Safety of RUTI® Vaccination in MDR-TB Patients

Phase 2

Terminated

• Conditions: Tuberculosis, Multidrug Resistant
• Interventions: Biological: Matching RUTI® Placebo; Biological: RUTI® Therapeutic vaccine

• Registration Number: NCT02711735
• Lead Sponsor: Archivel Farma S.L.

Brief Summary

Prospective, randomized, double-blind, multicentre, placebo-controlled clinical phase IIa trial to evaluate safety and immunogenicity of RUTI® vaccine in Multidrug-resistant Tuberculosis (MDR-TB) patients favourably responding to standard MDR-TB treatment. Time point of vaccination starts at 16 weeks upon start of standard MDR-TB treatment (cohort A), and if clinically safe as evaluated by an independent panel of experts (DSMB), another cohort of patients will be vaccinated at 2 weeks upon start of standard MDR-TB treatment (cohort B), All the patients will be followed up 8 weeks after vaccination.

Detailed Description

Prospective, randomized, double-blind, multicentre, placebo-controlled clinical phase IIa trial to evaluate safety and immunogenicity of RUTI® vaccine in Multidrug-resistant Tuberculosis (MDR-TB) patients favourably responding to standard MDR-TB treatment. Time point of vaccination starts at 16 weeks upon start of standard MDR-TB treatment (cohort A), and if clinically safe as evaluated by an independent panel of experts (DSMB), another cohort of patients will be vaccinated at 2 weeks upon start of standard MDR-TB treatment (cohort B)

Study Timeline

• Study First Submitted: 2016-02-25
• Study First Submitted QC: 2016-03-16
• Study First Posted: 2016-03-17
• Study Start: 2020-03-18
• Primary Completion: 2020-09-09
• Study Completion: 2020-09-09
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Matching RUTI® Placebo	Matching RUTI® Placebo	Intervention: Patients randomized to receive Placebo will receive one injection of Placebo in their right or left deltoid muscle.
RUTI® vaccine	RUTI® Therapeutic vaccine	Intervention: Patients randomized to receive RUTI® vaccine will receive one injection of RUTI® vaccine in their right or left deltoid muscle.

Primary Outcome Measures

Name	Time	Method
Clinical safety parameters related to vaccination	8 weeks	Safety Evaluation: Physical examination, SAEs, routine laboratory, chest radiography, between the intervention and control group within 8 weeks after vaccination.

Secondary Outcome Measures

Name	Time	Method
IFN-y release of PBMCs in response to antigen stimulation	8 weeks	Immunogenicity Evaluation: Immunogenic properties of RUTI® vaccine (before vaccination and at week 2 and 8 after vaccination) compared to placebo assessed by i) IFN-γ production of ex vivo stimulated peripheral blood mononuclear cells (PBMC)
Mycobacterial Growth Inhibition Assay	8 weeks	Immunogenicity Evaluation: Immunogenic properties of RUTI® vaccine (before vaccination and at week 2 and 8 after vaccination) compared to placebo assessed by the summative ability of PBMCs to control mycobacterial growth in an ex vivo system.

Trial Locations

Locations (3)

"Chernivtsi Regional Clinical TB Dispensary", II tuberculosis department of multidrug-resistant tuberculosis; 🇺🇦 Chernivtsi, Ukraine

"Ivano-Frankivsk Regional Phthisiopulmonology Center of Ivano-Frankivsk Regional Council", Center for Pulmonary Diseases; 🇺🇦 Ivano-Frankivs'k, Ukraine

Medical Department #2 (resistant tuberculosis) of Kharkiv Regional Antituberculosis Dispensary No1; 🇺🇦 Kharkiv, Ukraine