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Reactogenicity, Safety and Immunogenicity of an Universal Influenza Vaccine Uniflu

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03789539
Recruitment Status : Active, not recruiting
First Posted : December 28, 2018
Last Update Posted : December 28, 2018
Sponsor:
Information provided by (Responsible Party):
VA Pharma Limited Liability Company

Brief 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.


Condition or disease Intervention/treatment Phase
Safety Issues Biological: LD Universal Influenza Vaccine Uniflu Biological: HD Universal Influenza Vaccine Uniflu Biological: Placebo Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reactogenicity, Safety and Immunogenicity of an Recombinant Universal Influenza Vaccine Uniflu in Healthy Volunteers From 18 to 60 Years Old
Actual Study Start Date : June 2, 2018
Actual Primary Completion Date : December 2, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Active Comparator: LD Universal Influenza Vaccine Uniflu
low dose of Uniflu vaccine 0.5 ml (20 mkg of recombinant protein HBc-4M2eh) administrated intramuscularly 2 times at 21 days intervals
Biological: LD Universal Influenza Vaccine Uniflu
low dose Universal Influenza Vaccine Uniflu

Active Comparator: HD Universal Influenza Vaccine Uniflu
high dose of Uniflu vaccine 0.5 ml (40 mkg of recombinant protein HBc-4M2eh) administrated intramuscularly 2 times at 21 days intervals
Biological: HD Universal Influenza Vaccine Uniflu
High dose Universal Influenza Vaccine Uniflu

Placebo Comparator: Placebo
saline 0.5 ml
Biological: Placebo
Placebo saline




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Assessment of Immunogenicity [ Time Frame: Time Frame: at days 1, 21, 42. ]
    Determination of antibody levels of IgG to M2e protein measured by IFA vs. baseline values



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Men and women aged 18 to 60 years old.
  2. Healthy that verificated by vital signs, physical examination, blood and urine lab tests
  3. Body mass index (BMI) from 18.5 to 30.5 weight >50 kg
  4. Written informed consent.
  5. Consent to the use of effective contraceptive methods throughout the study period.
  6. Negative pregnancy test (for fertile women), consent to the use of effective contraceptive methods throughout the study period.

Exclusion criteria

  1. Participation of a volunteer in any other study in the last 90 days; any vaccination in the last 30 days;
  2. Vaccination within 6 months before the start of the study (including during participation in other clinical trials).
  3. Symptoms of respiratory illness in the last 3 days.
  4. Symptoms of any acute in the screening period.
  5. Administration of immunoglobulins or other blood products for the last 3 months.
  6. Taking immunosuppressive drugs and / or immunomodulators within 6 months before the start of the study.
  7. Hypersensitivity or allergic reactions to the administration of any vaccine in medical history.
  8. The presence of anaphylactic reactions, angioedema or other SAE to the administration of any vaccine in medical history.
  9. Allergic reactions to vaccine components.
  10. Seasonal allergy (at autumn period).
  11. 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
  12. Leukemia or any other blood disease or malignancy of other organs.
  13. Thrombocytopenic purpura or bleeding disorders in medical history.
  14. Seizures in medical history.
  15. The presence or suspected presence of various immunosuppressive or immunodeficient state, including HIV infection.
  16. Hepatitis B and C.
  17. Tuberculosis.
  18. Regular past or current use of narcotic drugs.
  19. Pregnancy or breastfeeding.
  20. Any conditions which may influence the evaluation of the results of the study, in the anamnesis and also according to the screening examination data.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789539


Locations
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Russian Federation
Research Institute of Influenza
Sankt-Petersburg, Saint-Petersburg, Russian Federation, 197376
Sponsors and Collaborators
VA Pharma Limited Liability Company
Investigators
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Study Director: Julia M Savateeva, PhD VA Pharma Limited Liability Company

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Responsible Party: VA Pharma Limited Liability Company
ClinicalTrials.gov Identifier: NCT03789539     History of Changes
Other Study ID Numbers: UIV-I-01/2017
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by VA Pharma Limited Liability Company:
Safety
Reactogenicity
Universal Influenza Vaccine
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs