Influenza A Virus InfectionPhase 1NCT03651544

The Study of the Safety, Reactogenicity and Immunogenicity of the GamFluVac

A Phase 1 study testing GamFluVac in people with Influenza A Virus Infection and Influenza A, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The present clinical phase I study designed to examine the safety, reactogenicity and immunogenicity of the medicinal product - Vaccine vector against influenza A - in healthy volunteers after a single dose in the three groups with dose escalation. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Influenza A Virus Infection, Influenza A, Influenza Epidemic
What is being tested?: GamFluVac
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteRussia
Study dates: 15 Oct 2018to 14 Mar 2019
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 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;

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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;

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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 diseases 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, 141306

Other trials in Russia

About this study

Official title: An Open Study of the Safety, Reactogenicity and Immunogenicity of the GamFluVac Vector Vaccine Against Influenza A in Healthy Volunteers in 3 Groups With a Dose Escalation

Read the detailed description

According to the results of the screening of volunteers who signed the informed consent Form, a sequential set of three groups of volunteers with different doses of the drug, the total number of volunteers who received the drug will be at least 36 people.

Given the fact that the drug is investigated for the first time with the participation of the people, will initially be admitted to hospital on 5 volunteers who will receive the investigational drug in the 1 dose The total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) x 10*10 VP/dose). If the safety of the drug is confirmed by the results of observation on the 7th day of the study, the study will continue with the participation of 7 more volunteers in this dosing group.

Further, according to a similar scheme (each time after an interim safety assessment on day 7), the study will include volunteers receiving the drug at a dose of 0.5 ml (Total amount of recombinant pseudo-adenoviral particles (1.0 ± 0.5) x 1011 VP/dose), particles/dose and 0.5 ml, -The total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) × 1011 VP/dose .

Conditions: Influenza A Virus Infection, Influenza A, Influenza Epidemic, Influenza H5N1
Being tested: GamFluVac
Keywords: influenza, vaccine, vector vaccine
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GamFluVacBiological
1 dose (0,5 ml)

Study groups in NCT03651544
Study group	Role	What they receive
Group 1 (GamFluVac dose1)	Experimental	The total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) x 1010 VP/dose. Receives: Biological: GamFluVac
Group 2 (GamFluVac dose2)	Experimental	Total amount of recombinant pseudo-adenoviral particles (1.0 ± 0.5) x 1011 VP/dose Receives: Biological: GamFluVac
Group 3 (GamFluVac dose3)	Experimental	The total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) × 1011 VP/dose Receives: Biological: GamFluVac

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 28 days

Secondary outcomes (2)

Assessment of antigen-specific cell-mediated immune response
determination of specific T-cell- mediated response vs. baseline values
Measured: at days 0 and 7
Antibody levels a measured by an enzyme-linked immunosorbent assay (ELISA)
Determination of antibody levels measured by an ELISA vs. baseline values
Measured: at days 0 and 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 201814 Mar 2019

First posted29 Aug 2018
Study start15 Oct 2018
Primary completion24 Dec 2018
Study completion14 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Influenza A Virus InfectionStudies 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: Non-randomised
Intervention model: Sequential
Model description: Taking into account the fact that the drug is being studied for the first time with the participation of people, initially 5 volunteers will be hospitalized, who will receive the study drug at a dose of 1. If the safety of the drug is confirmed by the results of observation on the 7th day of the study, the study will continue with the participation of 7 more volunteers in this dosing group. Further, according to a similar scheme (each time after an interim safety assessment on day 7), volunteers receiving the drug at a dose 2 and dose 3 will be included in the study.
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03651544
Sponsor's protocol ID: 03-GamFluVac-2018
Status last verified: Jul 2018
First submitted: 24 Aug 2018
Last updated: 15 Mar 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
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Healthy Participants

All Influenza A Virus Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Study of the Safety, Reactogenicity and Immunogenicity of the GamFluVac Vector Vaccine Against Influenza A in Healthy Volunteers in 3 Groups With a Dose Escalation
ClinicalTrials.gov ID: NCT03651544
Acronym / sponsor ID: 03-GamFluVac-2018
Conditions: Influenza A Virus Infection, Influenza A, Influenza Epidemic, Influenza H5N1
Keywords: influenza, vaccine, vector vaccine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
Study start: 15 Oct 2018 (actual)
Primary completion: 24 Dec 2018 (actual)
Study completion: 14 Mar 2019 (actual)
First posted: 29 Aug 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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3
Model description: Taking into account the fact that the drug is being studied for the first time with the participation of people, initially 5 volunteers will be hospitalized, who will receive the study drug at a dose of 1. If the safety of the drug is confirmed by the results of observation on the 7th day of the study, the study will continue with the participation of 7 more volunteers in this dosing group. Further, according to a similar scheme (each time after an interim safety assessment on day 7), volunteers receiving the drug at a dose 2 and dose 3 will be included in the study.

Arm	Type	Receives
Group 1 (GamFluVac dose1)	Experimental	Biological: GamFluVacThe total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) x 1010 VP/dose.
Group 2 (GamFluVac dose2)	Experimental	Biological: GamFluVacTotal amount of recombinant pseudo-adenoviral particles (1.0 ± 0.5) x 1011 VP/dose
Group 3 (GamFluVac dose3)	Experimental	Biological: GamFluVacThe total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) × 1011 VP/dose

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
GamFluVac1 dose (0,5 ml)	Biological	Group 1 (GamFluVac dose1), Group 2 (GamFluVac dose2), Group 3 (GamFluVac dose3)

Primary outcome

Number of Participants With Adverse Events
Time frame: Through the whole study, an average of 28 days
Determination of Number of Participants With Adverse Events

2 secondary outcomes

Assessment of antigen-specific cell-mediated immune response
Time frame: at days 0 and 7
Antibody levels a measured by an enzyme-linked immunosorbent assay (ELISA)
Time frame: at days 0 and 28

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 15 Mar 2019.
Individual participant dataSharing planned: Undecided

Related trials for Influenza A Virus Infection

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)
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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.

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?

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 15 Mar 2019. 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. 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 Participants With Adverse Events (time frame: Through the whole study, an average of 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03651544.

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 15 Mar 2019.