Reactogenicity, Safety and Immunogenicity of an Universal Influenza Vaccine Uniflu

Phase 1

• Conditions: Safety Issues
• Interventions: Biological: LD Universal Influenza Vaccine Uniflu; Biological: Placebo; Biological: HD Universal Influenza Vaccine Uniflu

• Registration Number: NCT03789539
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-06-02
• Status Verified: 2018-12
• Primary Completion: 2018-12-02
• Study First Submitted: 2018-12-24
• Study First Submitted QC: 2018-12-25
• Last Update Submitted: 2018-12-25
• Study First Posted: 2018-12-28
• Last Update Posted: 2018-12-28
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LD Universal Influenza Vaccine Uniflu	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
Placebo	Placebo	saline 0.5 ml
HD Universal Influenza Vaccine Uniflu	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

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events in treatment vs control group	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

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

Trial Locations

Locations (1)

Research Institute of Influenza; 🇷🇺 Sankt-Petersburg, Saint-Petersburg, Russian Federation