Safety IssuesPhase 1NCT03789539
Reactogenicity, Safety and Immunogenicity of an Universal Influenza Vaccine Uniflu
A Phase 1 study testing LD Universal Influenza Vaccine Uniflu and HD Universal Influenza Vaccine Uniflu in people with Safety Issues, run by VA Pharma Limited Liability Company at 1 site in Russia.
Trial summary
This is a single-site, randomized, double-blind, placebo-controlled study of Uniflu in fifty four (54) volunteers 18-60 years of age with a dose escalation. All subjects will receive an intramuscular (IM) injection twice,with a 21 days interval between treatments. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- What is being tested?
- LD Universal Influenza Vaccine Uniflu and HD Universal Influenza Vaccine Uniflu
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteRussia
- Study dates
- 2 Jun 2018to 31 Dec 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged 18 to 60 years old.
- Healthy that verificated by vital signs, physical examination, blood and urine lab tests
- Body mass index (BMI) from 18.5 to 30.5 weight >50 kg
- Written informed consent.
- Consent to the use of effective contraceptive methods throughout the study period.
- Negative pregnancy test (for fertile women), consent to the use of effective contraceptive methods throughout the study period.
Who cannot join
- Participation of a volunteer in any other study in the last 90 days; any vaccination in the last 30 days;
- Vaccination within 6 months before the start of the study (including during participation in other clinical trials).
- Symptoms of respiratory illness in the last 3 days.
- Symptoms of any acute in the screening period.
- Administration of immunoglobulins or other blood products for the last 3 months.
- Taking immunosuppressive drugs and / or immunomodulators within 6 months before the start of the study.
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- Hypersensitivity or allergic reactions to the administration of any vaccine in medical history.
- The presence of anaphylactic reactions, angioedema or other SAE to the administration of any vaccine in medical history.
- Allergic reactions to vaccine components.
- Seasonal allergy (at autumn period).
- Acute or chronical desease or pathology from the gastrointestinal tract, liver, kidneys, cardiovascular system, central nervous system, musculoskeletal system, genitourinary and endocrine systems, which may influence the evaluation of the results of the study, in the anamnesis and also according to the screening examination data
- Leukemia or any other blood disease or malignancy of other organs.
- Thrombocytopenic purpura or bleeding disorders in medical history.
- Seizures in medical history.
- The presence or suspected presence of various immunosuppressive or immunodeficient state, including HIV infection.
- Hepatitis B and C.
- Tuberculosis.
- Regular past or current use of narcotic drugs.
- Pregnancy or breastfeeding.
- Any conditions which may influence the evaluation of the results of the study, in the anamnesis and also according to the screening examination data.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Research Institute of Influenza
Saint Petersburg, Sankt-Peterburg, 197376
About this study
Official title: Reactogenicity, Safety and Immunogenicity of an Recombinant Universal Influenza Vaccine Uniflu in Healthy Volunteers From 18 to 60 Years Old
This is a single-site, randomized, double-blind, placebo-controlled study of Uniflu in fifty four (54) volunteers 18-60 years of age with a dose escalation.
All subjects will receive an intramuscular (IM) injection twice,with a 21 days interval between treatments.
Read the detailed description
This is a single-site, randomized, double-blind, placebo-controlled study of Uniflu in fifty four (54) volunteers 18-60 years of age.
All subjects will receive an intramuscular (IM) injection twice,with a 21 days interval between treatments.
Subjects will undergo screening procedures within 6 days prior to first vaccination which will include medical history, vital signs, physical examination and safety blood and urine lab tests.
On the first treatment visit, eligible subjects will undergo pre-dose physical examination,vital signs, ECG, a blood sample will be drawn for circulating IgE. They receive an IM injection of either vaccine or placebo, according to the above treatment assignment, into the deltoid muscle. The subjects will remain under medical supervision for 72 hrs, after that time they will be released from the Clinical research center.
The second treatment will take place 21 days after the first vaccination. Procedures will be the same as on the first treatment visit.
Follow-up visits take place at 4th, 5th, 6th, 14th, 35th days. A Study Termination visit will take place at 42nd day of research. Adverse events (AEs) and changes in concomitant medications will be recorded, vital signs will be measured and the subjects will undergo physical examination and ECG. Blood and urine samples will be collected for safety.
- Conditions
- Safety Issues
- Being tested
- LD Universal Influenza Vaccine Uniflu, HD Universal Influenza Vaccine Uniflu, Placebo
- Keywords
- Safety, Reactogenicity, Universal Influenza Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LD Universal Influenza Vaccine UnifluBiological
low dose Universal Influenza Vaccine Uniflu
HD Universal Influenza Vaccine UnifluBiological
High dose Universal Influenza Vaccine Uniflu
PlaceboBiological
Placebo saline
| Study group | Role | What they receive |
|---|---|---|
| LD Universal Influenza Vaccine Uniflu | Active comparator | low dose of Uniflu vaccine 0.5 ml (20 mkg of recombinant protein HBc-4M2eh) administrated intramuscularly 2 times at 21 days intervals Receives: Biological: LD Universal Influenza Vaccine Uniflu |
| HD Universal Influenza Vaccine Uniflu | Active comparator | high dose of Uniflu vaccine 0.5 ml (40 mkg of recombinant protein HBc-4M2eh) administrated intramuscularly 2 times at 21 days intervals Receives: Biological: HD Universal Influenza Vaccine Uniflu |
| Placebo | Placebo comparator | saline 0.5 ml Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events in treatment vs control group
Estimation the quantity of adverse events in treatment group vs control group
Measured: 42 days (from first visit to termination visit for each subject)
Secondary outcomes (1)
Assessment of Immunogenicity
Determination of antibody levels of IgG to M2e protein measured by IFA vs. baseline values
Measured: Time Frame: at days 1, 21, 42.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start2 Jun 2018
- Primary completion2 Dec 2018
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies 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
- Parallel groups
- Model description
- Subjects will undergo screening procedures within 2-6 days prior to first vaccination which will include medical history, vital signs, physical examination and safety blood and urine lab tests. On the first treatment visit, eligible subjects will undergo pre-dose physical examination, ECG, vital signs, and a blood sample for circulating IgE. They will then receive an IM injection of either vaccine or placebo, according to the above treatment assignment, into the deltoid muscle preferably of non dominant arm. The subjects will remain under medical supervision for 72 hrs at which time they will be released from the Clinical research center. The second treatment will take place 21 days after the first vaccination. Procedures will be the same as that of Visit 1 Additional follow-up visits will take place at 4-7th,14th,24-27th and 42nd days. Blood and urine samples will be collected for safety.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Pharma Limited Liability Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julia M Savateeva, PhD, Study director, VA Pharma Limited Liability Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789539
- Sponsor's protocol ID
- UIV-I-01/2017
- Status last verified
- Dec 2018
- First submitted
- 24 Dec 2018
- Last updated
- 28 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reactogenicity, Safety and Immunogenicity of an Recombinant Universal Influenza Vaccine Uniflu in Healthy Volunteers From 18 to 60 Years Old
- ClinicalTrials.gov ID
- NCT03789539
- Acronym / sponsor ID
- UIV-I-01/2017
- Conditions
- Safety Issues
- Keywords
- Safety, Reactogenicity, Universal Influenza Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (actual)
- Lead sponsor
- VA Pharma Limited Liability CompanyIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2018 (actual)
- Primary completion
- 2 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 28 Dec 2018 (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.
This is a single-site, randomized, double-blind, placebo-controlled study of Uniflu in fifty four (54) volunteers 18-60 years of age with a dose escalation.
All subjects will receive an intramuscular (IM) injection twice,with a 21 days interval between treatments.
Detailed description
This is a single-site, randomized, double-blind, placebo-controlled study of Uniflu in fifty four (54) volunteers 18-60 years of age.
All subjects will receive an intramuscular (IM) injection twice,with a 21 days interval between treatments.
Subjects will undergo screening procedures within 6 days prior to first vaccination which will include medical history, vital signs, physical examination and safety blood and urine lab tests.
