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

A Randomized, Blinded, Placebo-controlled Study of Phase I Allantoic Split Inactivated Seasonal Influenza Vaccine in Healthy Adults

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.

Study Overview

• Status: Completed
• Conditions: Influenza, Human
• Intervention / Treatment: Biological: influenza vaccine; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• Kazakhstan
  • Almaty, Kazakhstan, 050000
    • Kazakh National Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Allantoic split inactivated seasonal influenza vaccine	Biological: influenza vaccine; 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).
PLACEBO_COMPARATOR: Placebo; Water for Injection	Biological: Placebo; water for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Two hours
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.	Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days following any dose
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.	Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days
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.	Three weeks of receipt

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from Baseline HI Antibody Titer at 21 days
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.	Change from Baseline HI Antibody Titer at 21 days
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.	Change from Baseline HI Antibody Titer at 21 days

Collaborators and Investigators

• Sponsor: Research Institute for Biological Safety Problems
• Collaborators: Research Institute of Influenza, Russia; Asfendiyarov Kazakh National Medical University

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: January 20, 2017
• First Posted (ESTIMATE): January 23, 2017

Study Record Updates

• Last Update Posted (ESTIMATE): January 23, 2017
• Last Update Submitted That Met QC Criteria: January 20, 2017
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: safety; vaccine; 1 phase
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: VSI-I-01/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No