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Reactogenicity, Safety and Immunogenicity of a TB/FLU-04L Tuberculosis Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02501421
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : July 20, 2015
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, double-blind, randomized, placebo-controlled trial that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21) TB/FLU-04L tuberculosis vaccine versus matched placebo in BCG-vaccinated healthy adult subjects aged 18-50 years.

Condition or disease Intervention/treatment Phase
Tuberculosis Biological: tuberculosis vaccine Biological: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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-04L
Live recombinant influenza vectored tuberculosis vaccine
Biological: tuberculosis vaccine
Live recombinant influenza vectored tuberculosis vaccine
Other Name: TB/FLU-04L

Placebo Comparator: Placebo
Biological: Placebo

Primary Outcome Measures :
  1. Immediate reactions [ Time Frame: Two hours ]
    Immediate reactions occurring within two hours of administration of any dose

  2. Solicited local and systemic reactions [ Time Frame: Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days following any dose ]
    Adverse events commonly associated with intranasal vaccination

  3. Unsolicited events and abnormal laboratory findings [ Time Frame: Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days following any dose ]
    Adverse events not associated with intranasal vaccination and abnormal laboratory findings

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

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

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.

Responsible Party: Research Institute for Biological Safety Problems Identifier: NCT02501421     History of Changes
Other Study ID Numbers: VPT-I-01/2013
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: July 20, 2015
Last Verified: July 2015

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

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