- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02501421
Reactogenicity, Safety and Immunogenicity of a TB/FLU-04L Tuberculosis Vaccine
August 27, 2020 updated by: Research Institute for Biological Safety Problems
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 1
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
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: TB/FLU-04L
Live recombinant influenza vectored tuberculosis vaccine
|
Live recombinant influenza vectored tuberculosis vaccine
Other Names:
|
Placebo Comparator: Placebo
Buffer
|
Buffer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immediate reactions
Time Frame: Two hours
|
Immediate reactions occurring within two hours of administration of any dose
|
Two hours
|
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
|
Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days following any dose
|
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
|
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
|
All SAEs during three weeks after receipt of any dose
|
Three weeks of receipt of any dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
October 1, 2013
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
July 14, 2015
First Submitted That Met QC Criteria
July 15, 2015
First Posted (Estimate)
July 17, 2015
Study Record Updates
Last Update Posted (Actual)
August 28, 2020
Last Update Submitted That Met QC Criteria
August 27, 2020
Last Verified
July 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VPT-I-01/2013
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.
Clinical Trials on Tuberculosis
-
Global Alliance for TB Drug DevelopmentCompletedTuberculosis | Tuberculosis, Pulmonary | Pulmonary Disease | Multi Drug Resistant Tuberculosis | Drug Sensitive Tuberculosis | Drug-resistant Tuberculosis | Mycobacterium Tuberculosis InfectionUnited States
-
Global Alliance for TB Drug DevelopmentCompletedTuberculosis | Tuberculosis, Pulmonary | Pulmonary Disease | Multi Drug Resistant Tuberculosis | Drug Sensitive Tuberculosis | Drug-resistant Tuberculosis | Mycobacterium Tuberculosis InfectionUnited States
-
University of Cape TownUniversity of Stellenbosch; University of Cape Town Lung Institute; University... and other collaboratorsCompletedTuberculosis | Multidrug Resistant Tuberculosis | Extensively-drug Resistant TuberculosisSouth Africa
-
Universiteit AntwerpenAurum Institute; University of Stellenbosch; University of the Free State; Free...RecruitingDrug-resistant Tuberculosis | Rifampicin Resistant Tuberculosis | Pulmonary Tuberculoses | Multidrug Resistant TuberculosisSouth Africa
-
Assistance Publique - Hôpitaux de ParisCompletedExtrapulmonary Tuberculosis | Lymph Node Tuberculosis | Bone TuberculosisFrance
-
Centers for Disease Control and PreventionBoston University; Pfizer; Columbia University; University of Texas; University of... and other collaboratorsCompletedMulti-Drug Resistant Tuberculosis | Extensively Drug Resistant TuberculosisSouth Africa
-
University Medical Center GroningenCompletedMultidrug-resistant Tuberculosis | Extensively Drug-resistant TuberculosisNetherlands
-
Foundation for Innovative New Diagnostics, SwitzerlandInstitute of Tropical Medicine, Belgium; Research Center Borstel; National Institute...CompletedMultidrug-Resistant Tuberculosis | Isoniazid Resistant Pulmonary Tuberculosis | Rifampicin Resistant Tuberculosis | Pulmonary Tuberculoses
-
National Institute of Allergy and Infectious Diseases...CompletedPulmonary Tuberculosis | Multidrug Resistant Tuberculosis | Extensively Drug Resistant TuberculosisKorea, Republic of
-
Wits Health Consortium (Pty) LtdUniversity of Cape Town; Perinatal HIV Research Unit of the University of the... and other collaboratorsActive, not recruitingTuberculosis | Multi Drug Resistant Tuberculosis | Rifampicin Resistant Tuberculosis | Extensively Drug-Resistant Tuberculosis | Pre-XDR-TBSouth Africa
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States