COVID-19Phase 1/2NCT05696067
Evaluation of Corfluvec Vaccine for the Prevention of COVID-19 in Healthy Volunteers
A Phase 1/2 study testing Corfluvec component 1 low dose, Corfluvec component 2 low dose and Corfluvec component 1 high dose in people with COVID-19, run by Tatyana Zubkova at 2 sites in Russia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Corfluvec component 1 low dose, Corfluvec component 2 low dose and Corfluvec component 1 high dose
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesRussia
- Study dates
- 13 Sep 2022to 31 May 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- Seasonal (in spring or autumn) increased sensitivity to the effects of natural factors
- Acute or chronic clinically significant lung, cardiovascular, hepatic, endocrine, neurological, or psychiatric disorders, or impaired renal function identified by history, physical examination, or clinical laboratory findings that, in the opinion of the investigator, may influence the outcome of the study
- History of leukemia or any other malignant diseases of the blood or solid malignant neoplasms of other organs
- History of thrombocytopenic purpura or bleeding disorders
- History of convulsions
- The presence or suspicion of the presence of various immunosuppressive or immunodeficiency conditions, including HIV infection
- Tuberculosis or residual changes after tuberculosis according to the anamnesis and / or available medical documentation
- Chronic alcohol dependence or chronic use of illicit drugs, drug abuse
- Claustrophobia and social phobia according to history and / or available medical records
- For women of reproductive age - lactation, pregnancy or suspected pregnancy, early postpartum period
- Premenopausal women (last menstrual period <1 year prior to signing informed consent) who are not surgically sterile and women who are of reproductive potential but do not use or plan to use valid birth control throughout the study and do not agree to perform a urine pregnancy test while participating in the study
- Military personnel undergoing military service on conscription
- Persons in custody in pre-trial detention centers and serving sentences in places of deprivation of liberty
- Special diet (eg, vegetarian, vegan, salt-restricted) or lifestyle (night work, extreme physical activity)
- Any condition that, in the opinion of the investigator, may increase the risk to the health of a volunteer participating in the study or affect the results of the study
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Pavlov First State Medical University of St. Petersburg
Saint Petersburg
Smorodintsev Research Institute of Influenza
Saint Petersburg
About this study
Official title: Randomized, Double-blind, Placebo-controlled Phase 1/2 Trial of Corfluvec Intranasal Vector Vaccine for the Prevention of COVID-19 in Healthy Volunteers Aged 18 to 60 Years
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
Read the detailed description
Study include three parts. During the first part the two vaccine components will be administered separately to a small number of seronegative participants in low dose and then high dose to evaluate each component's safety. During the second part vaccine components would be administered one after another with 21 days interval to evaluate safety of the complete vaccine regimen (low dose and high dose). During the third part of the study the high dose vaccine will be administered to participants to evaluate vaccine immunogenicity. The whole study will include 200 participants. Duration of the study for each participant is about 6.5 months (no more than 194 days).
- Conditions
- COVID-19
- Being tested
- Corfluvec component 1 low dose, Corfluvec component 2 low dose, Corfluvec component 1 high dose, Corfluvec component 2 high dose, Corfluvec low dose
- Keywords
- COVID-19, vaccine, influenza vector
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corfluvec component 1 low doseBiological
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
Corfluvec component 2 low doseBiological
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
Corfluvec component 1 high doseBiological
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
Corfluvec component 2 high doseBiological
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
Corfluvec low doseBiological
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)
Corfluvec high doseBiological
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)
PlaceboBiological
Participants will receive two intranasal injections of placebo three weeks apart
| Study group | Role | What they receive |
|---|---|---|
| Group 0a | Experimental | Single dose of 7.2 lg EID50 of H3N2 vaccine component Receives: Biological: Corfluvec component 1 low dose |
| Group 0b | Experimental | Single dose of 7.5 lg EID50 of H1N1pdm09 vaccine component Receives: Biological: Corfluvec component 2 low dose |
| Group 0c | Experimental | Single dose of 8.0 lg EID50 of H3N2 vaccine component Receives: Biological: Corfluvec component 1 high dose |
| Group 0d | Experimental | Single dose of 8.3 lg EID50 of H1N1pdm09 vaccine component Receives: Biological: Corfluvec component 2 high dose |
| Group 1a | Experimental | Low dose vaccine, two components received three weeks apart Receives: Biological: Corfluvec low dose |
| Group 1b | Experimental | High dose vaccine, two components received three weeks apart Receives: Biological: Corfluvec high dose |
| Group 1c | Placebo comparator | Placebo, two doses received three weeks apart Receives: Biological: Placebo |
| Group 2a | Experimental | High dose vaccine, two components received three weeks apart Receives: Biological: Corfluvec high dose |
| Group 2b | Placebo comparator | Placebo, two doses received three weeks apart Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Proportion of participants exhibiting significant increase in the level of specific T-cell response to SARS-CoV-2 N protein after vaccination in comparison to baseline. The increase in the parameter is considered significant if it exceeds the specified range, which is a 95% CI for mean value of parameter fold change in the Placebo group at assessment day compared to Day 1
Measured: Days 7, 21, 27, 42±2
Seroconversion rate of SARS-CoV-2 antigen specific antibody
Proportion of participants who have at least a 4-fold increase in post-vaccination antibody titers in comparison to baseline
Measured: Days 21, 42±2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start13 Sep 2022
- Primary completion30 Dec 2022
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tatyana Zubkova
- Sponsor type
- University, hospital or other
- Collaborators
- MDP-CRO, LLC, St. Petersburg State Pavlov Medical University
- Responsible party
- Sponsor-investigator, Tatyana Zubkova, Research Institute of Influenza, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696067
- Sponsor's protocol ID
- KFV-I/II-01/2022
- Status last verified
- Apr 2024
- First submitted
- 17 Jan 2023
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Phase 1/2 Trial of Corfluvec Intranasal Vector Vaccine for the Prevention of COVID-19 in Healthy Volunteers Aged 18 to 60 Years
- ClinicalTrials.gov ID
- NCT05696067
- Acronym / sponsor ID
- KFV-I/II-01/2022
- Conditions
- COVID-19
- Keywords
- COVID-19, vaccine, influenza vector
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Tatyana ZubkovaUniversity, hospital or other
- Collaborators
- MDP-CRO, LLC, St. Petersburg State Pavlov Medical University
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Study include three parts. During the first part the two vaccine components will be administered separately to a small number of seronegative participants in low dose and then high dose to evaluate each component's safety. During the second part vaccine components would be administered one after another with 21 days interval to evaluate safety of the complete vaccine regimen (low dose and high dose). During the third part of the study the high dose vaccine will be administered to participants to evaluate vaccine immunogenicity. The whole study will include 200 participants. Duration of the study for each participant is about 6.5 months (no more than 194 days).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Group 0a | Experimental | Biological: Corfluvec component 1 low doseSingle dose of 7.2 lg EID50 of H3N2 vaccine component |
| Group 0b | Experimental | Biological: Corfluvec component 2 low doseSingle dose of 7.5 lg EID50 of H1N1pdm09 vaccine component |
| Group 0c | Experimental | Biological: Corfluvec component 1 high doseSingle dose of 8.0 lg EID50 of H3N2 vaccine component |
| Group 0d | Experimental | Biological: Corfluvec component 2 high doseSingle dose of 8.3 lg EID50 of H1N1pdm09 vaccine component |
| Group 1a | Experimental | Biological: Corfluvec low doseLow dose vaccine, two components received three weeks apart |
| Group 1b | Experimental | Biological: Corfluvec high doseHigh dose vaccine, two components received three weeks apart |
| Group 1c | Placebo comparator | Biological: PlaceboPlacebo, two doses received three weeks apart |
| Group 2a | Experimental | Biological: Corfluvec high doseHigh dose vaccine, two components received three weeks apart |
| Group 2b | Placebo comparator | Biological: PlaceboPlacebo, two doses received three weeks apart |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corfluvec component 1 low doseParticipants 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 | Biological | Group 0a |
| Corfluvec component 2 low doseParticipants 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 | Biological | Group 0b |
| Corfluvec component 1 high doseParticipants 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 | Biological | Group 0c |
| Corfluvec component 2 high doseParticipants 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 | Biological | Group 0d |
| Corfluvec low doseParticipants 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) | Biological | Group 1a |
| Corfluvec high doseParticipants 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) | Biological | Group 1b, Group 2a |
| PlaceboParticipants will receive two intranasal injections of placebo three weeks apart | Biological | Group 1c, Group 2b |
Primary outcome
Number of participants with local and systemic adverse events (AEs) and serious adverse events (SAEs)
Time frame: Throughout the study, average of 6.5 months
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
Level of SARS-CoV-2 antigen specific cytokine producing T-cells
Time frame: Throughout the 42±2 study days
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
Level of SARS-CoV-2 antigen specific cytokine release in whole blood assay
Time frame: Throughout the 42±2 study days
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
Level of SARS-CoV-2 antigen specific mucosal and systemic IgA and IgG antibody
Time frame: Throughout the 42±2 study days
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
2 secondary outcomes
Number of responders to vaccination according to the fold increase in the level of specific T-cell response
Time frame: Days 7, 21, 27, 42±2
Seroconversion rate of SARS-CoV-2 antigen specific antibody
Time frame: Days 21, 42±2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Corfluvec component 1 low dose, Corfluvec component 2 low dose and Corfluvec component 1 high dose in people with COVID-19, run by Tatyana Zubkova at 2 sites in Russia.
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 11 inclusion and 30 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: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with local and systemic adverse events (AEs) and serious adverse events (SAEs) (time frame: Throughout the study, average of 6.5 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2024.