Health TrialsbyHealthPanel

Safety and Immunogenicity Evaluation of the Recombinant Flagellin Protein Adjuvant

ConditionCOVID - 19
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShanghai Public Health Clinical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • KFD1(0µg )

    Biological/Vaccine

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

  • KFD1(20µg)

    Biological/Vaccine

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

  • KFD1(40µg)

    Biological/Vaccine

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

  • KFD1(80µg)

    Biological/Vaccine

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

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BExperimental treatment 1 intervention
Group C: Group CExperimental treatment 1 intervention
Group D: Group DExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

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.

Time frame
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

Time frame
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

Time frame
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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Public Health Clinical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: