An Indian vaccine targeting COVID-19 currently under development was helped along as its antigen was developed by the Texas Children’s Hospital Center for Vaccine Development at Baylor College of Medicine and subsequently in-licensed to the Indian company by BCM Ventures. That company, Biological E. Limited (BE), an Indian vaccine and pharmaceutical concern, recently announced the completion of their Phase 1/2 clinical trial of the COVID-19 subunit vaccine candidate and have now received greenlight for the pivotal Phase 3 trial from India’s Central Drugs Standard Control Organization (CDSCO).
A Dire Crisis
With India in the middle of a tragic pandemic surge, the hope is that this new vaccine can rapidly progress through this last phase and subsequently get released via emergency use authorization, reports Dr. Peter Hortez, professor and dean of the National School of Tropical Medicine at Baylor and co-director of the Texas Children’s Hospital Center for Vaccine Development.
Protein-based Vaccine Platform
While Dr. Maria Elena Bottazzi, associate dean of the National School of Tropical Medicine at Baylor and co-director of the Texas Children’s Hospital Center for Vaccine Development, shared recently, “Having our Texas Children’s and Baylor vaccine construct advance into phase III clinical studies in India and globally, highlights the importance of advancing traditional protein-based vaccine platforms, which now brings added hope for a people’s vaccine to be scaled and deployed in low- and middle-income settings.”
The vaccine also includes Dynavax Technologies Corporation’s advanced adjuvant CpG 1018TM. The Coalition for Epidemic Preparedness Innovations (CEPI) and the Biotechnology Industry Research Assistance Council (BIRAC) have provided support for the Phase I/II clinical trials and the upcoming Phase III trial.
The Phase 1/2 Study in India
BE’s Phase I/II clinical trial evaluated the safety and immunogenicity of the vaccine candidate. About 360 healthy subjects in the age range of 18 to 65 years took part. The vaccination schedule consisted of two doses for each study participant, administered via intramuscular injection 28 days apart. The vaccine was found to be safe, well-tolerated and immunogenic.
The Phase 3 Study
The Phase III clinical study will be conducted in 15 sites across India. It will evaluate the immunogenicity and safety of the vaccine for protection against COVID-19 disease in about 1268 healthy subjects in the age range of 18 to 80 years. It is intended to be part of a larger global Phase III study.
“We are delighted with the success of the Phase I/II clinical trials of our COVID-19 vaccine candidate. The results of these clinical trials are very positive and promising. We believe that our vaccine candidate will become another effective global COVID-19 vaccine as we move forward into Phase III clinical trials,” said Mahima Datla, managing director of Biological E. Limited.
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