Phase II and III trial of mRNA Covid vaccine in city hospital

Nagpur: Meditrina Institute of Medical Sciences has once again been selected as a site to conduct clinical trials of another anti-covid vaccine.

After the successful completion of the Covaxin pediatric vaccine clinical trial, the institute is one of the sites in India for Phase-II and III clinical trials of the messenger RNA (mRNA) coronavirus vaccine.

Gennova Biopharmaceuticals Ltd., Pune has developed a brand new mRNA-based vaccine candidate – HGCO19 – and a Phase-III to DCGI 1 multicenter, active-controlled, randomized, observer-blind phase-II study After the study has been carried forward.

Also, the highest efficacy covid vaccines are messenger RNA vaccines manufactured by Pfizer/BioNTech and Moderna. The messenger RNA platform-based vaccines are also a promising alternative to conventional vaccine approaches because of their efficacy, high safety, and great ease of manufacture.

In the 2nd phase of the study itself, it will be done at about 10-15 sites. And the 3rd phase will be conducted at about 22-27 places. Dr. Ajay Bulle, Consultant Intensivist, is one of Meditrina’s principal investigators. He is greatly assisted by Dr. Tapan Bodele and the Institute’s Research, Nursing and Pharmacy staff under the guidance of its Director, Dr. Sameer Paltewar.

Total Seven Follow Up Visits

This study will be conducted in 2 parts. The Phase-2 part will be conducted in about 400 healthy subjects while the Phase-3 part of this study will also enroll about 4,000 healthy subjects. And with this, in the 2nd phase of this study, subjects will be enrolled in a 1:1 randomization scheme to receive either HGCO19 (10 µg) or the covid vaccine. Whereas in Phase-III, subjects will be enrolled in the ratio of 3:1 (HGCO19:Covidhidal).

A total of seven follow-up visits have also occurred in this study. Including this dose 1 on day 0 and covid dose 2 on day 29.

Its 2nd phase of enrollment and the follow-up visit on day 42 has just been completed. And with this, the institute has enrolled around 24 volunteers out of which about 23 are also in follow up action.

Its 3rd phase enrollment will start in the next 2-3 days only.

Dr. Sameer Paltewar has said that all citizens in the age group of 18 to 80 years who have not taken any vaccine at all while waiting for Modern/Pfizer Vaccine. All of them should come forward and become covid vaccine volunteers too.

The authorization will also be sought for emergency use of the covid vaccine after about 56 days without any untoward incident.

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