RTTNews | Mar 24, 2021 08:45AM EDT

08:45 Wednesday, March 24, 2021 (RTTNews.com) - Chinese biotechnology company Clover Biopharmaceuticals and US peer Dynavax Technologies Corp. (DVAX) announced Wednesday that the first participants have been dosed in Clover's SPECTRA trial.

It is a global Phase 2/3 clinical trial evaluating the protective-efficacy, safety and immunogenicity of Clover's trimeric recombinant protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax's CpG 1018 plus alum.

It is a double-blind, randomized, controlled study of the adjuvanted S-Trimer COVID-19 vaccine candidate in a two-dose regimen, given 21 days apart. The study is expected to enroll over 22,000 adult and elderly participants at multiple sites across Latin America, Asia, Europe and Africa.

An independent external Data Safety Monitoring Board (DSMB) will provide safety oversight throughout the program by regular review of available efficacy and safety data.

An interim analysis of the primary endpoint is expected in the middle of 2021, depending on trial enrollment and occurrence of COVID-19 cases in the study.

Utilizing Clover's proprietary Trimer-Tag technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. Trimer-Tag is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins.

The SPECTRA trial is fully funded by the Coalition for Epidemic Preparedness Innovations (CEPI). Through this collaboration, hundreds of millions of adjuvanted S-Trimer vaccine doses will potentially be made available for procurement and allocation through the COVAX Facility.

Read the original article on RTTNews ( https://www.rttnews.com/3179873/clover-dynavax-dose-first-patient-in-phase-2-3-trial-of-adjuvanted-covid-19-vaccine-candidate.aspx)

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