GSK COVID-19 vaccine development collaboration with Clover Biopharmaceuticals begins clinical trials

GlaxoSmithKlineGSK's scientific collaboration with Clover Pharmaceuticals to develop an adjuvanted COVID-19 vaccine has entered into human clinical trials. Clover announced the initiation of a Phase 1 clinical study evaluating the company’s COVID-19 S-Trimer vaccine (SCB-2019) in combination with GSKs pandemic adjuvant system.

The study initiation follows promising preclinical results which demonstrated the beneficial effect of GSKs pandemic adjuvant for the SCB-2019 vaccine candidate, with high neutralizing antibody levels elicited in multiple animal species.

Preliminary safety and immunogenicity results for the 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 later in 2020.

The use of an adjuvant is of particular importance in a pandemic situation since it can reduce the amount of protein required per dose, allowing more vaccine doses to be produced and made available to more people.

GSK has announced several scientific collaborations globally to develop adjuvanted COVID-19 vaccines. GSK expects further studies to begin across the range of its collaborations, including with Sanofi, later this year.

Thomas Breuer, Chief Medical Officer, GSK Vaccines, 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."

Clover Biopharmaceuticals is a China-based, global, clinical-stage, research-based biotechnology company focused on discovering, developing and commercializing transformative biologic therapies, with a focus on oncology and autoimmune diseases, as well as viral vaccines. The research collaboration between GSK and Clover to develop a COVID-19 vaccine candidate was announced on 24th February 2020.

About the study

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 enrol 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).

About GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.

Most Popular Now

Johnson & Johnson announces European Commissio…

Johnson & Johnson (NYSE: JNJ) (the Company) announced the European Commission (EC), acting on behalf of the European Union (EU) Member States, has approved an Advance Pur...

COVID-19 Long-Acting AntiBody (LAAB) combination A…

AstraZeneca's long-acting antibody (LAAB) combination, AZD7442, will advance into two Phase III clinical trials in more than 6,000 participants at sites in and outside th...

BioNTech and Pfizer initiate rolling submission to…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a rolling submission to the European Medicines Agency (EMA) for BNT162b2, the lea...

Vir Biotechnology and GSK announce global expansio…

Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) announced the global expansion to Phase 3 of the COMET-ICE (COVID-19 Monoclonal antibody Eff...

Johnson & Johnson initiates pivotal global Pha…

Johnson & Johnson (NYSE: JNJ) (the Company) announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, J...

Gilead Sciences signs joint procurement agreement …

Gilead Sciences (Nasdaq: GILD) and the European Commission signed a joint procurement agreement (JPA) that will enable rapid and equitable access to Veklury® (remdesivir)...

COVID-19 vaccine AZD1222 clinical trial resumed in…

The Phase I/II clinical trial for the COVID-19 vaccine AZD1222 has resumed in Japan after discussion with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). ...

Regeneron's REGN-COV2 antibody cocktail reduced vi…

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the first data from a descriptive analysis of a seamless Phase 1/2/3 trial of its investigational antibody cockta...

Potential COVID-19 vaccines not affected by domina…

Vaccines currently being developed for COVID-19 should not be affected by recent mutations in the virus, according to a new study involving a University of York virologis...

Protective antibodies persist for months in surviv…

People who survive serious COVID-19 infections have long-lasting immune responses against the virus, according to a new study led by researchers at Massachusetts General ...

Popular COVID-19 conspiracies linked to vaccine 'h…

A new study of beliefs and attitudes toward COVID-19 in five different countries - UK, US, Ireland, Mexico and Spain - has identified how much traction some prominent con...

Sanofi and Translate Bio mRNA COVID-19 vaccine can…

Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, today announced...