Biological E begins phase I, II human trials of Covid vaccine
Hyderabad: Biological E. Limited, a Hyderabad-based vaccines and pharmaceutical company, Dynavax Technologies Corporation , a US-based vaccine focused biopharmaceutical company, and Baylor College of Medicine, a health sciences university in Houston, TX, have recently announced that BE 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 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.
BE's Phase I/II clinical trial will evaluate the safety and immunogenicity of the vaccine candidate consisting of the Receptor Binding Domain of the Spike Protein of SARS-CoV-2 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.
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