Evaluation of Corfluvec Vaccine for the Prevention of COVID-19 in Healthy Volunteers

NCT05696067 | Completed Phase 1 DMC

• 1 other identifier: KFV-I/II-01/2022
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the study is to investigate the safety and immunogenicity of a two-component intranasal vaccine for the prevention of COVID-19 in healthy volunteers 18-60 years old

Conditions

COVID-19

Keywords

COVID-19; vaccine; influenza vector

Outcome Measures

Primary Outcomes (4)

• Number of participants with local and systemic adverse events (AEs) and serious adverse events (SAEs)

  Number of participants with AEs and SAEs including those of particular interest: * immediate AEs (allergic reactions) occurring within 2 h after vaccination; * post-vaccination reactions between 2 h and a subsequent 7 days; * other AEs including unexpected clinical manifestations of a local and systemic nature occurring on the day of vaccination and the following 7 days; * deviations of laboratory parameters of analyzes of blood and urine samples and data from instrumental studies (ECG) obtained on Days 3, 7, 23 and 27; * all SAEs occurring up to 3 weeks after each vaccination; late AEs occurring after study Day 42 through Day 180±5; * influenza A virus shedding detected by rapid test in nasal swab samples

  Throughout the study, average of 6.5 months

• Level of SARS-CoV-2 antigen specific cytokine producing T-cells

  Change from baseline in the level of cytokine producing T-cells upon in vitro stimulation of PBMC with SARS-CoV-2 N protein peptide epitopes measured by ICS/ELISPOT

  Throughout the 42±2 study days

• Level of SARS-CoV-2 antigen specific cytokine release in whole blood assay

  Change from baseline in the cytokine concentration in whole-blood cytokine release assay upon in vitro stimulation with SARS-CoV-2 N protein peptide epitopes

  Throughout the 42±2 study days

• Level of SARS-CoV-2 antigen specific mucosal and systemic IgA and IgG antibody

  Change from baseline in the levels of IgA and IgG antibody to SARS-CoV-2 N protein measured in ELISA in saliva/nasal secret and serum

  Throughout the 42±2 study days

Secondary Outcomes (2)

• Number of responders to vaccination according to the fold increase in the level of specific T-cell response

  Days 7, 21, 27, 42±2

• Seroconversion rate of SARS-CoV-2 antigen specific antibody

  Days 21, 42±2

Other Outcomes (4)

• Concentration of cytokines in nasal secrets after vaccination

  Throughout the first 48h of the study

• Influenza specific local and systemic antibody immune response

  Throughout the 42±2 study days

• SARS-CoV-2 and influenza specific antibody and T-cell immune response (follow-up)

  Days 90±3, 180±5

Study Arms (9)

Group 0a

EXPERIMENTAL

Single dose of 7.2 lg EID50 of H3N2 vaccine component

Biological: Corfluvec component 1 low dose

Group 0b

EXPERIMENTAL

Single dose of 7.5 lg EID50 of H1N1pdm09 vaccine component

Biological: Corfluvec component 2 low dose

Group 0c

EXPERIMENTAL

Single dose of 8.0 lg EID50 of H3N2 vaccine component

Biological: Corfluvec component 1 high dose

Group 0d

EXPERIMENTAL

Single dose of 8.3 lg EID50 of H1N1pdm09 vaccine component

Biological: Corfluvec component 2 high dose

Group 1a

EXPERIMENTAL

Low dose vaccine, two components received three weeks apart

Biological: Corfluvec low dose

Group 1b

EXPERIMENTAL

High dose vaccine, two components received three weeks apart

Biological: Corfluvec high dose

Group 1c

PLACEBO COMPARATOR

Placebo, two doses received three weeks apart

Biological: Placebo

Group 2a

EXPERIMENTAL

High dose vaccine, two components received three weeks apart

Biological: Corfluvec high dose

Group 2b

PLACEBO COMPARATOR

Placebo, two doses received three weeks apart

Biological: Placebo

Interventions

Corfluvec component 1 low dose BIOLOGICAL

Participants will receive single intranasal injection of H3N2 recombinant attenuated influenza vector with modified NS gene coding for the N protein fragment of SARS-CoV-2

Group 0a

Corfluvec component 2 low dose BIOLOGICAL

Participants will receive single intranasal injection of H1N1pdm09 recombinant attenuated influenza vector with modified NS gene coding for the N protein fragment of SARS-CoV-2

Group 0b

Corfluvec component 1 high dose BIOLOGICAL

Participants will receive single intranasal injection of H3N2 recombinant attenuated influenza vector with modified NS gene coding for the N protein fragment of SARS-CoV-2

Group 0c

Corfluvec component 2 high dose BIOLOGICAL

Participants will receive single intranasal injection of H1N1pdm09 recombinant attenuated influenza vector with modified NS gene coding for the N protein fragment of SARS-CoV-2

Group 0d

Corfluvec low dose BIOLOGICAL

Participants will receive two intranasal injections of recombinant attenuated influenza vector with modified NS gene coding for the N protein fragment of SARS-CoV-2 tree weeks apart (H3N2 →H1N1pdm09)

Group 1a

Corfluvec high dose BIOLOGICAL

Participants will receive two intranasal injections of recombinant attenuated influenza vector with modified NS gene coding for the N protein fragment of SARS-CoV-2 tree weeks apart (H3N2 →H1N1pdm09)

Group 1b; Group 2a

Placebo BIOLOGICAL

Participants will receive two intranasal injections of placebo three weeks apart

Group 1c; Group 2b

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Availability of signed informed consent
• Adult men and women aged 18-60
• Diagnosed "healthy" according to the data of standard clinical, laboratory and instrumental examination methods, with the absence of clinically significant changes
• Body Mass Index (BMI): 18.5≤ BMI ≤30 kg/m2
• HI antibody titers ≤1:20 to influenza A/H1N1pdm09 and A/H3N2 (only for phase 1)
• Serum antibodies to the SARS-CoV-2 N-protein not higher than 100 BAU/ml
• The ability and willingness to make entries in the diary of self-observation, as well as to carry out all the visits foreseen in the study for control medical observation
• Negative test for alcohol in exhaled air
• Consent to use effective contraceptive methods throughout their participation in the study
• Values of the complete blood count and biochemical blood analysis (during the screening) within 0.9\*reference range lower limit and 1,1 \* reference range upper limit
• Negative tests for HIV, hepatitis B, hepatitis C, and syphilis

You may not qualify if:

• Contact with COVID-19 patients within 14 days prior to the start of the clinical study
• Positive rapid test result for SARS-CoV-2 antigen
• Participation in another clinical study within three months prior to the start of the current study; planning to participate in another study during the current study period.
• Immunization with any other non-study vaccine product, including COVID-19 vaccination within four weeks prior to enrollment in the current study, or refusal to postpone such until the end of the four-week period after completion of the current study
• Regular use of nasal irrigation therapy during the last six months prior to enrollment in the current study or episodic use of the above method of treatment in the two weeks prior to the screening
• History of frequent nosebleeds (\>5) during the year prior to the current study
• Clinically significant anatomic pathology or the presence of surgical intervention in the sinus area, paranasal sinuses, or traumatic injuries of the nose within a month before screening
• Symptoms of acute respiratory disease, including fever, or other acute illness at the time of screening or within two weeks prior to screening
• Treatment with immunoglobulins or other blood derived medications in the three months prior to screening or planning such treatment during the period of participation in the current study; donation of blood/plasma (450 ml or more) less than 2 months prior to screening
• The presence or suspicion of the presence of various immunosuppressive or immunodeficiency conditions or continuous use (the drug was prescribed for more than 14 days without a break) of immunosuppressive drugs, immunomodulators for 6 months before the screening
• History of bronchial asthma
• Hypersensitivity and the presence of severe allergic reactions, including Quincke's edema, anaphylactic shock after the previous administration of any vaccine
• History of wheezing after previous immunization with live influenza vaccine
• Other adverse events after immunization (fever above 40°C, syncope, non-febrile convulsions, anaphylaxis) when there is a minimal likelihood that they are associated with a previous administration of any vaccine
• Suspicion of hypersensitivity to any component of the study vaccine, including egg protein

Sponsors & Collaborators

• Tatyana Zubkova: lead
• MDP-CRO, LLC: collaborator
• St. Petersburg State Pavlov Medical University: collaborator

Study Sites (2)

Pavlov First State Medical University of St. Petersburg

Saint Petersburg, Russia

Location

Smorodintsev Research Institute of Influenza

Saint Petersburg, Russia

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of clinical department

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: January 25, 2023
• Study Start: September 13, 2022
• Primary Completion: December 30, 2022
• Study Completion: May 31, 2023
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

RU (2)