Influenza APhase 1NCT04650971
Study to Assess Safety, Tolerability and Reactogenicity of Vaccine "UniFluVec" After Two Intranasal Administrations in Healthy Volunteers
A Phase 1 study testing UniFluVec in people with Influenza A, run by Pharmenterprises Biotech LLC at 1 site in Russia.
Trial summary
A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety, tolerability, reactogenicity and immunogenic activity of the universal influenza vector vaccine "UniFluVec" at two dose levels after two intranasal administrations in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza A
- What is being tested?
- UniFluVec
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 29 Aug 2019to 31 Mar 2020
- Phase
- Phase 1
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Availability of signed informed consent.
- Adult men and women at the age from 18 through 49 years old.
- Diagnosis "healthy", verified by standard examination.
- Body weight ≥ 50 kg.
- The subjects, who are antibody-negative to influenza A/H1N1pdm virus (antibody titers ≤1:10 based on Hemagglutination inhibition assay (HIA)).
- Ability and voluntary desire to keep records in the Self-Observation Diary, as well as to attend all the visits of the study for the medical control.
- Consent of study subjects to use reliable contraception methods during the entire period of their participation in the study, as well as within 3 months after completion of participation in the study.
Who cannot join
- Participation in another clinical study within three months prior to the beginning of this study; plans to participate in another study during the period of this study.
- Immunization with any other vaccine, not provided by the study within 6 months prior to inclusion in this study, or refusal to postpone another immunization until the end of the four-week period after completion of this study.
- Regular administration of irrigation therapy of the nasal cavity within the last six months prior to inclusion in this study or occasional application of this treatment method within two weeks prior to inclusion in this study.
- Frequent nosebleeds within the year before the study in the past medical history (> 5).
- Clinically significant anatomical pathology of the paranasal area or signs of surgical intervention in the area of the nose, sinus sinuses or traumatic injuries of the nose during the month before the beginning of screening.
- Symptoms of acute respiratory disease, including fever, or other acute diseases as of the screening date or within two weeks before the beginning of screening.
Show all 23Show fewer
- Treatment with immunoglobulins or other blood products within three months prior to the beginning of screening or planning such treatment during participation in this study; blood/plasma donation (from 450 ml blood or plasma) in less than 2 months prior to screening.
- The presence or suspicion of various immunosuppressive or immunodeficient conditions or continuous administration (the drug is prescribed for more than 14 days of continous administration) of immunosuppressive drugs, immunomodulators during 6 months before inclusion in this study (for corticosteroids - greater than or equal to 0.5 mg/kg of prednisolone or other equivalent corticosteroids per day; topical and inhaled steroids, except for administration in the nasal cavity, are allowed).
- Participation in any previous studies to assess vaccines containing influenza viruses A/H1N1pdm09.
- Severe allergic reactions, including asthma, Quincke's edema, anaphylactic shock in the past medical history.
- Wheezing after a previous immunization with live influenza vaccine in the past medical history.
- Hypersensitivity after any previous vaccination against influenza and/or adverse effects caused by immunization, like body temperature above 40°C, fainting, non-febrile convulsions, anaphylaxis, when there is a minimal risk of association with the previous administration of any vaccine (not only against influenza).
- Suspected hypersensitivity to any components of the investigated vaccine, including chicken egg protein.
- Seasonal (spring or autumn) hypersensitivity to the natural factor effects.
- Acute or chronic clinically significant lesions in the lungs, the cardiovascular system, liver, endocrine, neurological and psychiatric diseases or renal dysfunction, as revealed based on the past medical history, physical examination or clinical laboratory findings, which may have an impact on the study results.
- Leukemia or any other malignant blood diseases or solid malignant neoplasms of other organs in the past medical history.
- Thrombocytopenic purpura blood-clotting disorders in the past medical history.
- Seizures in the past medical history.
- HIV, hepatitis B or C.
- Tuberculosis.
- Chronic alcohol addiction or chronic use of illegal drugs, drug abuse.
- Pregnancy or breastfeeding.
- Any condition that, according to the researcher, can increase the health risk for the volunteer participating in the study or influence the study results.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal State Budgetary Institution "Research Institute of Influenza" of the Ministry of Health of the Russian Federation
Saint Petersburg
About this study
Official title: Phase I Randomized Double Blind Placebo-controlled Study of Universal Influenza Vector Vaccine "UniFluVec" of Two Dose Levels After Two Intranasal Administrations in Healthy Volunteers at the Age From 18 to 49 Years Old
A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety, tolerability, reactogenicity and immunogenic activity of the universal influenza vector vaccine "UniFluVec" at two dose levels after two intranasal administrations in healthy adults. The volunteers randomized to the study group received intranasally 0.5 ml of the vaccine (0.25 ml in each nostril) as nasal aerosol stray twice with an interval of 3 weeks. The vaccine of the first dose level contained 6.7 log EID50/0.5 ml (50% egg infective dose) of attenuated recombinant influenza A/H1N1pdm09 virus; vaccine of the second dose level contained 7.7 log EID50/0.5 ml of attenuated recombinant influenza A/H1N1pdm09 virus.
The primary objective of the study was to evaluate the safety, tolerability and reactogenicity profile of vaccine "UniFluVec" based on the frequency and severity of adverse events. The secondary objective of the study was to assess the immunogenicity.
Read the detailed description
One center located in Russia (Saint-Petersburg) was approved for participation in this study. The study consisted of 3 periods: screening, double vaccination with an interval of 3 weeks and follow-up.
All eligible subjects were randomized into the study in appropriate cohort groups sequentially. Randomization was performed within each cohort in ratio 2:1 to the vaccine and placebo groups, respectively:
- Cohort 1 (total 30 volunteers) - 20 volunteers received the vaccine twice, 6.7 log EID50/dose; 10 volunteers received Placebo twice.
- Cohort 2 (total 30 volunteers) - 20 volunteers received the vaccine twice, 7.7 log EID50/dose; 10 volunteers received Placebo twice.
The decision to administer the second dose of vaccine or increased vaccine dose (cohort 2) was approved by the Data Safety Monitoring Committee on the basis of preliminary safety results assessment.
The follow-up period lasted 3 months after the second vaccination.
- Conditions
- Influenza A
- Being tested
- UniFluVec, Placebo
- Keywords
- Healthy volunteers, Vector vaccine, UniFluVec
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UniFluVecBiological
Vaccination was performed intranasally (0.25 ml in each nostril) twice with an interval of 3 weeks
PlaceboBiological
Vaccination was performed intranasally (0.25 ml in each nostril) twice with an interval of 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vaccine "UniFluVec" 6.7 log EID50/dose | Experimental | Cohort 1 - 30 subjects were randomized in a 2:1 ratio to be treated either with Vaccine "UniFluVec" 6.7 log EID50/dose (20 subjects) or with placebo (10 subject, see placebo arm). Receives: Biological: UniFluVec |
| Vaccine "UniFluVec" 7.7 log EID50/dose | Experimental | Cohort 2 - 30 subjects were randomized in a 2:1 ratio to be treated either with Vaccine "UniFluVec" 7.7 log EID50/dose (20 subjects) or with placebo (10 subject, see placebo arm). Receives: Biological: UniFluVec |
| Placebo | Placebo comparator | Placebo comparator arm consists of 20 subjects (10 subject in each Сohort). Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse events
Adverse events (AEs) were summarized per treatment arm according to the current Medical Dictionary for Regulatory Activities (medDRA) version 21.1. For each preferred term, frequency counts and percentages were calculated.
Related and unrelated AEs were assessed.
Special attention was paid to vaccine-specific significant AEs:
- Immediate AEs occurring within two hours after administration of the vaccine and detected both by the medical personnel and based on the information provided by the volunteer to the research staff.
- Post-vaccination reactions (foreseen local and systemic clinical signs), usually caused by intranasal vaccination within two hours and the subsequent 7 days after administration of the vaccine.
Measured: Day -7 (7 days before first dose) - Day 111
Secondary outcomes (7)
Assessment of the virus reisolation after the vaccination
This was evaluated according to the diagnostic rapid test for influenza A virus by immunochromatographic method in the nasal swab samples within control periods after vaccination
Measured: Day 2 - Day 5, Day 23, Day 25
The content of serum antibodies
This was evaluated by Hemagglutinin-inhibition assay
Measured: Day 1, Day 21, Day 42
The content of serum neutralizing antibodies
This was evaluated by microneutralization assay
Measured: Day 1, Day 21, Day 42
The content of serum Immunoglobulins class G (IgG)
This was evaluated by enzyme-linked immunosorbent assay (ELISA)
Measured: Day 1, Day 21, Day 42
The content of serum Immunoglobulins class E (IgE)
This was evaluated by ELISA
Measured: Day 1, Day 21, Day 42
Determination of Myxovirus resistance (MxA) protein 1
This was evaluated in the whole blood samples by ELISA
Measured: Day 1, Day 3 (1-st and 3-d days after first vaccination), Day 21, Day 23 (1th and 3th days after second vaccination)
The content of secretory Immunoglobulins class A (IgA) and IgG
This was evaluated by ELISA and microneutralization assay in the samples of nasal secretions.
Measured: Day 1, Day 21, Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start29 Aug 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza AStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The dose cohorts were included into the study based on evaluation of the safety results performed by the Data Safety Monitoring Committee. 2 doses of vaccine/placebo were used in the study. The volunteers randomized to the study group received intranasally 0.5 ml of the vaccine/placebo (0.25 ml in each nostril) as nasal aerosol stray twice with an interval of 3 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmenterprises Biotech LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650971
- Sponsor's protocol ID
- UFV-I-01/2017
- Status last verified
- Nov 2020
- First submitted
- 25 Nov 2020
- Last updated
- 3 Dec 2020
- 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 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Randomized Double Blind Placebo-controlled Study of Universal Influenza Vector Vaccine "UniFluVec" of Two Dose Levels After Two Intranasal Administrations in Healthy Volunteers at the Age From 18 to 49 Years Old
- ClinicalTrials.gov ID
- NCT04650971
- Acronym / sponsor ID
- UFV-I-01/2017
- Conditions
- Influenza A
- Keywords
- Healthy volunteers, Vector vaccine, UniFluVec
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pharmenterprises Biotech LLCUniversity, hospital or other
- Study start
- 29 Aug 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 3 Dec 2020 (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.
A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety, tolerability, reactogenicity and immunogenic activity of the universal influenza vector vaccine "UniFluVec" at two dose levels after two intranasal administrations in healthy adults. The volunteers randomized to the study group received intranasally 0.5 ml of the vaccine (0.25 ml in each nostril) as nasal aerosol stray twice with an interval of 3 weeks. The vaccine of the first dose level contained 6.7 log EID50/0.5 ml (50% egg infective dose) of attenuated recombinant influenza A/H1N1pdm09 virus; vaccine of the second dose level contained 7.7 log EID50/0.5 ml of attenuated recombinant influenza A/H1N1pdm09 virus.
The primary objective of the study was to evaluate the safety, tolerability and reactogenicity profile of vaccine "UniFluVec" based on the frequency and severity of adverse events. The secondary objective of the study was to assess the immunogenicity.
Detailed description
One center located in Russia (Saint-Petersburg) was approved for participation in this study. The study consisted of 3 periods: screening, double vaccination with an interval of 3 weeks and follow-up.
All eligible subjects were randomized into the study in appropriate cohort groups sequentially. Randomization was performed within each cohort in ratio 2:1 to the vaccine and placebo groups, respectively:
- Cohort 1 (total 30 volunteers) - 20 volunteers received the vaccine twice, 6.7 log EID50/dose; 10 volunteers received Placebo twice.
- Cohort 2 (total 30 volunteers) - 20 volunteers received the vaccine twice, 7.7 log EID50/dose; 10 volunteers received Placebo twice.
The decision to administer the second dose of vaccine or increased vaccine dose (cohort 2) was approved by the Data Safety Monitoring Committee on the basis of preliminary safety results assessment.
