CLOVER BIO-B(02197) initiates Phase I clinical trial of a respiratory syncytial virus (RSV) + human metapneumovirus (hMPV) parainfluenza virus type 3 (PIV3) respiratory combination vaccine candidate product.

Clover Biopharmaceuticals (02197) announced that the Phase I clinical trial evaluating the SCB-1022 (RSV + hMPV) and SCB-1033 (RSV + hMPV + PIV3) respiratory combination vaccine candidates has completed the enrollment of the first batch of subjects. The development of these vaccine candidates is based on the fusion-prefusion-stabilized F (PreF) trimer subunit vaccine antigens using Clover Biopharmaceuticals' protein trimerization vaccine technology platform. In October 2024, Clover Biopharmaceuticals released the Phase I clinical trial results of its adjuvant-free RSV PreF vaccine candidate (SCB-1019) conducted in 70 elderly subjects (60-85 years old). After a head-to-head comparison with GSK's RSV vaccine AREXVY using the AS01E adjuvant, the clinical results showed that SCB-1019 demonstrated potentially superior immunogenicity and tolerability characteristics. These clinical results support the further development and evaluation of the combination vaccine using SCB-1019 with hMPV and PIV3 fusion prefusion F-trimer antigens developed on the same protein trimerization platform. The ongoing Phase I clinical trial of the combination vaccine candidates by Clover Biopharmaceuticals will include up to 192 elderly subjects (60-85 years old), who will be randomly assigned to receive SCB-1022 (RSV + hMPV), SCB-1033 (RSV + hMPV + PIV3), or the control group SCB-1019 (RSV). This clinical study will evaluate safety, reactogenicity, and immunogenicity.