Reactogenicity, Safety and Immunogenicity of an Universal Influenza Vaccine Uniflu

NCT03789539 | Unknown Phase 1 DMC

• 1 other identifier: UIV-I-01/2017
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Safety Issues

Keywords

Safety; Reactogenicity; Universal Influenza Vaccine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment of Immunogenicity

  Time Frame: at days 1, 21, 42.

Study Arms (3)

LD Universal Influenza Vaccine Uniflu

ACTIVE COMPARATOR

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

HD Universal Influenza Vaccine Uniflu

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

saline 0.5 ml

Biological: Placebo

Interventions

LD Universal Influenza Vaccine Uniflu BIOLOGICAL

low dose Universal Influenza Vaccine Uniflu

LD Universal Influenza Vaccine Uniflu

HD Universal Influenza Vaccine Uniflu BIOLOGICAL

High dose Universal Influenza Vaccine Uniflu

HD Universal Influenza Vaccine Uniflu

Placebo BIOLOGICAL

Placebo saline

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Participation of a volunteer in any other study in the last 90 days; any vaccination in the last 30 days;
• Vaccination 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.
• Symptoms of any acute in the screening period.
• 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.
• Hypersensitivity or allergic reactions to the administration of any vaccine in medical history.
• The presence of anaphylactic reactions, angioedema or other SAE to the administration of any vaccine in medical history.
• Allergic reactions to vaccine components.
• Seasonal allergy (at autumn period).
• 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
• Leukemia or any other blood disease or malignancy of other organs.
• Thrombocytopenic purpura or bleeding disorders in medical history.
• Seizures in medical history.
• The presence or suspected presence of various immunosuppressive or immunodeficient state, including HIV infection.

Sponsors & Collaborators

• VA Pharma Limited Liability Company: lead

Study Sites (1)

Research Institute of Influenza

Saint Petersburg, Sankt-Peterburg, 197376, Russia

Location

Study Officials

• Julia M Savateeva, PhD

  VA Pharma Limited Liability Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 24, 2018
• First Posted: December 28, 2018
• Study Start: June 2, 2018
• Primary Completion: December 2, 2018
• Study Completion: December 31, 2018
• Last Updated: December 28, 2018

Record last verified: 2018-12

Locations

RU (1)