NCT06642558

Safety and Immunogenicity of Recombinant RSV Vaccine (CHO Cell) in Healthy Subjects Aged 18 Years and Above

A Phase I/II, Single Center, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) in Healthy Subjects Aged 18 Years and Above

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 522 (estimated)
• Sponsor: MAXVAX Biotechnology Limited Liability Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety and immunogenicity of two dose levels of the single dose Recombinant RSV vaccine(CHO cells), when administered intramuscularly (IM) in healthy adults aged 18 years and older.

Detailed description

A total of 522 subjects in the phase 1/2 study will be enrolled. The study will be conducted in 2 parts (phase 1 for dose escalation and phase 2 for expansion), with first evaluation of safety of 2 two dose levels of Recombinant RSV vaccine(CHO cells) in healthy participants aged 18-59 and ≥60 in phase 1 before preceding with vaccination of the participants aged 50-59 and ≥60 in phase 2. To ensure the safety of the study participants, phase 1 will follow a staggered enrolment with 3 steps. All subjects in each age group in phase 1 will be randomly receive the investigational vaccine(half or full dose) and the placebo in a 2:1 ratio, while all subjects in each age group in phase 2 will be randomly receive the half dose vaccine, the full dose vaccine and the placebo in a 1:1:1 ratio.

Conditions

• Respiratory Syncytial Virus (RSV)

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(low dose)	0.25 mL per dose.
BIOLOGICAL	Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose)	0.5 mL per dose
BIOLOGICAL	Placebo (Saline solution)	0.5 mL per dose

Timeline

• Start date: 2024-11-13
• Primary completion: 2025-06-30
• Completion: 2027-02-28
• First posted: 2024-10-15
• Last updated: 2025-06-06

Locations

1 site across 1 country: China