Serum Institute of India (SII) and biopharmaceutical company Dynavax Technologies have dosed the first participants in the trial evaluating the former’s vaccine candidate adjuvanted with CpG 1018 for Covid-19.
This is the Phase I part of the Phase I/II clinical which will analyse the safety and immunogenicity of SII’s vaccine candidate in combination with Dynavax’s advanced adjuvant CpG 1018 plus alum.
The vaccine has SARS-COV-2 virus receptor binding domain (RBD) delivered as a virus-like particle (VPL).
CpG 1018 is the adjuvant used in an adult hepatitis B vaccine, Hepatitis B Vaccine (Recombinant), Adjuvanted (HEPLISAV-B), which is approved by the US Food and Drug Administration (FDA).
Dynavax developed CpG 1018, which can potentially provide an enhanced vaccine immune response.
SII partnered with Dynavax Technologies to develop the vaccine.
Serum Institute of India CEO Adar Poonawalla said: “We are hopeful that delivering the CpG 1018 adjuvant in the vaccine will enhance the immune response of the candidate.
“Through this we seek to provide our expertise and capability to produce large quantities of affordable vaccine to supply global needs.”
The Phase I segment of the trial will enrol 39 healthy participants and on completion of the study, a decision on the dosing of up to 216 subjects in the Phase II segment will be taken.
Dynavax CEO Ryan Spencer said: “We are pleased to be partnering with Serum Institute of India to advance their approach to leverage a VLP utilising the receptor binding domain of the SARS-COV-2 spike protein.
“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.”
In July, SII filed an application with the Drugs Controller General of India (DCGI) to study a Covid-19 vaccine candidate, being developed by the University of Oxford, in Phase II and III clinical trials.