Vaccine Info

HGCO19 COVID-19 Vaccine

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Last reviewed
March 22, 2022

HGCO19 COVID-19 Vaccine Description for 2022

HGCO19 COVID-19 vaccine is India's first indigenous messenger RNA (mRNA) vaccine candidate.

mRNA vaccines carry the molecular instructions to make the protein in the body through a synthetic RNA of the targeted virus. The host body uses this to produce the viral protein that is recognized by the immune system, thereby making the body ready to fight against the disease.

The mRNA vaccine technology is synthetic in nature and is being used for the first time ever to combat any disease.

HGCO19 vaccine candidate contains a short, synthetic version encoding the spike protein (antigen) of the novel coronavirus, SARS-CoV-2, reported to interact with receptors on host cells.

When the vaccine is injected into the body the synthetic mRNA is taken to muscle cells where it instructs cells to make numerous copies of mRNA and copies of the antigen. 

HGCO19 COVID-19 Vaccine Indication

HGCO19 COVID-19 Vaccine is indicated to prevent COVID-19 disease, which is caused by the SARS-CoV-2 virus.

HGCO19 COVID-19 Vaccine News

April 12, 2021 - Gennova Biopharma is developing India's first indigenous mRNA COVID-19 vaccine and will receive government funding upon successful completion of its Phase 1 clinical trial.

HGCO19 COVID-19 Vaccine Clinical Trials

The Phase 1 clinical trial to assess the safety and immunogenicity of the vaccine candidate HGCO19 against COVID-19 in healthy adult participants. 

This Phase-1 study has enrolled 72 healthy participants in the age group of 18-70 years.  

This clinical trial will be studied at 4 different locations in India.

The Phase 2/3 study is A Prospective, Multicentre, Randomized, Active-controlled, Observer-blind, Phase II study seamlessly followed by a Phase III study to Evaluate the Safety, Tolerability, and Immunogenicity of the candidate HGCO19 (COVID-19 vaccine) in healthy subjects. 

This is a randomized, observer-blind, active-controlled, seamless, Phase II/III study. Phase II part will be conducted in 400 healthy subjects while Phase III part of the study will enroll 4000 healthy subjects between the ages of 18-80

Phase II of the study will enroll subjects in 1:1 randomization scheme to receive either HGCO19 (10 microgram) or COVISHIELD™ while Phase III will enroll subjects in ratio 3:1 (HGCO19: COVISHIELD™).

Thus, 4000 randomized subjects in Phase III study with 3000 randomized to HGCO19 arm and 1000 randomized to COVISHIELD™ arm will make ‘Safety Cohort’ of the study. A subset of these subjects will constitute the immunogenicity cohort. 

This study will be held at 36 sites in India.

Clinical Trials

No clinical trials found