Clover will begin phase 1 study of GSK’s Covid-19 S-Trimer vaccine (SCB-2019) in combination with GSKs pandemic adjuvant system
The research collaboration between healthcare company GSK and Clover Biopharmaceuticals, built on developing an adjuvanted Covid-19 vaccine, will begin human clinical trials.
Clover is a Chinese biotechnology company engaged in discovering, developing and commercialising biologic therapies for oncology and autoimmune diseases, in addition to viral vaccines.
Under the collaboration, Clover will initiate a Phase 1 clinical study evaluating the company’s Covid-19 S-Trimer vaccine (SCB-2019) in combination with GSKs pandemic adjuvant system.
The use of an adjuvant would play a key role in a pandemic situation, as it reduces the amount of protein required per dose, and allows the production of more vaccine doses to serve more people.
GSK Vaccines chief medical officer Thomas Breuer said: “Our deliberate approach is to combine our proven pandemic adjuvant technology with protein-based Covid-19 vaccine candidates from several collaborators. We believe this holds the promise to produce vaccines at scale, potentially benefiting billions of people.
“We are encouraged by the pre-clinical data of this adjuvanted Covid-19 vaccine candidate from Clover and look forward to reviewing the data from this first trial. If this trial is successful, we hope to be in a position to move into more advanced trials later in the year.”
The SCB-2019 vaccine candidate has demonstrated positive results from preclinical studies
The Phase 1 clinical trial will be a randomised, double-blind, placebo-controlled study to evaluate the safety, reactogenicity, and immunogenicity of SCB-2019 at multiple dose levels.
The study to be conducted at Linear Clinical Research in Perth, Australia will enrol around 90 healthy adult participants and 60 healthy elderly participants and is designed to evaluate each SCB-2019 dose level with and without adjuvant.
Coalition for Epidemic Preparedness Innovations (CEPI) is supporting the Phase 1 clinical trial, and Clover’s Covid-19 vaccine program by offering funding and collaboration.
The decision to initiate the clinical study is based on positive results from preclinical studies, which demonstrated the beneficial effect of GSKs pandemic adjuvant for the SCB-2019 vaccine candidate, with high neutralising antibody levels in multiple animal species, said the company.
The preliminary safety and immunogenicity results for the Phase 1 study are expected in August 2020, while the collaboration is planning for a Phase 2b/3 vaccine efficacy trial for later 2020.