A phase 1 study evaluating the safety, reactogenicity and immunogenicity of SCB-2019, a vaccine candidate for coronavirus disease 2019 (COVID-19), has been initiated by Clover Biopharmaceuticals.
SCB-2019 is an investigational protein-based COVID-19 S-Trimer vaccine that utilizes Clover’s proprietary technology (Timer-Tag©) in combination with GlaxoSmithKline’s pandemic adjuvant. According to preclinical data, the addition of the adjuvant to SCB-2019 has resulted in high neutralizing antibody levels in multiple animal species.
The randomized, double-blind, placebo-controlled phase 1 study will assess SCB-2019 at multiple dose levels with and without adjuvant in approximately 90 healthy adult patients and 60 healthy elderly patients at the Linear Clinical Research in Perth, Australia. The Company expects preliminary safety and immunogenicity results for the phase 1 study in August 2020. Additionally, a global phase 2b/3 vaccine efficacy trial is anticipated to begin later in 2020.
The incorporation of an adjuvant may allow for greater production of vaccine doses, as the amount of protein required per dose would be reduced. Vaccine adjuvants are also used to enhance and prolong immune responses.
“Our deliberate approach is to combine our proven pandemic adjuvant technology with protein-based COVID-19 vaccine candidates from several collaborators,” said Thomas Breuer, Chief Medical Officer, GSK Vaccines. “We believe this holds the promise to produce vaccines at scale, potentially benefiting billions of people.” The Company is collaborating with several partners in North America, Europe and China to develop vaccines for COVID-19.