Title: A phase 3, observer-blind, randomized, controlled study to determine the safety and immunogenicity of Covovax [sars-cov-2 recombinant spike protein nanoparticle vaccine (sars-cov-2 rs) with matrix-m1™ adjuvant] in Indian adults(Covovax study)

Sponsor: Serum Institute of India Private Limited (Siipl)

Co-Sponsor: Indian Council of Medical Research (ICMR)

Study Design: Observer -blind, Randomized, controlled, Multicentric Study

Intervention: COVOVAX OR Active controlled (Novavax- SARS-CoV-2 rS with MatrixM1™Adjuvant)

Condition: Prevention of COVID-19

Objectives: a. To assess the safety of COVOVAX in comparison with the Control vaccine (Novavax-SARS-CoV-2 rS with Matrix-M1™ Adjuvant)
b. To assess immunogenicity ofCOVOVAX in comparison with the Control vaccine by IgG ELISA assay

Study Initiation date: 24-Jun-2021  

Study population:1600 healthy individuals ≥ 18 years of age

Study duration: 9 months

Introduction and rational of the study: The COVID-19 epidemic has caused major disruption to healthcare systems with significant socioeconomic impacts. Containment measures have failed to stop the spread of virus, which has reached pandemic levels. There are currently no specific treatments available against COVID-19 and accelerated vaccine development is urgently needed. Novavax has developed SARS-CoV-2 rS Nanoparticle Vaccine with Matrix adjuvant. It has been already administered in approximately 100 healthy adults of 18 to 59 years in Phase 1/2 study in Australia without any serious safety concerns. Phase 2b and Phase 3 efficacy trials have been planned worldwide by Novavax. We will get efficacy data from a large number of subjects for this vaccine from various countries. Considering the large safety and efficacy data from these studies, we have planned this Phase 3 safety and immunogenicity study in Indian population for licensure in India.

Current status of the study: Ongoing