Reactogenicity, Safety and Immunogenicity of a TB/FLU-01L Tuberculosis Vaccine

NCT ID: NCT03017378

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-02-28

Brief Summary

The study is a single centre, phase I, open, randomized, by intranasal and sublingual application trial that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21) TB/FLU-01L tuberculosis vaccine in BCG-vaccinated healthy adult subjects aged 18-50 years.

Conditions

Tuberculosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TB/FLU-01L (intranasal application)

Vaccine safety analysis of TB/FLU-01L at double intranasal application in healthy volunteers aged 18 to 50 years.

Group Type: ACTIVE_COMPARATOR

TB/FLU-01L

Intervention Type: BIOLOGICAL

TB / FLU-01L (intranasal application)

TB/FLU-01L (sublingual application)

Vaccine safety analysis of TB/FLU-01L at double sublingual application in healthy volunteers aged 18 to 50 years.

Group Type: ACTIVE_COMPARATOR

TB/FLU-01L

Intervention Type: BIOLOGICAL

TB/FLU-01L (sublingual application)

Interventions

TB/FLU-01L

TB / FLU-01L (intranasal application)

Intervention Type: BIOLOGICAL

TB/FLU-01L

TB/FLU-01L (sublingual application)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Healthy BCG-vaccinated male or female adult 18 through 50 years of age at the enrollment visit.
• Literate and willing to provide written informed consent.
• A signed informed consent.
• Capable and willing to complete diary cards and willing to return for all follow-up visits.
• For females, willing to take reliable birth control measures throughout the entire period of participation in the study

Exclusion Criteria

• Clinical, radiological (chest X-ray) or laboratory evidence of active or past TB disease.
• Current or past administration of anti-TB therapy.
• History of contact with TB patients.
• Positive QuantiFERON-TB Gold test.
• BCG vaccination in less than 6 months prior to study.
• Practice of nasal irrigation on a regular basis within the past six months or has engaged in nasal irrigation within two weeks prior to enrollment.
• Recent history of frequent nose bleeds (>5 within the past year).
• Clinically relevant abnormal paranasal anatomy.
• Recent history (within the past month) of rhino or sinus surgery, or surgery for any traumatic injury of the nose.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Health, Kazakhstan

OTHER_GOV

Sponsor Role: collaborator

Research Institute of Influenza, Russia

OTHER

Sponsor Role: collaborator

Research Institute for Biological Safety Problems

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Berik M Khairullin, PhD

Role: PRINCIPAL_INVESTIGATOR

Research Institute for Biological Safety Problems

Locations

National Center for Tuberculosis Problems, Kazakhstan

Almaty Qalasy, Almaty, Kazakhstan

Countries

Kazakhstan

Other Identifiers

VIT-I-01/2013

Identifier Type: -

Identifier Source: org_study_id