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Reactogenicity, Safety and Immunogenicity of an Universal Influenza Vaccine Uniflu

Primary Purpose

Safety Issues

Status
Unknown status
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
LD Universal Influenza Vaccine Uniflu
HD Universal Influenza Vaccine Uniflu
Placebo
Sponsored by
VA Pharma Limited Liability Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Safety Issues focused on measuring Safety, Reactogenicity, Universal Influenza Vaccine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Research Institute of Influenza

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

LD Universal Influenza Vaccine Uniflu

HD Universal Influenza Vaccine Uniflu

Placebo

Arm Description

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

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

saline 0.5 ml

Outcomes

Primary Outcome Measures

Number of participants with adverse events in treatment vs control group
Estimation the quantity of adverse events in treatment group vs control group

Secondary Outcome Measures

Assessment of Immunogenicity
Determination of antibody levels of IgG to M2e protein measured by IFA vs. baseline values

Full Information

First Posted
December 24, 2018
Last Updated
December 25, 2018
Sponsor
VA Pharma Limited Liability Company
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1. Study Identification

Unique Protocol Identification Number
NCT03789539
Brief Title
Reactogenicity, Safety and Immunogenicity of an Universal Influenza Vaccine Uniflu
Official Title
Reactogenicity, Safety and Immunogenicity of an Recombinant Universal Influenza Vaccine Uniflu in Healthy Volunteers From 18 to 60 Years Old
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2, 2018 (Actual)
Primary Completion Date
December 2, 2018 (Actual)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Pharma Limited Liability Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Safety Issues
Keywords
Safety, Reactogenicity, Universal Influenza Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LD Universal Influenza Vaccine Uniflu
Arm Type
Active Comparator
Arm Description
low dose of Uniflu vaccine 0.5 ml (20 mkg of recombinant protein HBc-4M2eh) administrated intramuscularly 2 times at 21 days intervals
Arm Title
HD Universal Influenza Vaccine Uniflu
Arm Type
Active Comparator
Arm Description
high dose of Uniflu vaccine 0.5 ml (40 mkg of recombinant protein HBc-4M2eh) administrated intramuscularly 2 times at 21 days intervals
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
saline 0.5 ml
Intervention Type
Biological
Intervention Name(s)
LD Universal Influenza Vaccine Uniflu
Intervention Description
low dose Universal Influenza Vaccine Uniflu
Intervention Type
Biological
Intervention Name(s)
HD Universal Influenza Vaccine Uniflu
Intervention Description
High dose Universal Influenza Vaccine Uniflu
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo saline
Primary Outcome Measure Information:
Title
Number of participants with adverse events in treatment vs control group
Description
Estimation the quantity of adverse events in treatment group vs control group
Time Frame
42 days (from first visit to termination visit for each subject)
Secondary Outcome Measure Information:
Title
Assessment of Immunogenicity
Description
Determination of antibody levels of IgG to M2e protein measured by IFA vs. baseline values
Time Frame
Time Frame: at days 1, 21, 42.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion criteria 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. Hepatitis B and C. Tuberculosis. Regular past or current use of narcotic drugs. Pregnancy or breastfeeding. Any conditions which may influence the evaluation of the results of the study, in the anamnesis and also according to the screening examination data.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia M Savateeva, PhD
Organizational Affiliation
VA Pharma Limited Liability Company
Official's Role
Study Director
Facility Information:
Facility Name
Research Institute of Influenza
City
Sankt-Petersburg
State/Province
Saint-Petersburg
ZIP/Postal Code
197376
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Reactogenicity, Safety and Immunogenicity of an Universal Influenza Vaccine Uniflu

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