Hyderabad-based pharmaceuticals & Biologics company Biological E. Limited (BE), has said it has initiated a Phase I/II clinical trial of its COVID-19 subunit vaccine candidate in India.
Along with Dynavax Technologies Corporation (Dynavax), a US-based vaccine focused biopharmaceutical company, and Baylor College of Medicine, a health sciences university in Houston, TX, BE has commenced the clinical trial.
DGCI approval
This move comes after receiving the formal 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.
According to BE, its Phase I/II clinical trial will evaluate the immunogenicity and safety 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.
Administered via intramuscular injection 28 days apart, the vaccination schedule consists of two doses for each study participant.
Dr. Maria Elena Bottazzi, associate dean of the National School of Tropical Medicine at Baylor College of Medicine and co-director of Texas Children’s Hospital Center for Vaccine Development, said, “The transition of our vaccine candidate into human trials is an important milestone, and exemplifies a successful transfer of technology with BE, that could lead to a safe, effective and affordable vaccine.”
Mahima Datla, Managing Director, Biological E. Limited, said, “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.”
The results of this clinical trial are expected to be available by February next year.
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(With inputs from The OnLook News Research Bureau)
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