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

NCT03028116 | Completed Phase 1 DMC

• 1 other identifier: VSI-I-01/2016
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza, Human

Keywords

vaccine; 1 phase; safety

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Geometric Mean Fold Increase in HI Antibody Titer

  Change from Baseline HI Antibody Titer at 21 days

• Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer

  Change from Baseline HI Antibody Titer at 21 days

• Seroprotection Rate of HI Antibody Titer

  Change from Baseline HI Antibody Titer at 21 days

Study Arms (2)

Allantoic split inactivated seasonal influenza vaccine

ACTIVE COMPARATOR

Allantoic split inactivated seasonal influenza vaccine

Biological: influenza vaccine

Placebo

PLACEBO COMPARATOR

Water for Injection

Biological: Placebo

Interventions

influenza vaccine BIOLOGICAL

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).

Allantoic split inactivated seasonal influenza vaccine

Placebo BIOLOGICAL

water for injection

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Institute for Biological Safety Problems: lead
• Asfendiyarov Kazakh National Medical University: collaborator
• Research Institute of Influenza, Russia: collaborator

Study Sites (1)

Kazakh National Medical University

Almaty, Almaty, 050000, Kazakhstan

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

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: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 23, 2017
• Study Start: May 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: January 23, 2017

Record last verified: 2016-12

Locations

KA (1)