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Reactogenicity, Safety and Immunogenicity Study of a Allantoic Split Inactivated Seasonal Influenza Vaccine (VSI)

Primary Purpose

Influenza, Human

Status
Completed
Phase
Phase 1
Locations
Kazakhstan
Study Type
Interventional
Intervention
influenza vaccine
Placebo
Sponsored by
Research Institute for Biological Safety Problems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza, Human focused on measuring vaccine, 1 phase, safety

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteers of both sexes aged 18-60 years.
  • Persons seronegative against A/H1N1 influenza virus, A/H3N2 and type B (with antibody titers ≤1: 10, according to hemagglutination-inhibition (HI) assay to determine).
  • Literate and willing to provide written informed consent.
  • A signed informed consent.

Exclusion Criteria:

  • Available in anamnaze volunteer at any allergic reactions.
  • Allergic reactions to chicken proteins, or any preceding vaccination.
  • Acute illness with a fever (37.0 C).
  • Vaccination against influenza in the 2012/2013 season.
  • Seropositive volunteers against A/H1N1 influenza virus, A/H3N2 and type B (with antibody titers greater than 1:10 according HI).
  • Current or recent (within two weeks of enrollment) acute respiratory illness with or without fever.
  • Hypersensitivity after previous administration of any vaccine.
  • History of chronic alcohol abuse and/or illegal drug use.
  • Any clinically significant abnormal laboratory finding.
  • A positive pregnancy test for all women of childbearing potential.
  • Administration of immunosuppressive drugs or other immune modifying drugs within 4 weeks prior to study enrollment.
  • Acute or chronic clinically significant pulmonary disease, cardiovascular disease, gastrointestinal disease, liver disease, neurological illness, liver disease, blood disease, skin disorder, endocrine disorder, neurological illness and psychiatric disorder as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives.
  • History of leukemia or any other blood or solid organ cancer.
  • Seropositive for HIV, hepatitis B surface antigen and/or hepatitis C antibodies.
  • Receipt of antivirals, antibiotics, immunoglobulins or other blood products within 4 weeks prior to study enrollment or planned receipt of such products during the period of subject participation in the study.
  • Participation in another clinical trial within the previous three months or planned enrollment in such a trial during the period of this study.
  • Subjects who are, in the opinion of the investigator, at significantly increased risk of non-cooperation with requirements of the study protocol.

Sites / Locations

  • Kazakh National Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Allantoic split inactivated seasonal influenza vaccine

Placebo

Arm Description

Allantoic split inactivated seasonal influenza vaccine

Water for Injection

Outcomes

Primary Outcome Measures

Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
Participants recorded solicited injection site and systemic adverse events in a Subject Diary. Solicited Locals AEs were: Injection Site Pain, Injection Site Redness, Injection Site Swelling, Injection Site Induration and Injection Site Ecchymosis. Solicited Systemic AEs were: Pyrexia, Malaise, Chills, Fatigue, Headache, Sweaty, Myalgia, Arthralgia, Nausea and Vomiting.
Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
The percentage of participants with any abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout the study reported as AEs.
Serious adverse events (SAEs), including abnormal laboratory findings
Serious adverse events (SAEs) are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Secondary Outcome Measures

Geometric Mean Fold Increase in HI Antibody Titer
Geometric mean fold increase in HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared with Baseline.
Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer
Seroconversion rate was measured by hemagglutination inhibition (HI) antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from the Baseline HI antibody titer in participants with a Baseline titer ≥10, or achieving an HI antibody titer of ≥40 in participants with a Baseline titer <10.
Seroprotection Rate of HI Antibody Titer
Seroprotection rate, defined as the percentage of participants with HI antibody titer of ≥40, was measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference.

Full Information

First Posted
January 4, 2017
Last Updated
January 20, 2017
Sponsor
Research Institute for Biological Safety Problems
Collaborators
Asfendiyarov Kazakh National Medical University, Research Institute of Influenza, Russia
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1. Study Identification

Unique Protocol Identification Number
NCT03028116
Brief Title
Reactogenicity, Safety and Immunogenicity Study of a Allantoic Split Inactivated Seasonal Influenza Vaccine
Acronym
VSI
Official Title
A Randomized, Blinded, Placebo-controlled Study of Phase I Allantoic Split Inactivated Seasonal Influenza Vaccine in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Research Institute for Biological Safety Problems
Collaborators
Asfendiyarov Kazakh National Medical University, Research Institute of Influenza, Russia

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
The study is a single centre, phase I, double-blind, randomized, placebo-controlled trial that explored the safety and immunogenicity of single dose a allantoic split inactivated seasonal influenza vaccine in healthy adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human
Keywords
vaccine, 1 phase, safety

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Allantoic split inactivated seasonal influenza vaccine
Arm Type
Active Comparator
Arm Description
Allantoic split inactivated seasonal influenza vaccine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Water for Injection
Intervention Type
Biological
Intervention Name(s)
influenza vaccine
Intervention Description
A allantoic split inactivated seasonal influenza vaccine has been prepared on eggs and is made from inactivated parts of the following influenza virus strains: NIBRG-121xp (A/California/7/2009 (H1N1)v and А/PR/8/34 (H1N1)), NYMC X-217 (A/Victoria/361/2011(H3N2) and А/PR/8/34 (H1N1)), NYMC BX-49 (B/Texas/06/2011 (Yamagata lineage) - like High Yield Reassortant (1:1:6) With B/Lee/40 NP, B/Panama/45/90 NS genes).
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
water for injection
Primary Outcome Measure Information:
Title
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
Description
Participants recorded solicited injection site and systemic adverse events in a Subject Diary. Solicited Locals AEs were: Injection Site Pain, Injection Site Redness, Injection Site Swelling, Injection Site Induration and Injection Site Ecchymosis. Solicited Systemic AEs were: Pyrexia, Malaise, Chills, Fatigue, Headache, Sweaty, Myalgia, Arthralgia, Nausea and Vomiting.
Time Frame
Two hours
Title
Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
Description
Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Time Frame
Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days following any dose
Title
Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
Description
The percentage of participants with any abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout the study reported as AEs.
Time Frame
Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days
Title
Serious adverse events (SAEs), including abnormal laboratory findings
Description
Serious adverse events (SAEs) are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame
Three weeks of receipt
Secondary Outcome Measure Information:
Title
Geometric Mean Fold Increase in HI Antibody Titer
Description
Geometric mean fold increase in HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared with Baseline.
Time Frame
Change from Baseline HI Antibody Titer at 21 days
Title
Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer
Description
Seroconversion rate was measured by hemagglutination inhibition (HI) antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from the Baseline HI antibody titer in participants with a Baseline titer ≥10, or achieving an HI antibody titer of ≥40 in participants with a Baseline titer <10.
Time Frame
Change from Baseline HI Antibody Titer at 21 days
Title
Seroprotection Rate of HI Antibody Titer
Description
Seroprotection rate, defined as the percentage of participants with HI antibody titer of ≥40, was measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference.
Time Frame
Change from Baseline HI Antibody Titer at 21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers of both sexes aged 18-60 years. Persons seronegative against A/H1N1 influenza virus, A/H3N2 and type B (with antibody titers ≤1: 10, according to hemagglutination-inhibition (HI) assay to determine). Literate and willing to provide written informed consent. A signed informed consent. Exclusion Criteria: Available in anamnaze volunteer at any allergic reactions. Allergic reactions to chicken proteins, or any preceding vaccination. Acute illness with a fever (37.0 C). Vaccination against influenza in the 2012/2013 season. Seropositive volunteers against A/H1N1 influenza virus, A/H3N2 and type B (with antibody titers greater than 1:10 according HI). Current or recent (within two weeks of enrollment) acute respiratory illness with or without fever. Hypersensitivity after previous administration of any vaccine. History of chronic alcohol abuse and/or illegal drug use. Any clinically significant abnormal laboratory finding. A positive pregnancy test for all women of childbearing potential. Administration of immunosuppressive drugs or other immune modifying drugs within 4 weeks prior to study enrollment. Acute or chronic clinically significant pulmonary disease, cardiovascular disease, gastrointestinal disease, liver disease, neurological illness, liver disease, blood disease, skin disorder, endocrine disorder, neurological illness and psychiatric disorder as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives. History of leukemia or any other blood or solid organ cancer. Seropositive for HIV, hepatitis B surface antigen and/or hepatitis C antibodies. Receipt of antivirals, antibiotics, immunoglobulins or other blood products within 4 weeks prior to study enrollment or planned receipt of such products during the period of subject participation in the study. Participation in another clinical trial within the previous three months or planned enrollment in such a trial during the period of this study. Subjects who are, in the opinion of the investigator, at significantly increased risk of non-cooperation with requirements of the study protocol.
Facility Information:
Facility Name
Kazakh National Medical University
City
Almaty
ZIP/Postal Code
050000
Country
Kazakhstan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Reactogenicity, Safety and Immunogenicity Study of a Allantoic Split Inactivated Seasonal Influenza Vaccine

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