Clover Biopharmaceuticals Launches U.S. Trial for RSV Booster Vaccine SCB-1019
By Thomas Yuan

CHENGDU — Clover Biopharmaceuticals has received investigational new drug (IND) approval from the U.S. Food and Drug Administration for its RSV vaccine candidate, SCB-1019, the company announced on March 24. The first batch of elderly participants has already been enrolled in a Phase I clinical trial to evaluate the safety and immunogenicity of SCB-1019 as a booster vaccine for respiratory syncytial virus.

The trial will recruit up to 160 subjects between the ages of 60 and 85, all of whom had previously received GSK’s AREXVY, the leading approved RSV vaccine, at least two seasons prior. Participants will be randomized to receive either a heterologous booster dose of SCB-1019, a homologous booster of AREXVY, or a placebo. The study aims to assess safety, reactogenicity, and immune response in the context of repeat vaccination.

The company’s approach leverages a trimeric PreF vaccine platform, which it has used in its COVID-19 program. Clover also announced plans to begin a combination respiratory vaccine trial in 2025, exploring a multivalent formulation of SCB-1019 with human metapneumovirus (hMPV) and potentially parainfluenza virus type 3 (PIV3).

The U.S. trial represents a strategic step forward for Clover as it expands its biopharmaceutical R&D footprint and pursues global development of next-generation respiratory vaccines. The RSV market, particularly for the elderly, remains a major area of unmet medical need, with increasing demand for high-quality health products that offer protection against multiple respiratory pathogens.

Clover’s push into the U.S. clinical landscape follows a broader trend of Chinese vaccine developers entering international regulatory pathways, underscoring China’s growing influence in the global medical technology and vaccine innovation sectors.

https://finance.eastmoney.com/a/202503243353780646.html