Bivalent RSV Vaccine Candidate Launches in China

Clover Biopharmaceuticals, Ltd. today announced that enrollment of the first participants has been completed in a Phase 1 first-in-human clinical study evaluating the company's RSV PreF-Trimer subunit vaccine candidate, SCB-1019. 

"We are pleased to be the first vaccine company based in China developing an RSV prefusion-stabilized F (PreF) vaccine to enter the clinical trial stage, establishing our leadership position in the space, which demonstrates the value of our validated Trimer-Tag platform and capabilities of our R&D team," said Joshua Liang, Chief Executive Officer and Board Director of Clover, in a press release on December 12, 2023.

"RSV vaccines remain a high unmet medical need, especially in China where no domestic RSV PreF vaccines have entered the clinical stage to date, but also globally where there is an opportunity for differentiation."

SCB-1019 is a bivalent RSV-A/RSV-B vaccine candidate based on the prefusion-stabilized F (PreF) protein leveraging the validated Trimer-Tag platform and proprietary stabilizing PreF mutations.

The new clinical trial is a randomized, placebo-controlled study to assess the safety, reactogenicity, and immunogenicity of SCB-1019 in young and older adults at multiple dose levels and in different formulations. Safety and immunogenicity results are expected by the second half of 2024.

As of December 13, 2023, there are approved RSV vaccines in various countries, and several vaccine candidates are conducting clinical trials.