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

NCT03017378 | Completed Phase 1 DMC

• 1 other identifier: VIT-I-01/2013
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Keywords

influenza vector; tuberculosis; vaccine

Outcome Measures

Primary Outcomes (4)

• Adverse Events (AE) - Immediate reactions

  Commonly Solicited Local reactions associated with injections: pain, erythema/redness, swelling, induration, bruising at the injection site.

  Two hours

• Solicited local and systemic reactions

  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

  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

  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

Study Arms (2)

TB/FLU-01L (intranasal application)

ACTIVE COMPARATOR

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 (sublingual application)

ACTIVE COMPARATOR

Vaccine safety analysis of TB/FLU-01L at double sublingual application in healthy volunteers aged 18 to 50 years.

Biological: TB/FLU-01L

Interventions

TB/FLU-01L BIOLOGICAL

TB / FLU-01L (intranasal application)

TB/FLU-01L (intranasal application)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Institute for Biological Safety Problems: lead
• Ministry of Health, Kazakhstan: collaborator
• Research Institute of Influenza, Russia: collaborator

Study Sites (1)

National Center for Tuberculosis Problems, Kazakhstan

Almaty Qalasy, Almaty, 050000, Kazakhstan

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Berik M Khairullin, PhD

  Research Institute for Biological Safety Problems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 11, 2017
• Study Start: October 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: February 1, 2015
• Last Updated: January 11, 2017

Record last verified: 2017-01

Locations

KA (1)