NCT02711735

Safety of RUTI® Vaccination in MDR-TB Patients

Terminated Phase 2 Last updated 5 July 2022

What this trial tests

Phase 2 trial testing RUTI® Therapeutic vaccine in Tuberculosis, Multidrug Resistant in 9 participants. Terminated before completion.

Timeline

18 March 2020

Primary endpoint
9 September 2020

9 September 2020

Quick facts

Lead sponsor	Archivel Farma S.L.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	9
Start date	18 March 2020
Primary completion	9 September 2020
Estimated completion	9 September 2020
Sites	3 locations across Ukraine

Drugs / interventions tested

• RUTI® Therapeutic vaccine — full drug profile →
• Matching RUTI® Placebo — full drug profile →

Conditions studied

• Tuberculosis, Multidrug Resistant — all drugs for Tuberculosis, Multidrug Resistant →

Sponsor

Archivel Farma S.L. — full company profile →

Who can join

18 and older, any sex, with Tuberculosis, Multidrug Resistant. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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), All the patients will be followed up 8 weeks after vaccination.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. 100 years of Mycobacterium bovis bacille Calmette-Guérin.
   Lange C, Aaby P, Behr MA, Donald PR, et al · · 2022 · cited 165× · PMID 34506734 · DOI 10.1016/s1473-3099(21)00403-5
2. The current status, challenges, and future developments of new tuberculosis vaccines.
   Gong W, Liang Y, Wu X. · · 2018 · cited 84× · PMID 29601253 · DOI 10.1080/21645515.2018.1458806
3. Tuberculosis Vaccine Development: Progress in Clinical Evaluation.
   Sable SB, Posey JE, Scriba TJ. · · 2019 · cited 79× · PMID 31666281 · DOI 10.1128/cmr.00100-19
4. Clinical Development of New TB Vaccines: Recent Advances and Next Steps.
   Hatherill M, White RG, Hawn TR. · · 2019 · cited 55× · PMID 32082273 · DOI 10.3389/fmicb.2019.03154
5. <i>Mycobacterium tuberculosis</i>: immune response, biomarkers, and therapeutic intervention.
   Zhuang L, Yang L, Li L, Ye Z, et al · · 2024 · cited 50× · PMID 38188605 · DOI 10.1002/mco2.419
6. Therapeutic Vaccines for Tuberculosis: An Overview.
   Bouzeyen R, Javid B. · · 2022 · cited 47× · PMID 35812462 · DOI 10.3389/fimmu.2022.878471
7. The impact of human vaccines on bacterial antimicrobial resistance. A review.
   Jansen KU, Gruber WC, Simon R, Wassil J, et al · · 2021 · cited 39× · PMID 34602924 · DOI 10.1007/s10311-021-01274-z
8. Tuberculosis vaccine development: from classic to clinical candidates.
   Li J, Zhao A, Tang J, Wang G, et al · · 2020 · cited 34× · PMID 32060754 · DOI 10.1007/s10096-020-03843-6