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COVID - 19Early Phase 1NCT06768697

Safety and Immunogenicity Evaluation of the Recombinant Flagellin Protein Adjuvant

A Early Phase 1 study testing KFD1(0µg ), KFD1(20µg) and KFD1(40µg) in people with COVID - 19, run by Shanghai Public Health Clinical Center at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
COVID - 19
What is being tested?
KFD1(0µg ), KFD1(20µg) and KFD1(40µg)
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
30 Dec 2024to 30 Dec 2025
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 23Show fewer
  • 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).
  • Subjects who have smoked an average of more than 5 cigarettes per day or used other nicotine-containing products (such as nicotine patches, nicotine gum, e-cigarettes, etc.) more than 5 times per day on average within the previous 3 months, or who cannot stop using any tobacco-related products during the trial period.
  • Those who have previously or currently suffered from any clinically severe diseases of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry, or metabolic abnormalities, or any other diseases that may interfere with the results of the trial.
  • Use other medications, including prescription or non-prescription drugs, and Chinese herbal medicine, from the screening date to D1.
  • Women who are pregnant, breastfeeding, or may become pregnant.
  • Clinical diagnosis of any autoimmune disease or rheumatic disease.
  • The patient's blood COVID-19 specific IgG antibody is greater than 1×10e4.
  • Any situation that other researchers consider unsuitable for participation in the study.
  • -

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Doctor Wu contact

+8618918728223

wuqingguo@shphc.org.cn

China1 site

  • Shanghai Public Health Clinical Center,Fudan University

    Shanghai, Jinshan District, 201508

    Wu Qingguo, +8618918728223, wuqingguo@shphc.org.cn

Other trials in China

About this study

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

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.

Read the 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
Being tested
KFD1(0µg ), KFD1(20µg), KFD1(40µg), KFD1(80µg)
Keywords
adjuvant, novel adjuvant, flagellin, mucosal vaccine, SARS-CoV-2
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KFD1(0µg )Biological

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

  • KFD1(20µg)Biological

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

  • KFD1(40µg)Biological

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

  • KFD1(80µg)Biological

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

Study groups in NCT06768697
Study groupRoleWhat they receive
Group AExperimentalA 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.
Receives: Biological: KFD1(0µg )
Group BExperimentalA 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 .
Receives: Biological: KFD1(20µg)
Group CExperimentalA 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.
Receives: Biological: KFD1(40µg)
Group DExperimentalA 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.
Receives: Biological: KFD1(80µg)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)

  1. IgA and IgG titers in saliva and nasal wash fluid

    Using the ELISA method, we detected RBD-specific IgA, IgG, as well as total IgA and IgG titers in saliva and nasal wash samples, and calculated the relative concentrations of RBD-specific IgA and IgG in total IgA and IgG.

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

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

    Determination of Plasma SARS-CoV-2 RBD-Specific IgG, IgA Titers

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

  3. plasma neutralizing antibody titers

    Using the ELISA method, we detected plasma neutralizing antibody titers

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

  4. Titers of flagellin-specific IgG and IgA in plasma

    Determination of flagellin-specific IgG and IgA in plasma

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2025
  2. Study start30 Dec 2024 (estimated)
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06768697
Sponsor's protocol ID
2024-S084-02
Status last verified
Jan 2025
First submitted
23 Dec 2024
Last updated
10 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: If you need to view it, you can apply to the applicant for access.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing KFD1(0µg ), KFD1(20µg) and KFD1(40µg) in people with COVID - 19, run by Shanghai Public Health Clinical Center at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Doctor Wu (+8618918728223, wuqingguo@shphc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Tolerance Evaluation Indicators (time frame: Screening period, Day1, Day2, Day22、Day23、Day43±2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06768697.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.

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