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Clover Reports COVID-19 Vaccine Meets Endpoints in Global Phase II/III Trial

publication date: Sep 22, 2021
author/source: Richard Daverman, PhD

Clover, a Chengdu vaccine/biologic company, reported its adjuvanted protein-based COVID-19 vaccine candidate met its endpoints in a global, 30,000 person pivotal Phase II/II trial. SCB-2019 (CpG 1018/Alum) prevented 100% of severe COVID-19 vaccine and hospitalizations in all SARS-CoV-2 strains. Overall efficacy was 67% against COVID-19 of any severity caused by any strain. It posted 79% overall efficacy against COVID-19 of any severity in Delta subjects. Clover's trial was supported by CEPI, the Coalition for Epidemic Preparedness Innovations.

Efficacy was 92% against the Gamma variant and 59% against the Mu variant.  Collectively, the three strains (Delta, Gamma and Mu) comprised 73% of all strains identified in the study. Clover pointed out that its vaccine is one of the first to demonstrate significant efficacy against Delta in a double-blind, randomized clinical trial.

Clover expects SCB-2019 (CpG 1018/Alum) could be one of the first protein-based COVID-19 vaccines commercialized globally. The company used its Trimer-Tag™ technology platform to develop the SCB-2019 antigen, a stabilized trimeric form of the S-protein (referred to as S-Trimer™) based on the original strain of the SARS-CoV-2 virus. It added Dynavax's CpG 1018 advanced adjuvant and aluminum hydroxide (alum). to create the vaccine.

The SPECTRA clinical trial enrolled over 30,000 adult and elderly (≥18 years of age) participants at 31 sites in five countries (Philippines, Brazil, Colombia, South Africa, Belgium) across four continents, resulting in one of the most diverse COVID-19 vaccine clinical trials conducted to-date. SPECTRA was funded by CEPI as part of a up to $328 million investment to develop and enable equitable access to SCB-2019 (CpG 1018/Alum).

It is also the first COVID-19 vaccine candidate in the world to demonstrate in a randomized trial significantly reduced risk of COVID-19 disease in previously infected individuals. 49% of all SPECTRA participants were seropositive (evidence of prior SARS-CoV-2 infection) at baseline prior to enrollment. 41 cases of PCR-confirmed symptomatic COVID-19 reinfections were identified in this group, 17 of them caused by the Delta variant.

"SPECTRA enrolled participants during a time when the world encountered the rapid spread of increasingly transmissible SARS-CoV-2 variants and a takeover by Delta. Amidst this backdrop, we are pleased that SCB-2019 (CpG 1018/Alum) has successfully demonstrated efficacy against the globally dominant Delta strain and other concerning variants." said Joshua Liang, CEO of Clover Biopharma. "Based on our pioneering data, we believe that SCB-2019 (CpG 1018/Alum) could be utilized as an important tool to combat this pandemic, and we remain dedicated to expediting the availability and equitable access of our COVID-19 vaccine candidate for global distribution."

Dr. Ralf Clemens, Chairman of Clover's Scientific Advisory Board, said: "SCB-2019 (CpG 1018/Alum) successfully demonstrated significant vaccine efficacy against COVID-19 of any severity caused by Delta and other Variants of Concern and Interest. The safety profile of this adjuvanted protein-based vaccine candidate was favorable, with no significant differences in systemic adverse events or severe/serious adverse events compared to placebo."

Dr. Richard Hatchett, CEO of CEPI added, "This very encouraging data demonstrates the favorable safety profile of Clover's vaccine and its efficacy against multiple variants of SARS-CoV-2 – including the predominant Delta variant – so it will be a crucial addition to our weaponry in the fight against COVID-19."

Clover Biopharmaceuticals is a global clinical-stage biotechnology company committed to developing novel vaccines and biologic therapies using its Trimer-Tag™ technology.  

See our other articles on Clover.

Disclosure: none.




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