The follow-up period lasted 3 months after the second vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- The dose cohorts were included into the study based on evaluation of the safety results performed by the Data Safety Monitoring Committee. 2 doses of vaccine/placebo were used in the study. The volunteers randomized to the study group received intranasally 0.5 ml of the vaccine/placebo (0.25 ml in each nostril) as nasal aerosol stray twice with an interval of 3 weeks.
| Arm | Type | Receives |
|---|---|---|
| Vaccine "UniFluVec" 6.7 log EID50/dose | Experimental | Biological: UniFluVecCohort 1 - 30 subjects were randomized in a 2:1 ratio to be treated either with Vaccine "UniFluVec" 6.7 log EID50/dose (20 subjects) or with placebo (10 subject, see placebo arm). |
| Vaccine "UniFluVec" 7.7 log EID50/dose | Experimental | Biological: UniFluVecCohort 2 - 30 subjects were randomized in a 2:1 ratio to be treated either with Vaccine "UniFluVec" 7.7 log EID50/dose (20 subjects) or with placebo (10 subject, see placebo arm). |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo comparator arm consists of 20 subjects (10 subject in each Сohort). |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Availability of signed informed consent.
- Adult men and women at the age from 18 through 49 years old.
- Diagnosis "healthy", verified by standard examination.
- Body weight ≥ 50 kg.
- The subjects, who are antibody-negative to influenza A/H1N1pdm virus (antibody titers ≤1:10 based on Hemagglutination inhibition assay (HIA)).
Key exclusion criteria (23 listed)
- Participation in another clinical study within three months prior to the beginning of this study; plans to participate in another study during the period of this study.
- Immunization with any other vaccine, not provided by the study within 6 months prior to inclusion in this study, or refusal to postpone another immunization until the end of the four-week period after completion of this study.
- Regular administration of irrigation therapy of the nasal cavity within the last six months prior to inclusion in this study or occasional application of this treatment method within two weeks prior to inclusion in this study.
- Frequent nosebleeds within the year before the study in the past medical history (> 5).
- Clinically significant anatomical pathology of the paranasal area or signs of surgical intervention in the area of the nose, sinus sinuses or traumatic injuries of the nose during the month before the beginning of 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 |
|---|---|---|
| UniFluVecVaccination was performed intranasally (0.25 ml in each nostril) twice with an interval of 3 weeks | Biological | Vaccine "UniFluVec" 6.7 log EID50/dose, Vaccine "UniFluVec" 7.7 log EID50/dose |
| PlaceboVaccination was performed intranasally (0.25 ml in each nostril) twice with an interval of 3 weeks | Biological | Placebo |
Primary outcome
Number of Adverse events
Time frame: Day -7 (7 days before first dose) - Day 111
Adverse events (AEs) were summarized per treatment arm according to the current Medical Dictionary for Regulatory Activities (medDRA) version 21.1. For each preferred term, frequency counts and percentages were calculated. Related and unrelated AEs were assessed. Special attention was paid to vaccine-specific significant AEs: * Immediate AEs occurring within two hours after administration of the vaccine and detected both by the medical personnel and based on the information provided by the volunteer to the research staff. * Post-vaccination reactions (foreseen local and systemic clinical signs), usually caused by intranasal vaccination within two hours and the subsequent 7 days after administration of the vaccine.
7 secondary outcomes
Assessment of the virus reisolation after the vaccination
Time frame: Day 2 - Day 5, Day 23, Day 25
The content of serum antibodies
Time frame: Day 1, Day 21, Day 42
The content of serum neutralizing antibodies
Time frame: Day 1, Day 21, Day 42
The content of serum Immunoglobulins class G (IgG)
Time frame: Day 1, Day 21, Day 42
The content of serum Immunoglobulins class E (IgE)
Time frame: Day 1, Day 21, Day 42
Determination of Myxovirus resistance (MxA) protein 1
Time frame: Day 1, Day 3 (1-st and 3-d days after first vaccination), Day 21, Day 23 (1th and 3th days after second vaccination)
The content of secretory Immunoglobulins class A (IgA) and IgG
Time frame: Day 1, Day 21, Day 42
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 3 Dec 2020.
Related trials for Influenza A
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
Seasonal Influenza
RecruitingPhase 1
A Trial to Evaluate the Effect of CD388/MK1406 on the Immunogenicity of Fluzone® HD Vaccine (CD388.SQ.1.08/MK-1406-007)
Healthy Participants
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UniFluVec in people with Influenza A, run by Pharmenterprises Biotech LLC at 1 site 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 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: finished, as of the sponsor's last update on 3 Dec 2020. 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 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 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.
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 Adverse events (time frame: Day -7 (7 days before first dose) - Day 111). 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 3 Dec 2020.