NCT06287450

A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine IN006 in Healthy Adults

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006) in Healthy Adult Participants

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Shenzhen Shenxin Biotechnology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

The study will evaluate the safety, tolerability, and immunogenicity of a single injection of up to 4 dose levels of IN006 in younger adults and 3 dose levels of IN006 in older adults; of a revaccination of IN006 given approximately 12 months after the initial vaccination in older adults.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
BIOLOGICAL	Bivalent RSV Vaccine (IN006)	Formulation for injection
BIOLOGICAL	Placebo	0.9% sodium chloride (normal saline) injection

Timeline

• Start date: 2026-12-01
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2024-03-01
• Last updated: 2026-04-13

Regulatory

• FDA-regulated drug study