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

NCT03016143 | Completed Phase 2 DMC

• 1 other identifier: VSI-II-01/2016
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a single centre, phase II, double-blind, randomized, comparative trial that explored the immunogenicity and safety of single dose a allantoic split inactivated seasonal influenza vaccine and VAXIGRIP vacccine in healthy adults the two age groups (in persons 18 to 60 years of age and older than 60 years).

Conditions

Influenza

Keywords

phase II; split; vaccine

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (4)

• Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)

  21 Days

• Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)

  21 Days

• Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs

  21 Days

• Serious adverse events (SAEs), including abnormal laboratory findings

  21 Days

Study Arms (4)

Group #1 (Allantoic Split Inactivated Seasonal flu Vaccine)

ACTIVE COMPARATOR

100 volunteers aged 18 to 60 years, which introduced the vaccine allantoic split inactivated seasonal influenza

Biological: Allantoic Split Inactivated Seasonal flu Vaccine

Group #2 (Allantoic Split Inactivated Seasonal flu Vaccine)

ACTIVE COMPARATOR

100 volunteers over the age of 60 years, which introduced the vaccine allantoic split inactivated seasonal influenza

Biological: Allantoic Split Inactivated Seasonal flu Vaccine

Group #3 (Vaccine VAXIGRIP)

EXPERIMENTAL

50 volunteers aged 18 to 60 years, which introduced vaccine VAXIGRIP

Biological: VAXIGRIP

Group #4 (Vaccine VAXIGRIP)

EXPERIMENTAL

50 volunteers over the age of 60 years, which introduced vaccine VAXIGRIP

Biological: VAXIGRIP

Interventions

Allantoic Split Inactivated Seasonal flu Vaccine BIOLOGICAL

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).

Group #1 (Allantoic Split Inactivated Seasonal flu Vaccine); Group #2 (Allantoic Split Inactivated Seasonal flu Vaccine)

VAXIGRIP BIOLOGICAL

Vaxigrip - Seasonal Influenza, split virion, inactivated vaccine. Sanofi Pasteur Serial Number N3E681V

Group #3 (Vaccine VAXIGRIP); Group #4 (Vaccine VAXIGRIP)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• volunteers (men and women) aged 18 years and older.
• 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 2015/2016 season.
• 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.
• 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.

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, 050000, Kazakhstan

Location

Related Publications (1)

• Sarsenbayeva G, Issagulov T, Kassenov M, Abitay R, Orynbayev M, Stukova M, Pisareva M, Davlyatshin T, Lespek K, Khairullin B. Safety and immunogenicity of trivalent inactivated influenza vaccine in adults 60 years of age and older: a phase II, a randomized, comparative trial in Kazakhstan. Hum Vaccin Immunother. 2020 Aug 2;16(8):1791-1797. doi: 10.1080/21645515.2019.1705691. Epub 2020 Feb 12.

  PMID: 32048890 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

vaxigrip

Condition Hierarchy (Ancestors)

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

Study Officials

• Berik M Khairullin, PhD

  Research Institute for Biological Safety Problems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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 10, 2017
• Study Start: October 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 7, 2018

Record last verified: 2017-01

Locations

KA (1)