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

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ClinicalTrials.gov Identifier: NCT03017378
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : January 11, 2017
Sponsor:
Collaborators:
Ministry of Health, Kazakhstan
Research Institute of Influenza, Russia
Information provided by (Responsible Party):
Research Institute for Biological Safety Problems

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.

Condition or disease Intervention/treatment Phase
Tuberculosis Biological: TB/FLU-01L Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Clinical Trial Phase 1 Vaccine TB/FLU-01L by Intranasal and Sublingual Application for Specific Immunotherapy Pulmonary Tuberculosis
Study Start Date : October 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Tuberculosis

Arm Intervention/treatment
Active Comparator: TB/FLU-01L (intranasal application)
Vaccine safety analysis of TB/FLU-01L at double intranasal application in healthy volunteers aged 18 to 50 years.
Biological: TB/FLU-01L
TB / FLU-01L (intranasal application)

Active Comparator: TB/FLU-01L (sublingual application)
Vaccine safety analysis of TB/FLU-01L at double sublingual application in healthy volunteers aged 18 to 50 years.
Biological: TB/FLU-01L
TB/FLU-01L (sublingual application)




Primary Outcome Measures :
  1. Adverse Events (AE) - Immediate reactions [ Time Frame: Two hours ]
    Commonly Solicited Local reactions associated with injections: pain, erythema/redness, swelling, induration, bruising at the injection site.

  2. Solicited local and systemic reactions [ Time Frame: Greater than 2 hours after administration of any dose of vaccine through 7 days following any dose ]
    Commonly Solicited general symptoms: fever (oral temperature ≥ 38.0°C), chills, muscle aches/myalgia, arthralgia, fatigue, malaise, headache, rash, sweating, nausea, vomiting, diarrhea and potential indicators of oculo-respiratory syndrome* (ORS).

  3. Unsolicited AEs [ Time Frame: Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days following any dose ]
    Unsolicited AEs are any untoward medical occurrence in the subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product

  4. Serious adverse events (SAEs), including abnormal laboratory findings [ Time Frame: Three weeks of receipt of any dose ]
    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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017378


Locations
Kazakhstan
National Center for Tuberculosis Problems, Kazakhstan
Almaty Qalasy, Almaty, Kazakhstan, 050000
Sponsors and Collaborators
Research Institute for Biological Safety Problems
Ministry of Health, Kazakhstan
Research Institute of Influenza, Russia
Investigators
Principal Investigator: Berik M Khairullin, PhD Research Institute for Biological Safety Problems

Responsible Party: Research Institute for Biological Safety Problems
ClinicalTrials.gov Identifier: NCT03017378     History of Changes
Other Study ID Numbers: VIT-I-01/2013
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Research Institute for Biological Safety Problems:
influenza vector
tuberculosis
vaccine

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs