Reactogenicity, Safety and Immunogenicity of an Universal Influenza Vaccine Uniflu

VA Pharma Limited

Status and phase: Unknown; Phase 1

Conditions: Safety Issues

Treatments: Biological: LD Universal Influenza Vaccine Uniflu; Biological: HD Universal Influenza Vaccine Uniflu; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03789539

UIV-I-01/2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 3 patient groups, including a placebo group

LD Universal Influenza Vaccine Uniflu

Active Comparator group

Description:

low dose of Uniflu vaccine 0.5 ml (20 mkg of recombinant protein HBc-4M2eh) administrated intramuscularly 2 times at 21 days intervals

Treatment:

Biological: LD Universal Influenza Vaccine Uniflu

HD Universal Influenza Vaccine Uniflu

Active Comparator group

Description:

high dose of Uniflu vaccine 0.5 ml (40 mkg of recombinant protein HBc-4M2eh) administrated intramuscularly 2 times at 21 days intervals

Treatment:

Biological: HD Universal Influenza Vaccine Uniflu

Placebo

Placebo Comparator group

Description:

saline 0.5 ml

Treatment:

Biological: Placebo