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To manage patients
infected with COVID-19, a phase I clinical trial to determine safety,
immunogenicity, and reactogenicity of vaccine SCB-2019 has started.
China-based Clover Biopharmaceuticals has initiated a phase 1 study to explore the safety, reactogenicity, and immunogenicity of SCB-2019, (a vaccine candidate for COVID-19) at multiple dose levels. Each dose level of the investigational COVID-19 vaccine will be determined with and without adjuvant.
At Linear Clinical Research in Perth, Australia, this phase I, randomized, placebo-controlled, double-blind clinical trial is being carried out. The study will recruit approximately and 60 healthy elderly subjects and 90 healthy adult subjects.
SCB-2019 is a recombinant protein-based COVID-19 S-Trimer subunit vaccine. It is based on Clover’s proprietary technology Timer-Tag vaccine technology platform in combination with Glaxo Smith Kline’s pandemic adjuvant. The data from preclinical studies illustrated that the incorporation of the adjuvant to SCB-2019 has elicited the levels of neutralizing antibodies in diverse animal species.
In August 2020, the preliminary immunogenicity and safety results for the phase 1 study are anticipated. Moreover, a global phase 2b/3 vaccine efficacy study is anticipated to begin later in 2020. In such a pandemic scenario, the addition of an adjuvant is pivotal since it can diminish the amount of protein required per dose.
This will enable higher production of vaccine doses to make it available for more patients. Adjuvants added to vaccines may also improve the immune responses, thereby creating a stronger and longer-lasting immunity against infections when compared to the vaccine alone.
The company is aiming to collaborate the validated pandemic adjuvant technology with protein-based COVID-19 vaccine candidates from numerous collaborators. This will aid the production of vaccines at scale, potentially benefiting billions of patients infected with SARS-CoV-2. The Company is working together with various partners in China, North America, and Europe to produce vaccines for managing COVID-19 patients.
MPR
Phase 1 Study of Adjuvanted COVID-19 Vaccine Candidate Begins
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