Safety and Immunogenicity Evaluation of the Recombinant Flagellin Protein Adjuvant

NCT06768697 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: 2024-S084-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

adjuvant; novel adjuvant; flagellin; mucosal vaccine; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Safety Tolerance Evaluation Indicators

  Evaluate the adverse reactions of patients after vaccination according to the CTCAE standards, which include local reactions and systemic reactions, graded from level 1 to level 5.

  Screening period, Day1, Day2, Day22、Day23、Day43±2

Secondary Outcomes (4)

• IgA and IgG titers in saliva and nasal wash fluid

  saliva：Day1、Day22、Day43±2、Day112±5、Day202±5；nasal wash fluid：Day1、Day22、Day43±2、Day112±5、Day202±5

• plasma SARS-CoV-2 RBD-specific IgG and IgA titers

  Screening period, Day1、Day22、Day43±2、Day112±5、Day202±5

• plasma neutralizing antibody titers

  Day1、Day22、Day43±2、Day112±5、Day202±5

• Titers of flagellin-specific IgG and IgA in plasma

  Day1、Day22、Day43±2、Day112±5、Day202±5

Study Arms (4)

Group A

EXPERIMENTAL

A total of 15 participants were enrolled, with 12 receiving the KFD1+3R-NC (0µg + 80µg) nasal spray and 3 receiving the PBS nasal spray as a placebo control.

Biological: KFD1(0µg )

Group B

EXPERIMENTAL

A total of 15 participants were enrolled, with 12 receiving the KFD1+3R-NC (20µg + 80µg) nasal spray and 3 receiving the PBS nasal spray as a placebo control .

Biological: KFD1(20µg)

Group C

EXPERIMENTAL

A total of 15 participants were enrolled, with 12 receiving the KFD1+3R-NC (40µg + 80µg) nasal spray and 3 receiving the PBS nasal spray as a placebo control.

Biological: KFD1(40µg)

Group D

EXPERIMENTAL

A total of 15 participants were enrolled, with 12 receiving the KFD1+3R-NC (80µg + 80µg) nasal spray and 3 receiving the PBS nasal spray as a placebo control.

Biological: KFD1(80µg)

Interventions

KFD1(0µg ) BIOLOGICAL

SARS-CoV-2 subunit mucosal vaccine adjuvanted with flagellin protein(0µg + 80µg)

Group A

KFD1(20µg) BIOLOGICAL

SARS-CoV-2 subunit mucosal vaccine adjuvanted with flagellin protein(20µg + 80µg)

Group B

KFD1(40µg) BIOLOGICAL

SARS-CoV-2 subunit mucosal vaccine adjuvanted with flagellin protein(40µg + 80µg)

Group C

KFD1(80µg) BIOLOGICAL

SARS-CoV-2 subunit mucosal vaccine adjuvanted with flagellin protein(80µg + 80µg)

Group D

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects are healthy individuals aged between 18 and 65 years old (inclusive), with no gender preference, ensuring an appropriate gender ratio.
• Have received 2-3 doses of COVID-19 inactivated vaccine, and the last dose was administered more than 6 months ago.
• Have not been infected with COVID-19 within 3 months.
• Capable of being used in conjunction with nasal sprays, and also suitable for nasal irrigation, saliva collection, and blood collection.
• 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.
• 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.
• The subject is able to communicate effectively with the researcher and complete the study in accordance with the protocol.

You may not qualify if:

• Active or suspected viral, bacterial, fungal, or parasitic infections, including herpes, shingles, or cold sores, within 14 days prior to screening.
• History of recurrent infections of unknown causes; or use of systemic antibiotics within 90 days prior to drug administration.
• 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.
• Nasal malformation, trauma, or other reasons that make it impossible to use nasal sprays.
• 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.
• 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.
• Previous tests have found HIV-Ab positive, HCV positive, and anti-syphilis helical-specific antibody positive (please consult the subject).
• 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).
• Screen for the use of other medications, including prescription or non-prescription drugs, and herbal remedies, within the previous 4 weeks.
• Screen for individuals who have received vaccination within the previous 4 weeks or plan to receive vaccination during the study period.
• Individuals with a history of significant allergic reactions (anaphylaxis or angioedema) to any products (such as food and drugs), and known to be allergic to the test drug, its excipients, or similar drugs.
• Participate in any other drug clinical trials within 3 months before screening or within 5 half-lives of other clinical trial drugs (choose the longer time period).
• Exclude individuals who have donated plasma or whole blood exceeding 200 mL within the previous 3 months, except during menstruation.
• Individuals who abuse drugs or have used soft drugs (such as marijuana) within the past 3 months, or have consumed hard drugs (such as cocaine, phencyclidine, etc.) within the year prior to the trial; or individuals who test positive for drug abuse in urine screening (including methamphetamine, ketamine, MDMA, marijuana, morphine).
• Individuals who are alcoholics or have regularly consumed alcohol within the 6 months prior to the trial, with an average weekly alcohol intake exceeding 14 units (1 unit of alcohol is equivalent to approximately 360 mL of beer, 45 mL of spirits with a 40% alcohol content, or 150 mL of wine), or those who cannot abstain from alcohol during the trial period (interview).

Sponsors & Collaborators

• Shanghai Public Health Clinical Center: lead

Study Sites (1)

Shanghai Public Health Clinical Center,Fudan University

Shanghai, Jinshan District, 201508, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Doctor Wu

CONTACT

+8618918728223; wuqingguo@shphc.org.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 10, 2025
• Study Start: December 30, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From December 2025 to December 2026
• Access Criteria: Research information can be obtained after obtaining authorization from the researcher

Locations

CN (1)