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Safety and Immunogenicity Evaluation of the Recombinant Flagellin Protein Adjuvant

NCT06768697 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-01-10

No results posted yet for this study

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.

Conditions

  • COVID - 19

Interventions

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)

Sponsors & Collaborators

  • Shanghai Public Health Clinical Center

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-30
Primary Completion
2025-12-30
Completion
2025-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06768697 on ClinicalTrials.gov