Healthy VolunteersPhase 2NCT04034290
A Double-blind Randomized Placebo-controlled Study Study of the Safety, Reactogenicity and Immunogenicity of the GamFluVac
A Phase 2 study testing GamFluVac in people with Healthy Volunteers, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 1 site in Russia.
Trial summary
The aim of the present study is at the first stage: a comparative assessment of the safety of the two methods of vaccine administration, at the second - an assessment of the safety and state of post-vaccination immunity at different times after vaccination Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- GamFluVac
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 1 siteRussia
- Study dates
- 18 Oct 2019to 31 Jul 2020
- Phase
- Phase 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged 18 to 55 years old.
- Written informed consent.
- consent to the use of effective contraceptive methods throughout the study period *
- using one of the following methods: abstinence, condoms (male or female with or without spermicide), diaphragm or cervical cap with spermicide, intrauterine device
- body mass index (BMI) from 18.5 to 30.
- absence of acute infectious diseases or exacerbation of chronic infections at the time of vaccination and 7 days before vaccination;
Show all 20Show fewer
- absence of allergic diseases of a serious degree (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, serum sickness)
- absence of strong post-vaccination reactions or post-vaccination complications for previous use of immunobiological drugs;
- absence of 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;
- negative pregnancy test (for fertile women);
- negative tests for HIV, hepatitis B and C, syphilis;
- negative urine test for traces of drugs;
- negative test for alcohol content in the exhaled air;
- absence of malignant blood diseases;
- absence of malignant neoplasms;
- indicators of the total blood test at the screening not higher/lower than 1.1 x LLN/ULN (upper/lower limit of the normal reference range) *;
- normal reference values of the laboratory performing the studies must be provided before the volunteer screening begins
- according to the biochemical blood test at the screening: the level of urea, creatinine, alanine aminotransferase, aspartate aminotransferase, glucose, creatine phosphokinase, total protein, bilirubin, glucose, LDH, alkaline phosphatase, LDL / HDL / VLDL - no higher/lower 1.1 X LLN/ULN (upper/lower limit of the normal reference range), total cholesterol level from 3,6 mmol/l to 7,8 mmol/l;
- no changes in myocardium of inflammatory or dystrophic nature according to ECG results at screening;
- lack of vaccination against influenza within 6 months before the start of the study (including during participation in other clinical trials).
Who cannot join
- participation of a volunteer in any other study in the last 90 days;
- any vaccination in the last 30 days;
- vaccination against influenza 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;
- recent frequent nasal bleeding (> 5 last year);
- chronic rhinitis, the presence of defects of the nasal septum, polyps of the nose or other significant anomalies;
Show all 22Show fewer
- surgical operations or a history of nasal trauma for 6 months.
- treatment with steroids in the last 10 days;
- 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;
- regular past or current use of narcotic drugs;
- pregnancy or breastfeeding;
- systolic blood pressure less than 100 mmHg or higher than 139 mmHg; diastolic blood pressure less than 60 mmHg. or above 90 mmHg; the heart rate is less than 60 beats per minute or more than 90 beats per minute;
- exacerbation of allergic diseases, the presence of anaphylactic reactions or angioedema in medical history;
- hypersensitivity or allergic reactions to the administration of any vaccine in medical history;
- allergic reactions to vaccine components;
- diabetes mellitus or other forms of impaired glucose tolerance;
- the presence of a concomitant disease that may influence the evaluation of the results of the study: active forms of tuberculosis, chronic liver and kidney diseases, severe thyroid dysfunction and other endocrine system diseases (diabetes mellitus), severe deseases of hematopoietic system, epilepsy and other CNS diseases, myocardial infarction, myocarditis, endocarditis, pericarditis, coronary heart disease, autoimmune pathology, serious chronic diseases requiring a hospitalisation;
- donor blood donation (450 ml and more blood or plasma) less than 2 months before the start of the study;
- taking a history of more than 5 units of alcohol (equal 0.25 liters of ethanol) per week;
- smoking: more than 10 cigarettes a day;
- planned hospitalization and / or surgical intervention during the study period, and 4 weeks before the expected date of vaccination.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal state budgetary institution " Main military clinical hospital named after academician N. N. Burdenko " of the Ministry of Defence of the Russian Federation
Moscow
About this study
Official title: A Double-blind Randomized Placebo-controlled Study of Safety and Immunogenicity of Medicinal Product With a Period of Open Safety Assessment in Two Modes of Administration, in Healthy Volunteers
The aim of the present study is at the first stage: a comparative assessment of the safety of the two methods of vaccine administration, at the second - an assessment of the safety and state of post-vaccination immunity at different times after vaccination
Read the detailed description
In the first stage estimate of safety of vaccine after its single administration to the nasal cavity by the drip method or by spray - dispenser during the period of observation in 30 days with the participation of 24 volunteers, divided into 2 groups of 12 people for each method of administration
After interim analysis of safety data is subject to the consent of the local ethics Committee of the Research Centre about the possibility of further studies of the drug - will be started the second phase of the study, which, along with continued security research, provides the definition of the parameters of immunogenicity of the study drug. The second phase of the study will included 200 participants, including 100 people will receive the study drug and 100 will be a control group of observation - that is, will get a placebo.
