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Serum Institute of India, the world’s largest vaccine manufacturer by volume and Nasdaq-listed biopharma company Dynavax Technologies Corporation stated they started dosing the initial participants as part of the Phase 1/2 clinical trial.
An adjuvant is used to boost the efficacy of this vaccine.
The Phase 1/2 clinical trial will assess the safety and immunogenicity of Serum Institute vaccine candidate composed of the SARS-COV-2 virus receptor binding domain (RBD) delivered as a virus-like particle (VPL), combined with Dynavax’s advanced adjuvant CpG 1018 and alum.
The Phase 1 portion of the clinical trial will enrol 39 healthy volunteers and post the conclusion of this study a decision will be taken regarding the dosing of up to 216 topics in Stage 2.
The vaccine has entered a Phase 1/2 trial in Australia.
“The collaboration with Dynavax is our effort in creating and investigating avenues to bolster our fight against the pandemic. We’re optimistic that providing the CpG 1018 adjuvant in the vaccine will boost the immune response of the candidate,” said Adar Poonawalla, Chief Executive Officer of Serum Institute.
“Through this we seek to provide our expertise and capacity to produce large amounts of affordable vaccine to supply global needs,” Poonawalla stated.
“We are pleased to be partnering with Serum Institute of India to advance their strategy to leverage a VLP utilizing the receptor binding domain of this SARS-COV-2 spike protein,” said Ryan Spencer, Chief Executive Officer, Dynavax.
“We believe continued development of multiple programs is critical to ensure the availability of safe and effective vaccines that may protect the global population from the devastating disease in the near term and for years to come,” Spencer said.
Serum Institute has been developing several vaccines for COVID-19 based on various platforms. The’Covishield’ in partnership with AstraZeneca-University of Oxford relies on non-replicating viral vector, Novavax – protein subunit and Codagenix – live-attenuated.
Each platform has its own advantages, for instance the VLP platform can be quickly ramped up in production.