Phase III Study to Test Safety and Immune Response of a New Recombinant Respiratory Syncytial Virus Vaccine CHO Cell With Adjuvant in Adults Aged 18 and Older

What this Trial Is About

Researchers are evaluating the safety, tolerability, and immune response of a recombinant respiratory syncytial virus RSV vaccine CHO cell with an adjuvant in adults aged 18 years and older. The study is conducted in two phases phase I focuses on safety and tolerability of different vaccine doses in adults 18 years and older, while phase II assesses immunogenicity and safety with varying adjuvant ratios in adults aged 60 years and older, including the persistence of immune responses. Participants receive a single intramuscular injection of the vaccine or placebo into the upper arm deltoid muscle on Day 0. Different groups receive varying doses and formulations of the vaccine, including adjuvanted and single or blank adjuvant versions, as well as a normal saline placebo. The trial is randomized, blinded, and controlled, comparing multiple investigational vaccine groups with placebo controls. During the study, participants undergo monitoring for adverse events, laboratory tests including blood biochemistry and coagulation, urinalysis, and electrocardiograms at specified days post-vaccination. Immune responses are measured by neutralizing antibody levels and specific IgG antibodies against RSV subtypes at multiple time points up to 24 months. Safety events, including serious adverse events, are tracked for 12 months post-vaccination. The total duration of follow-up and assessments extends up to two years.

Clinical Trial of Recombinant RSV Vaccine (CHO Cell) (Adjuvanted) in Chinese Population Aged 18 Years and Older.