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An Omicron-specific, self-amplifying mRNA booster vaccine for COVID-19: a phase 2/3 randomized trial

Medicine and Health

An Omicron-specific, self-amplifying mRNA booster vaccine for COVID-19: a phase 2/3 randomized trial

A. Saraf, R. Gurjar, et al.

This multicenter study explored the safety and effectiveness of the Omicron-specific GEMCOVAC-OM vaccine as a booster for adults previously vaccinated with BBV152 or ChAdOx1 nCoV-19. With promising results showing enhanced immunity against the B.1.1.529 variant, this research was conducted by a team of experts including Amit Saraf and Rohan Gurjar from Gennova Biopharmaceuticals Limited.

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Playback language: English
Abstract
This multicenter, open-label, randomized phase 2/3 study assessed the safety and immunogenicity of GEMCOVAC-OM, an Omicron-specific self-amplifying mRNA vaccine, as a booster in adults previously vaccinated with BBV152 or ChAdOx1 nCoV-19. GEMCOVAC-OM was well-tolerated. Phase 2 compared GEMCOVAC-OM to GEMCOVAC-19 (D614G variant-specific), showing higher IgG titers and seroconversion with GEMCOVAC-OM. Phase 3 compared GEMCOVAC-OM to ChAdOx1 nCoV-19, demonstrating GEMCOVAC-OM's superiority in neutralizing antibody titers and seroconversion rates. GEMCOVAC-OM proved safe and boosted immunity against the B.1.1.529 variant.
Publisher
Nature Medicine
Published On
May 01, 2024
Authors
Amit Saraf, Rohan Gurjar, Swarnendu Kaviraj, Aishwarya Kulkarni, Durgesh Kumar, Ruta Kulkarni, Rashmi Virkar, Jayashri Krishnan, Anjali Yadav, Ekta Baranwal, Ajay Singh, Arjun Raghuwanshi, Praveen Agarwal, Laxman Savergave, Sanjay Singh, Himanshu Pophale, Prakash Shende, Ravindra Baban Shinde, Vikram Vikhe, Abhishek Karmalkar, Bhaskar Deshmukh, Krishna Giri, Shrikant Deshpande, Ajay Bulle, Md. Sabah Siddiqui, Swapnav Borthakur, V. Reddy Tummuru, A. Venkateshwar Rao, Dhaiwat Shukla, Manish Kumar Jain, Pankaj Bhardwaj, Pravin Dinkar Supe, Manoja Kumar Das, Manoj Lahoti, Vijayakumar Barge
Tags
GEMCOVAC-OM
mRNA vaccine
Omicron variant
immunogenicity
safety
neutralizing antibodies
boosting immunity

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