Biological E. on Monday said the Phase I/II clinical trial of its COVID-19 subunit vaccine candidate has been initiated in the country.
The Hyderabad-based vaccines and pharmaceutical firm made this announcement with US-based biopharmaceutical firm Dynavax Technologies Corporation and Baylor College of Medicine, Houston. The launch of the trial follows approval from the Drugs Controller General of India (DGCI).
A release from Biological E. said the vaccine candidate includes an antigen in-licensed from BCM Ventures, Baylor College of Medicine’s integrated commercialisation team, along with Dynavax’s advanced adjuvant CpG 1018.
BE's Phase I/II clinical trial will evaluate the safety and immunogenicity of the vaccine candidate in about 360 healthy people in the 18 to 65 age group. The vaccination schedule consists of two doses for each participant, administered via intramuscular injection 28 days apart. The results of this clinical trial are expected to be available by February.
“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 of Biological E.
