24 December 2020 | News
The Phase 1 portion of the clinical trial will enroll 39 healthy volunteers and post the completion of the study a decision will be taken regarding the dosing of up to 216 subjects in Phase 2.
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Serum Institute of India (SII) has partnered with Dynavax Technologies Corporation, a biopharmaceutical company focused on developing and commercialising novel vaccines, and jointly announced that the first participants have been dosed in the Phase 1 part of the Phase 1/2 clinical trial evaluating SIIPL's vaccine candidate adjuvanted with CpG 1018 to prevent COVID-19.
The Phase 1/2 clinical trial will evaluate the safety and immunogenicity of SIIPL's vaccine candidate consisting of the SARS-COV-2 virus receptor binding domain (RBD) delivered as a virus-like particle (VPL), along with Dynavax's advanced adjuvant CpG 1018 plus alum. The Phase 1 portion of the clinical trial will enrol 39 healthy volunteers and post the completion of the study a decision will be taken regarding the dosing of up to 216 subjects in Phase 2.
Sharing his thoughts, Adar Poonawalla, Chief Executive Officer, Serum Institute of India, said, "The collaboration with Dynavax is our effort in developing and exploring avenues to bolster our fight against the pandemic. We are hopeful that delivering the CpG 1018 adjuvant in the vaccine will enhance the immune response of the candidate.”
Ryan Spencer, Chief Executive Officer, Dynavax commented, "We believe continued development of multiple programmes is critical to ensure the availability of safe and effective vaccines that can protect the global population from this devastating disease in the near term and for years to come.”