NCT06754605

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Recombinant Respiratory Syncytial Virus Vaccine

A Randomized, Double-blind, Placebo-controlled Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Recombinant Respiratory Syncytial Virus Vaccine (SCTV02) in Healthy Adults ≥18 Years of Age

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Sinocelltech Ltd. · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Accepted

Summary

This is a randomised, double-blind, placebo-controlled Phase 1/2 clinical trial to evaluate the safety, tolerability and immunogenicity of recombinant respiratory syncytial virus in participants aged 18 years and older.

Detailed description

Three dose-levels of SCTV02 will be evaluated in participants aged 18 years and older. Solicited adverse events within 7 days post study vaccination and unsolicited adverse events within 30 days post study vaccination will be collected. Immunogenicity including Neutralizing antibody against RSV-A and RSV-B will be tested 14, 30, 90, 180 and 365 days post study vaccination will be assessed. T cell response will be tested 30 days post study vaccination.

Conditions

• Respiratory Syncytial Virus

Interventions

Type	Name	Description
BIOLOGICAL	SCTV02	Participants will receive a singe dose of SCTV02 on Day 0.
BIOLOGICAL	Placebo	Participants will receive a singe dose of Placebo on Day 0.

Timeline

• Start date: 2025-02-06
• Primary completion: 2027-07-30
• Completion: 2027-07-30
• First posted: 2025-01-01
• Last updated: 2025-02-13

Locations

2 sites across 1 country: China