Study to Assess Safety, Tolerability and Reactogenicity of Vaccine "UniFluVec" After Two Intranasal Administrations in Healthy Volunteers

NCT04650971 | Completed Phase 1 DMC

• 1 other identifier: UFV-I-01/2017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety, tolerability, reactogenicity and immunogenic activity of the universal influenza vector vaccine "UniFluVec" at two dose levels after two intranasal administrations in healthy adults. The volunteers randomized to the study group received intranasally 0.5 ml of the vaccine (0.25 ml in each nostril) as nasal aerosol stray twice with an interval of 3 weeks. The vaccine of the first dose level contained 6.7 log EID50/0.5 ml (50% egg infective dose) of attenuated recombinant influenza A/H1N1pdm09 virus; vaccine of the second dose level contained 7.7 log EID50/0.5 ml of attenuated recombinant influenza A/H1N1pdm09 virus. The primary objective of the study was to evaluate the safety, tolerability and reactogenicity profile of vaccine "UniFluVec" based on the frequency and severity of adverse events. The secondary objective of the study was to assess the immunogenicity.

Conditions

Influenza A

Keywords

Healthy volunteers; Vector vaccine; UniFluVec

Outcome Measures

Primary Outcomes (1)

• Number of Adverse events

  Adverse events (AEs) were summarized per treatment arm according to the current Medical Dictionary for Regulatory Activities (medDRA) version 21.1. For each preferred term, frequency counts and percentages were calculated. Related and unrelated AEs were assessed. Special attention was paid to vaccine-specific significant AEs: * Immediate AEs occurring within two hours after administration of the vaccine and detected both by the medical personnel and based on the information provided by the volunteer to the research staff. * Post-vaccination reactions (foreseen local and systemic clinical signs), usually caused by intranasal vaccination within two hours and the subsequent 7 days after administration of the vaccine.

  Day -7 (7 days before first dose) - Day 111

Secondary Outcomes (7)

• Assessment of the virus reisolation after the vaccination

  Day 2 - Day 5, Day 23, Day 25

• The content of serum antibodies

  Day 1, Day 21, Day 42

• The content of serum neutralizing antibodies

  Day 1, Day 21, Day 42

• The content of serum Immunoglobulins class G (IgG)

  Day 1, Day 21, Day 42

• The content of serum Immunoglobulins class E (IgE)

  Day 1, Day 21, Day 42

Other Outcomes (1)

• The content of cytokines

  Day 1, Day 2, Day 3

Study Arms (3)

Vaccine "UniFluVec" 6.7 log EID50/dose

EXPERIMENTAL

Cohort 1 - 30 subjects were randomized in a 2:1 ratio to be treated either with Vaccine "UniFluVec" 6.7 log EID50/dose (20 subjects) or with placebo (10 subject, see placebo arm).

Biological: UniFluVec

Vaccine "UniFluVec" 7.7 log EID50/dose

EXPERIMENTAL

Cohort 2 - 30 subjects were randomized in a 2:1 ratio to be treated either with Vaccine "UniFluVec" 7.7 log EID50/dose (20 subjects) or with placebo (10 subject, see placebo arm).

Biological: UniFluVec

Placebo

PLACEBO COMPARATOR

Placebo comparator arm consists of 20 subjects (10 subject in each Сohort).

Biological: Placebo

Interventions

UniFluVec BIOLOGICAL

Vaccination was performed intranasally (0.25 ml in each nostril) twice with an interval of 3 weeks

Vaccine "UniFluVec" 6.7 log EID50/dose; Vaccine "UniFluVec" 7.7 log EID50/dose

Placebo BIOLOGICAL

Vaccination was performed intranasally (0.25 ml in each nostril) twice with an interval of 3 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Availability of signed informed consent.
• Adult men and women at the age from 18 through 49 years old.
• Diagnosis "healthy", verified by standard examination.
• Body weight ≥ 50 kg.
• The subjects, who are antibody-negative to influenza A/H1N1pdm virus (antibody titers ≤1:10 based on Hemagglutination inhibition assay (HIA)).
• Ability and voluntary desire to keep records in the Self-Observation Diary, as well as to attend all the visits of the study for the medical control.
• Consent of study subjects to use reliable contraception methods during the entire period of their participation in the study, as well as within 3 months after completion of participation in the study.

You may not qualify if:

• Participation in another clinical study within three months prior to the beginning of this study; plans to participate in another study during the period of this study.
• Frequent nosebleeds within the year before the study in the past medical history (\> 5).
• Clinically significant anatomical pathology of the paranasal area or signs of surgical intervention in the area of the nose, sinus sinuses or traumatic injuries of the nose during the month before the beginning of screening.
• Symptoms of acute respiratory disease, including fever, or other acute diseases as of the screening date or within two weeks before the beginning of screening.
• Treatment with immunoglobulins or other blood products within three months prior to the beginning of screening or planning such treatment during participation in this study; blood/plasma donation (from 450 ml blood or plasma) in less than 2 months prior to screening.
• Participation in any previous studies to assess vaccines containing influenza viruses A/H1N1pdm09.
• Severe allergic reactions, including asthma, Quincke's edema, anaphylactic shock in the past medical history.
• Wheezing after a previous immunization with live influenza vaccine in the past medical history.
• Hypersensitivity after any previous vaccination against influenza and/or adverse effects caused by immunization, like body temperature above 40°C, fainting, non-febrile convulsions, anaphylaxis, when there is a minimal risk of association with the previous administration of any vaccine (not only against influenza).
• Suspected hypersensitivity to any components of the investigated vaccine, including chicken egg protein.
• Seasonal (spring or autumn) hypersensitivity to the natural factor effects.
• Acute or chronic clinically significant lesions in the lungs, the cardiovascular system, liver, endocrine, neurological and psychiatric diseases or renal dysfunction, as revealed based on the past medical history, physical examination or clinical laboratory findings, which may have an impact on the study results.
• Leukemia or any other malignant blood diseases or solid malignant neoplasms of other organs in the past medical history.
• Thrombocytopenic purpura blood-clotting disorders in the past medical history.
• Seizures in the past medical history.

Sponsors & Collaborators

• Pharmenterprises Biotech LLC: lead

Study Sites (1)

Federal State Budgetary Institution "Research Institute of Influenza" of the Ministry of Health of the Russian Federation

Saint Petersburg, Russia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: For blinding purposes the Placebo was made with the corresponding labelling of the study drug.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The dose cohorts were included into the study based on evaluation of the safety results performed by the Data Safety Monitoring Committee. 2 doses of vaccine/placebo were used in the study. The volunteers randomized to the study group received intranasally 0.5 ml of the vaccine/placebo (0.25 ml in each nostril) as nasal aerosol stray twice with an interval of 3 weeks.

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 3, 2020
• Study Start: August 29, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: December 3, 2020

Record last verified: 2020-11

Locations

RU (1)