CureVac and GSK launch Phase 1 for Covid Booster

23.08.2022 - CureVac and GSK have announced they are launching a Phase 1 clinical trial with their modified mRNA-based Covid 19 vaccine CV051, which would be recommended as a booster to protect against the omicron variant.

The Tübingen, Germany-based biotech said the new shot is based on its “second-generation mRNA backbone” and demonstrates its continued execution on comprehensive clinical program of second-generation vaccine candidates for infectious diseases

At sites in the US, UK, Australia and the Philippines, CureVac plans to test CV0501 on 80 healthy previously vaccinated adults to evaluate the safety, reactogenicity and immunogenicity of a single booster in the dose range of 12 µg to 50 µg. 

Additional dose levels below 12 µg and above 50 µg may be evaluated if supported by safety and immunogenicity data at these dose levels, the company said.

In March, CureVac began Phase 1 trials with a second-generation Covid vaccine shot called CV2CoV that is aimed at the so-called wild type original coronavirus that kicked off the global pandemic in 2020. The company said the dual clinical approach will help determine the best candidate to advance into later-stage testing.

The two vaccines are part of GSK and CureVac’s larger infectious diseases collaboration, which features trials for the unmodified seasonal influenza candidate CVSQIV and the modified candidate FLU SV mRNA.

The companies originally began cooperating in July 2020, under a pact in which GSK paid more than €270 million upfront, including €150 million in equity, in exchange for five mRNA-based vaccine and monoclonal antibodies. The agreement was amended in February 2021 to include a Covid shot.

CureVac’s first mRNA-based vaccine, dubbed CVnCoV, disappointed in initial trials, and in October 2021 the company said it was withdrawing it from the ongoing approval process with the European Medicines Agency.

The German-British booster candidate is already behind Pfizer/BioNTech and Moderna, both of which have omicron-targeted shots on order worldwide. The US Food and Drug Administration and Health Canada are already running them through the emergency authorization process. The companies also have initiated the application process with the European Medicines Agency.

Author: Dede Williams, Freelance Journalist