NCT06768697

Safety and Immunogenicity Evaluation of the Recombinant Flagellin Protein Adjuvant

Safety and Immunogenicity Evaluation of the Recombinant Flagellin Protein Adjuvant in the SARS-CoV-2 Subunit Mucosal Vaccine

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shanghai Public Health Clinical Center · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to learn if the SARS-CoV-2 subunit mucosal vaccine with the recombinant flagellin protein adjuvant works to Prevent COVID-19 infection. It will also learn about the Safety and immunogenicity of the vaccine.

Detailed description

This study explored the dosing of the 3R-NC containing BA.2.86 strain, EG.5 strain, and WIV 1 strain receptor binding domain（RBD） with the the recombinant flagellin protein adjuvant KFD1 （KFD1）in healthy subjects, further evaluating the safety, tolerability, and immunogenicity of the recombinant flagellin protein adjuvant KFD1 （KFD1） as a mucosal immune enhancer. KFD1 was divided into four dosage groups (0μg, 20μg, 40μg, 80μg), with each dosage group receiving two administrations. Safety assessments were conducted 7 days after each dosage group, and the next dosage group could only be administered after confirming safety. Samples including saliva, nasal wash, and blood were collected at different time points after the two vaccinations to evaluate safety and immunogenicity.

Conditions

• COVID - 19

Interventions

Type	Name	Description
BIOLOGICAL	KFD1(0µg )	SARS-CoV-2 subunit mucosal vaccine adjuvanted with flagellin protein(0µg + 80µg)
BIOLOGICAL	KFD1(20µg)	SARS-CoV-2 subunit mucosal vaccine adjuvanted with flagellin protein(20µg + 80µg)
BIOLOGICAL	KFD1(40µg)	SARS-CoV-2 subunit mucosal vaccine adjuvanted with flagellin protein(40µg + 80µg)
BIOLOGICAL	KFD1(80µg)	SARS-CoV-2 subunit mucosal vaccine adjuvanted with flagellin protein(80µg + 80µg)

Timeline

• Start date: 2024-12-30
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2025-01-10
• Last updated: 2025-01-10

Locations

1 site across 1 country: China