- Conditions
- Healthy Volunteers
- Being tested
- GamFluVac, Placebo
- Keywords
- influenza, vaccine, Immunologic Factors, Respiratory Tract Infections, vector vaccines
- Medical subject headings
- Influenza, Human, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GamFluVacBiological
The drug is a vaccine that induces high-level immunity against influenza A viruses
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 (GamFluVac intranasal drip) | Experimental | The total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) × 1011 VP/dose administrated by intranasal drip Receives: Biological: GamFluVac |
| Stage 1 (GamFluVac with the help of a spray dispenser) | Experimental | The total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) × 1011 VP/dose administrated intranasally with the help of a spray dispenser Receives: Biological: GamFluVac |
| Stage 2 Vaccine | Experimental | The total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) × 1011 VP/dose Receives: Biological: GamFluVac |
| Stage 2 (Controll Group) | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Determination of Number of Participants With Adverse Events
Measured: through the whole study, an average of 180 days
Antibody levels a measured by an enzyme-linked immunosorbent assay (ELISA)
Determination of antibody levels measured by an ELISA vs. baseline values and vs placebo
Measured: through the whole study, an average of 90 days
Secondary outcomes (1)
Assessment of antigen-specific cell-mediated immune response
determination of specific T-cell- mediated response vs. baseline values ans vs placebo
Measured: at days 0 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start18 Oct 2019
- Primary completion30 Jun 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
- Sponsor type
- University, hospital or other
- Collaborators
- Main military clinical hospital named after academician N. N. Burdenko
- Responsible party
- Sponsor
- Investigators
- Irina Gagarina, MD, PhD, Principal investigator, Federal state budgetary institution " Main military clinical hospital named after academician N. N. Burdenko " of the Ministry of Defence of the Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034290
- Sponsor's protocol ID
- 03 - GamFluVac-2019
- Status last verified
- Jul 2019
- First submitted
- 24 Jul 2019
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized Placebo-controlled Study of Safety and Immunogenicity of Medicinal Product With a Period of Open Safety Assessment in Two Modes of Administration, in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04034290
- Acronym / sponsor ID
- 03 - GamFluVac-2019
- Conditions
- Healthy Volunteers
- Keywords
- influenza, vaccine, Immunologic Factors, Respiratory Tract Infections, vector vaccines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Collaborators
- Main military clinical hospital named after academician N. N. Burdenko
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 26 Jul 2019 (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 present study is at the first stage: a comparative assessment of the safety of the two methods of vaccine administration, at the second - an assessment of the safety and state of post-vaccination immunity at different times after vaccination
Detailed description
In the first stage estimate of safety of vaccine after its single administration to the nasal cavity by the drip method or by spray - dispenser during the period of observation in 30 days with the participation of 24 volunteers, divided into 2 groups of 12 people for each method of administration
After interim analysis of safety data is subject to the consent of the local ethics Committee of the Research Centre about the possibility of further studies of the drug - will be started the second phase of the study, which, along with continued security research, provides the definition of the parameters of immunogenicity of the study drug. The second phase of the study will included 200 participants, including 100 people will receive the study drug and 100 will be a control group of observation - that is, will get a placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stage 1 (GamFluVac intranasal drip) | Experimental | Biological: GamFluVacThe total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) × 1011 VP/dose administrated by intranasal drip |
| Stage 1 (GamFluVac with the help of a spray dispenser) | Experimental | Biological: GamFluVacThe total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) × 1011 VP/dose administrated intranasally with the help of a spray dispenser |
| Stage 2 Vaccine | Experimental | Biological: GamFluVacThe total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) × 1011 VP/dose |
| Stage 2 (Controll Group) | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Men and women aged 18 to 55 years old.
- Written informed consent.
- consent to the use of effective contraceptive methods throughout the study period *
- body mass index (BMI) from 18.5 to 30.
- absence of acute infectious diseases or exacerbation of chronic infections at the time of vaccination and 7 days before vaccination;
Key exclusion criteria (22 listed)
- participation of a volunteer in any other study in the last 90 days;
- any vaccination in the last 30 days;
- vaccination against influenza 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;
- recent frequent nasal bleeding (> 5 last year);
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 |
|---|---|---|
| GamFluVacThe drug is a vaccine that induces high-level immunity against influenza A viruses | Biological | Stage 1 (GamFluVac intranasal drip), Stage 1 (GamFluVac with the help of a spray dispenser), Stage 2 Vaccine |
| PlaceboPlacebo | Other | Stage 2 (Controll Group) |
Primary outcome
Number of Participants With Adverse Events
Time frame: through the whole study, an average of 180 days
Determination of Number of Participants With Adverse Events
Antibody levels a measured by an enzyme-linked immunosorbent assay (ELISA)
Time frame: through the whole study, an average of 90 days
Determination of antibody levels measured by an ELISA vs. baseline values and vs placebo
1 secondary outcome
Assessment of antigen-specific cell-mediated immune response
Time frame: at days 0 and 7
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 25 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
RecruitingEarly Phase 1
Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers
Irritability
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.
Irina Gagarina, MD, PhD principal investigator
Federal state budgetary institution " Main military clinical hospital named after academician N. N. Burdenko " of the Ministry of Defence of the Russian Federation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GamFluVac in people with Healthy Volunteers, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation 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 20 inclusion and 22 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 25 Aug 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 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 Adverse Events (time frame: through the whole study, an average of 180 days). The study lists 2 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 25 Aug 2020.