On the first treatment visit, eligible subjects will undergo pre-dose physical examination,vital signs, ECG, a blood sample will be drawn for circulating IgE. They receive an IM injection of either vaccine or placebo, according to the above treatment assignment, into the deltoid muscle. The subjects will remain under medical supervision for 72 hrs, after that time they will be released from the Clinical research center.
The second treatment will take place 21 days after the first vaccination. Procedures will be the same as on the first treatment visit.
Follow-up visits take place at 4th, 5th, 6th, 14th, 35th days. A Study Termination visit will take place at 42nd day of research. Adverse events (AEs) and changes in concomitant medications will be recorded, vital signs will be measured and the subjects will undergo physical examination and ECG. Blood and urine samples will be collected for safety.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects will undergo screening procedures within 2-6 days prior to first vaccination which will include medical history, vital signs, physical examination and safety blood and urine lab tests. On the first treatment visit, eligible subjects will undergo pre-dose physical examination, ECG, vital signs, and a blood sample for circulating IgE. They will then receive an IM injection of either vaccine or placebo, according to the above treatment assignment, into the deltoid muscle preferably of non dominant arm. The subjects will remain under medical supervision for 72 hrs at which time they will be released from the Clinical research center. The second treatment will take place 21 days after the first vaccination. Procedures will be the same as that of Visit 1 Additional follow-up visits will take place at 4-7th,14th,24-27th and 42nd days. Blood and urine samples will be collected for safety.
| Arm | Type | Receives |
|---|---|---|
| LD Universal Influenza Vaccine Uniflu | Active comparator | Biological: LD Universal Influenza Vaccine Uniflulow dose of Uniflu vaccine 0.5 ml (20 mkg of recombinant protein HBc-4M2eh) administrated intramuscularly 2 times at 21 days intervals |
| HD Universal Influenza Vaccine Uniflu | Active comparator | Biological: HD Universal Influenza Vaccine Unifluhigh dose of Uniflu vaccine 0.5 ml (40 mkg of recombinant protein HBc-4M2eh) administrated intramuscularly 2 times at 21 days intervals |
| Placebo | Placebo comparator | Biological: Placebosaline 0.5 ml |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Men and women aged 18 to 60 years old.
- Healthy that verificated by vital signs, physical examination, blood and urine lab tests
- Body mass index (BMI) from 18.5 to 30.5 weight >50 kg
- Written informed consent.
- Consent to the use of effective contraceptive methods throughout the study period.
Key exclusion criteria (20 listed)
- Participation of a volunteer in any other study in the last 90 days; any vaccination in the last 30 days;
- Vaccination within 6 months before the start of the study (including during participation in other clinical trials).
- Symptoms of respiratory illness in the last 3 days.
- Symptoms of any acute in the screening period.
- Administration of immunoglobulins or other blood products for the last 3 months.
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 |
|---|---|---|
| LD Universal Influenza Vaccine Uniflulow dose Universal Influenza Vaccine Uniflu | Biological | LD Universal Influenza Vaccine Uniflu |
| HD Universal Influenza Vaccine UnifluHigh dose Universal Influenza Vaccine Uniflu | Biological | HD Universal Influenza Vaccine Uniflu |
| PlaceboPlacebo saline | Biological | Placebo |
Primary outcome
Number of participants with adverse events in treatment vs control group
Time frame: 42 days (from first visit to termination visit for each subject)
Estimation the quantity of adverse events in treatment group vs control group
1 secondary outcome
Assessment of Immunogenicity
Time frame: Time Frame: at days 1, 21, 42.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
Julia M Savateeva, PhD study director
VA Pharma Limited Liability Company
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 LD Universal Influenza Vaccine Uniflu and HD Universal Influenza Vaccine Uniflu in people with Safety Issues, run by VA Pharma Limited Liability Company 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 6 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 28 Dec 2018. 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?
Results are not available in the source record.
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 adverse events in treatment vs control group (time frame: 42 days (from first visit to termination visit for each subject)). 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 28 Dec 2018.