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

NCT02501421 | Completed Phase 1 DMC

• 1 other identifier: VPT-I-01/2013
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tuberculosis

Keywords

vaccine; influenza vector; tuberculosis

Outcome Measures

Primary Outcomes (4)

• Immediate reactions

  Immediate reactions occurring within two hours of administration of any dose

  Two hours

• Solicited local and systemic reactions

  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

  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

  All SAEs during three weeks after receipt of any dose

  Three weeks of receipt of any dose

Study Arms (2)

TB/FLU-04L

ACTIVE COMPARATOR

Live recombinant influenza vectored tuberculosis vaccine

Biological: tuberculosis vaccine

Placebo

PLACEBO COMPARATOR

Buffer

Biological: Placebo

Interventions

tuberculosis vaccine BIOLOGICAL

Live recombinant influenza vectored tuberculosis vaccine

Also known as: TB/FLU-04L

TB/FLU-04L

Placebo BIOLOGICAL

Buffer

Placebo

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

MeSH Terms

Conditions

Tuberculosis

Interventions

Tuberculosis Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2015
• First Posted: July 17, 2015
• Study Start: October 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: February 1, 2015
• Last Updated: August 28, 2020

Record last verified: 2015-07