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Safety and Immunogenicity Evaluation of the Recombinant Flagellin Protein Adjuvant | Clinical Trials | Clareo Health

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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

NCT06768697•Shanghai Public Health Clinical Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. The subjects are healthy individuals aged between 18 and 65 years old (inclusive), with no gender preference, ensuring an appropriate gender ratio.
•2. Have received 2-3 doses of COVID-19 inactivated vaccine, and the last dose was administered more than 6 months ago.
•3. Have not been infected with COVID-19 within 3 months.
•4. Capable of being used in conjunction with nasal sprays, and also suitable for nasal irrigation, saliva collection, and blood collection.
•5. Male subjects and their partners, or female subjects, must agree to adopt one or more non-drug contraceptive measures (such as complete abstinence, condoms, intrauterine devices, partner sterilization, etc.) during the trial period and for six months after the trial ends, and they must not have plans for sperm donation or egg donation.
•6. The subjects fully understand the purpose, nature, methods, and possible adverse reactions of the trial, voluntarily participate in the trial, and sign the informed consent form.
•7. The subject is able to communicate effectively with the researcher and complete the study in accordance with the protocol.

Exclusion Criteria

•1. Active or suspected viral, bacterial, fungal, or parasitic infections, including herpes, shingles, or cold sores, within 14 days prior to screening.
•2. History of recurrent infections of unknown causes; or use of systemic antibiotics within 90 days prior to drug administration.
•3. Individuals with malignant tumors or a history of malignant tumors, except for non-melanoma skin cancer that has been cured for more than 3 years.
•4. Nasal malformation, trauma, or other reasons that make it impossible to use nasal sprays.
•5. Individuals with a history of allergy to biological agents or any drug components; individuals with a history of allergies, such as asthma, aspergillus infection, allergic rhinitis, etc., who have been determined by researchers to be unsuitable for enrollment.
•6. Screen for outpatient or inpatient history of clinically significant chronic or acute disease symptoms within the previous 3 months, and ensure no surgical plans during the study period.
•7. Previous tests have found HIV-Ab positive, HCV positive, and anti-syphilis helical-specific antibody positive (please consult the subject).
•8. Individuals with abnormal vital signs (refer to normal range: systolic blood pressure 90\~139mmHg, diastolic blood pressure 60\~89mmHg, pulse rate 55-100 beats/min; body temperature (ear temperature) 35.4-37.7℃; respiratory rate 16-20 breaths/min) or abnormal electrocardiogram (QTcB≥450 ms, QTcB= QT/RR0.5) or clinically significant abnormalities in physical examination, laboratory tests (subject to the judgment of the clinical research doctor).
•9. Screen for the use of other medications, including prescription or non-prescription drugs, and herbal remedies, within the previous 4 weeks.
•10. Screen for individuals who have received vaccination within the previous 4 weeks or plan to receive vaccination during the study period.
+13 more criteria

Locations (1)

Shanghai Public Health Clinical Center,Fudan University

Shanghai, Jinshan District, China

Key Dates

Start Date

December 30, 2024

Primary Completion Date

December 30, 2025

Completion Date

December 30, 2025

Last Updated

January 10, 2025

Enrollment

ESTIMATED participants

Conditions

COVID - 19

Interventions

KFD1(0µg )

BIOLOGICAL

KFD1(20µg)

BIOLOGICAL

KFD1(40µg)

BIOLOGICAL

KFD1(80µg)

BIOLOGICAL

Contacts

Doctor Wu

CONTACT

+8618918728223 wuqingguo@shphc.org.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Immunogenicity Evaluation of the Recombinant Flagellin Protein Adjuvant

Inclusion Criteria

Exclusion Criteria

Immunogenicity of COVID-19 Vaccine Co-administration With Influenza Vaccine in Healthy Volunteers

Efficacy of Olfactive Training on Loss of Smell and Taste Caused by SARS CoV2 COVID-19 (Covid-Smell)

COVID-19 Infection and Thoracic Anesthesia?

Nasal Poly-ICLC (Hiltonol®) in Healthy COVID-19 Vaccinated Adults