivedita Gupta (N)

Indian Council of Medical Research, Delhi, India.

Samiran Panda (S)

Indian Council of Medical Research, Delhi, India.

Balram Bhargava (B)

Indian Council of Medical Research, Delhi, India.

Cyrus S Poonawalla (CS)

Serum Institute of India Pvt Ltd, Pune, India.

Umesh Shaligram (U)

Serum Institute of India Pvt Ltd, Pune, India.

Dhananjay Kapse (D)

Serum Institute of India Pvt Ltd, Pune, India.

Bhagwat Gunale (B)

Serum Institute of India Pvt Ltd, Pune, India.

Classifications MeSH