22 June 2020 | News
Global Phase 2b/3 vaccine efficacy study is in planning stage, targeting initiation by year-end 2020
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Clover Biopharmaceuticals, headquartered in China, has announced that the first participants have been dosed in the Phase 1 first-in-human study evaluating the company’s COVID-19 S-Trimer subunit vaccine candidate (SCB-2019), which is based on Clover’s proprietary Trimer-Tag© vaccine technology platform.
Preliminary safety and immunogenicity results for this Phase 1 study are expected in August 2020. In parallel, the planning for a global Phase 2b/3 vaccine efficacy trial has begun, with initiation targeted by year-end 2020.
The Phase I study will evaluate two adjuvant systems – GSK’s pandemic adjuvant system as well as Dynavax’s CpG 1018 adjuvant combined with alum. Clover has previously announced research collaborations with both GSK and Dynavax respectively.
The Phase I clinical trial is a randomized, double-blind, placebo-controlled study to assess the safety, reactogenicity, and immunogenicity of SCB-2019 at multiple dose levels. Each SCB-2019 dose level will be evaluated with and without adjuvant. The study is being conducted at Linear Clinical Research in Perth, Australia and will enroll approximately 90 healthy adult participants and 60 healthy elderly participants.
The trial and Clover’s COVID-19 vaccine program is being supported by the funding and collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI).