Biological E. Limited (BE), a Hyderabad-based vaccines and pharmaceutical company, has initiated a Phase I/II clinical trial of its COVID-19 subunit vaccine candidate in India following approval from the Drugs Controller General of India (DGCI).
The announcement was made jointly by BE, Dynavax Technologies Corporation (Dynavax), a US-based vaccine focused biopharmaceutical company, and Baylor College of Medicine, a health sciences university in Houston.
“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 results of this clinical trial are expected to be available by February 2021, the release said.
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.
