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

Phase 1

Completed

• Conditions: Influenza, Human
• Interventions: Biological: influenza vaccine; Biological: Placebo

• Registration Number: NCT03028116
• Lead Sponsor: Research Institute for Biological Safety Problems

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Primary Completion: 2016-06
• Study Completion: 2016-07
• Status Verified: 2016-12
• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-01-20
• Last Update Submitted: 2017-01-20
• Study First Posted: 2017-01-23
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allantoic split inactivated seasonal influenza vaccine	influenza vaccine	Allantoic split inactivated seasonal influenza vaccine
Placebo	Placebo	Water for Injection

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs	Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days	The percentage of participants with any abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout the study reported as AEs.
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)	Two hours	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)	Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days following any dose	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.
Serious adverse events (SAEs), including abnormal laboratory findings	Three weeks of receipt	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

Name	Time	Method
Geometric Mean Fold Increase in HI Antibody Titer	Change from Baseline HI Antibody Titer at 21 days	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.
Seroprotection Rate of HI Antibody Titer	Change from Baseline HI Antibody Titer at 21 days	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.
Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer	Change from Baseline HI Antibody Titer at 21 days	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.

Trial Locations

Locations (1)

Kazakh National Medical University; 🇰🇿 Almaty, Kazakhstan