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Biological E starts human trials of COVID-19 vaccine candidate developed by US-based Baylor College

Biological E Ltd on Monday initiated the Phase I and II clinical trials of its COVID-19 subunit vaccine candidate, developed by US-based Baylor College of Medicine, in India following approval from the Drugs Controller General of India (DGCI). The vaccine candidate is fourth to start human trials in India.

India TV News Desk Edited by: India TV News Desk Hyderabad Published on: November 16, 2020 17:44 IST
Biological E starts human trials of COVID-19 vaccine candidate developed by US-based Baylor College
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Biological E starts human trials of COVID-19 vaccine candidate developed by US-based Baylor College

Biological E Ltd on Monday initiated the Phase I and II clinical trials of its COVID-19 subunit vaccine candidate, developed by US-based Baylor College of Medicine, in India following approval from the Drugs Controller General of India (DGCI). The vaccine candidate is fourth to start human trials in India.

The Hyderabad-based vaccine manufacturer has partnered with Baylor College and US-based Dynavax Technologies Corporation for development of the vaccine.

The company said it expects the results of the trial, which will evaluate the safety and immunogenicity of the vaccine candidate, to be available by February 2021.

"We are very happy indeed to transition our potential vaccine candidate to clinical trials and offer one more potential option for the prophylaxis of COVID-19," said Mahima Datla, Managing Director, Biological E. Limited. 

The vaccine candidate includes an antigen, in-licensed from BCM Ventures, Baylor College of Medicine's integrated commercialization team, along with Dynavax's advanced adjuvant CpG 1018, it said. Adjuvantis a pharmacological or immunological agent that improves the immune response of a vaccine.
 
BE's Phase I/II clinical trial will evaluate the safety and immunogenicity of the vaccine candidate at three dose levels adjuvanted with CpG 1018 plus alum, in about 360 healthy subjects in the age range of 18 to 65 years.
 
The vaccination schedule consists of two doses for each study participant, administered via intramuscular injection 28 days apart, the release said.

(With PTI inputs)

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