Clinical trial NCT03017378: Reactogenicity, Safety and Immunogenicity of a TB/FLU-01L Tuberculosis Vaccine
Official title: A Randomized, Open Clinical Trial Phase 1 Vaccine TB/FLU-01L by Intranasal and Sublingual Application for Specific Immunotherapy Pulmonary Tuberculosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tuberculosis
Keywords: influenza vector
tuberculosis
vaccine
Lead sponsor: Research Institute for Biological Safety Problems
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, Kazakhstan
name: Research Institute of Influenza, Russia
First posted: 2017-01-11
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Adverse Events (AE) - Immediate reactions
timeFrame: Two hours
measure: Solicited local and systemic reactions
timeFrame: Greater than 2 hours after administration of any dose of vaccine through 7 days following any dose
measure: Unsolicited AEs
timeFrame: Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days following any dose
measure: Serious adverse events (SAEs), including abnormal laboratory findings
timeFrame: Three weeks of receipt of any dose
Secondary outcomes:
Other outcomes:
Locations:
city: Almaty Qalasy
country: Kazakhstan
facility: National Center for Tuberculosis Problems, Kazakhstan
state: Almaty
Study officials:
affiliation: Research Institute for Biological Safety Problems
name: Berik M Khairullin, PhD
role: PRINCIPAL_INVESTIGATOR
References: