Reactogenicity, Safety and Immunogenicity of an Universal Influenza Vaccine Uniflu

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.

Study Overview

• Status: Unknown
• Conditions: Safety Issues
• Intervention / Treatment: Biological: LD Universal Influenza Vaccine Uniflu; Biological: HD Universal Influenza Vaccine Uniflu; Biological: Placebo

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 1

Contacts and Locations

Study Locations

• Russian Federation
  • Saint-Petersburg
    • Sankt-Petersburg, Saint-Petersburg, Russian Federation, 197376
      • Research Institute of Influenza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events in treatment vs control group	Estimation the quantity of adverse events in treatment group vs control group	42 days (from first visit to termination visit for each subject)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: VA Pharma Limited Liability Company
• Investigators: Study Director: Julia M Savateeva, PhD, VA Pharma Limited Liability Company

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2018
• Primary Completion (Actual): December 2, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: December 24, 2018
• First Submitted That Met QC Criteria: December 25, 2018
• First Posted (Actual): December 28, 2018

Study Record Updates

• Last Update Posted (Actual): December 28, 2018
• Last Update Submitted That Met QC Criteria: December 25, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Safety; Reactogenicity; Universal Influenza Vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: UIV-I-01/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No