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

January 10, 2017 updated by: Research Institute for Biological Safety Problems

A Randomized, Open Clinical Trial Phase 1 Vaccine TB/FLU-01L by Intranasal and Sublingual Application for Specific Immunotherapy Pulmonary Tuberculosis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kazakhstan
    • Almaty
      • Almaty Qalasy, Almaty, Kazakhstan, 050000
        • National Center for Tuberculosis Problems, Kazakhstan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
Biological: TB/FLU-01L
TB/FLU-01L (sublingual 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 (intranasal application)
Biological: TB/FLU-01L
TB/FLU-01L (sublingual application)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Two hours
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).
Greater than 2 hours after administration of any dose of vaccine through 7 days following any dose
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
Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days following any dose
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.
Three weeks of receipt of any dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Research Institute for Biological Safety Problems

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Research Institute of Influenza, Russia
Ministry of Health, Kazakhstan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Berik M Khairullin, PhD, Research Institute for Biological Safety Problems

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VIT-I-01/2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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