Reactogenicity, Safety and Immunogenicity of a TB/FLU-01L Tuberculosis Vaccine
|ClinicalTrials.gov Identifier: NCT03017378|
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : January 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis||Biological: TB/FLU-01L||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
TB/FLU-01L (sublingual application)
- 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.
- 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).
- 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
- 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.
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
|National Center for Tuberculosis Problems, Kazakhstan|
|Almaty Qalasy, Almaty, Kazakhstan, 050000|
|Principal Investigator:||Berik M Khairullin, PhD||Research Institute for Biological Safety Problems|