Study to check the safety and immune response of a COVID-19 vaccine in healthy Indian adults.

Conditions

None listed

Prasad S. Kulkarni, Chandrasekaran Padmapriyadarsini, Johan Vekemans, Ashish Bavdekar, Madhu Gupta et al. (65 authors)

Human Vaccines & Immunotherapeutics2024-03-212 citations

10.1080/21645515.2024.2304974

A Decision Support System to facilitate Vaccination for Covid-19 pandemic

A.K.N.S Madhurima Gayathri, Aishwarya. R. Pai, Joshua Samuel Raj. R

2022 International Conference on Computer Communication and Informatics (ICCCI)2022-01-253 citations

10.1109/iccci54379.2022.9740797

A phase 2/3, participant-blind, observer-blind, randomised, controlled study to assess the safety and immunogenicity of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine) in adults in India.

Kulkarni PS, Padmapriyadarsini C, Vekemans J, Bavdekar A, Gupta M, Kulkarni P, Garg BS, Gogtay NJ, Tambe M, Lalwani S, Singh K, Munshi R, Meshram S, Selvavinayagam TS, Pandey K, Bhimarasetty DM, Ramakrishnan SR, Bhamare C, Dharmadhikari A, Vadakkedath R, Bonhomme CJ, Thakar M, Kurle SN, Kelly EJ, Gautam M, Gupta N, Panda S, Bhargava B, Shaligram U, Kapse D, Gunale B, COVISHIELD Study Group.

2021-11-3031 citations

10.1016/j.eclinm.2021.101218

Interventions

Intervention1: Covishield (SII-ChAdOx1 nCoV-19): Covishield will be administered as 2 dose schedule on Days 1 and 29 as 0.5 ml dose intramuscularly. Control Intervention1: Oxford/AZ-ChAdOx1 nCoV-19 va

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy adults aged more than or equal to 18 years of either sex. 2. Written informed consent by participants. 3. The participant is resident of the study area and is willing to comply with study protocol requirements. 4. Healthy, as determined by medical history and physical examination. 5. Female participants of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccine administration.

Exclusion criteria

Exclusion criteria: 1. Acute illness with or without fever at the time of study vaccine administration 2. History of laboratory confirmed COVID-19 disease in household contact or close workplace contact 3. IgG seropositivity to SARS-CoV-2 4. History or currently positive for SARS-CoV-2 by RT-PCR 5. History of severe allergic reactions after previous vaccinations or hypersensitivity to any component of study vaccines 6. Any confirmed or suspected condition with impaired/altered function of immune system

Design outcomes

Primary

Measure	Time frame
1. Occurrence of causally related SAEs throughout the study duration following vaccination 2. Ratio of GMTs of anti-S IgG antibodiesTimepoint: 1. Throughout the study duration following vaccination 2. 28 days after the second vaccination	—

Secondary

Measure	Time frame
Occurrence of serious adverse events (SAEs)Timepoint: Throughout the study duration following vaccination;Occurrence of solicited local and/or systemic adverse events (AEs)Timepoint: 7 days following each vaccination;Occurrence of unsolicited adverse eventsTimepoint: 28 days following each vaccination	—

Countries

India

Contacts

Public ContactDr Prasad Kulkarni

Serum Institute of India Private Limited

drpsk@seruminstitute.com00912026602949

Outcome results