MedTrace Logo

Safety of RUTI® Vaccination in MDR-TB Patients

NCT02711735 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2022-07-05

No results posted yet for this study

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.

Conditions

  • Tuberculosis, Multidrug Resistant

Interventions

BIOLOGICAL

RUTI® Therapeutic vaccine

Participants randomised to this arm will receive one single dose of RUTI® vaccine in the right/left deltoid muscle.

BIOLOGICAL

Matching RUTI® Placebo

Participants randomised to this arm will receive aone single dose of matching RUTI® placebo in the right / left deltoid

Sponsors & Collaborators

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • Archivel Farma S.L.

    lead INDUSTRY

Principal Investigators

  • Tjip S van der Werf, MD PhD · University Medical Center Groningen, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-18
Primary Completion
2020-09-09
Completion
2020-09-09

Countries

  • Ukraine

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02711735 on ClinicalTrials.gov