Clinical trial NCT03028116: Reactogenicity, Safety and Immunogenicity Study of a Allantoic Split Inactivated Seasonal Influenza Vaccine
Official title: A Randomized, Blinded, Placebo-controlled Study of Phase I Allantoic Split Inactivated Seasonal Influenza Vaccine in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza, Human
Keywords: vaccine
1 phase
safety
Lead sponsor: Research Institute for Biological Safety Problems
Sponsor class: OTHER_GOV
Collaborators: name: Asfendiyarov Kazakh National Medical University
name: Research Institute of Influenza, Russia
First posted: 2017-01-23
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
timeFrame: Two hours
measure: Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
timeFrame: Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days following any dose
measure: Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
timeFrame: Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days
measure: Serious adverse events (SAEs), including abnormal laboratory findings
timeFrame: Three weeks of receipt
Secondary outcomes:
measure: Geometric Mean Fold Increase in HI Antibody Titer
timeFrame: Change from Baseline HI Antibody Titer at 21 days
measure: Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer
timeFrame: Change from Baseline HI Antibody Titer at 21 days
measure: Seroprotection Rate of HI Antibody Titer
timeFrame: Change from Baseline HI Antibody Titer at 21 days
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Kazakh National Medical University
Study officials:
References: