Clinical Trial to Investigate the Safety, Tolerability, and Immunogenicity of the Novel Antituberculous Vaccine RUTI® Following One Month of Isoniazid Treatment in Subjects With Latent Tuberculosis Infection

Tuberculosis Clinical Trial

Official title:
Double-Blind, Randomized, Placebo-Controlled Phase II Clinical Trial to Investigate the Safety, Tolerability, and Immunogenicity of the Novel Antituberculous Vaccine RUTI® Following One Month of Isoniazid Treatment in Subjects With Latent Tuberculosis Infection

Status Completed

Clinical Trial Summary

The aim of the trial is to assess the safety, tolerability and immunogenicity of two doses of RUTI® vaccine administered four weeks apart after one month pre-treatment with INH.

The trial will be double-blinded, randomized and placebo-controlled with 96 subjects (48 HIV- and 48 HIV+ subjects).

Three different RUTI® doses and placebo will be tested, randomizing assigned both in HIV+ and HIV- subjects. Each subject will be randomized to receive one of the four treatments (placebo, 5, 25, 50 μg), after completion of one month INH pre-treatment (one tablet of 300mg/day, vp.o.). Each subject will receive two administrations of the same treatment, 28 days apart. Subjects will be monitored until one month after the second inoculation with RUTI®.

Clinical Trial Description

RUTI is a therapeutic vaccine made from virulent M.tuberculosis bacteria, grown in stressful conditions, fragmented, detoxified, heat inactivated (FCMtb) and liposomed. RUTI provides a strong humoral and cellular immune response against antigens from active growing and latent bacilli but also against structural antigens, as it has been proved in animal models of latent tuberculosis infection and in phase I clinical trial of Healthy Volunteers. The vaccine has been designed to be used against Latent Tuberculosis Infection as a therapeutic vaccine after 1-month of chemotheraputic treatment, instead the current treatment based on 6-9 months of chemotherapy. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01136161
Study type	Interventional
Source	Archivel Farma S.L.
Contact
Status	Completed
Phase	Phase 2
Start date	June 2010
Completion date	May 2011

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05738681` - Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial	Phase 2/Phase 3
Recruiting	`NCT05526885` - Tuberculosis Diagnostic Trial of CAD4TB Screening Alone Compared to CAD4TB Screening Combined With a CRP Triage Test, Both Followed by Confirmatory Xpert MTB/RIF Ultra in Communities of Lesotho and South Africa	N/A
Completed	`NCT04369326` - Community Initiated Preventive Therapy for TB	N/A
Recruiting	`NCT04568967` - TB-CAPT EXULTANT - HIV	N/A
Completed	`NCT02337270` - Phase 1 Clinical Trial of the Safety and Immunogenicity of an Adenovirus-based TB Vaccine Administered by Aerosol	Phase 1
Not yet recruiting	`NCT06253715` - Shortened Regimen for Drug-susceptible TB in Children	Phase 3
Recruiting	`NCT04271397` - Immunological Biomarkers in Tuberculosis Management	N/A
Withdrawn	`NCT03639038` - Tuberculosis Diagnosis by Flow Cytometry
Completed	`NCT03199313` - Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid	Phase 1
Recruiting	`NCT04975178` - Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa	Phase 3
Completed	`NCT04463680` - Rifampin and the Contraceptive Implant	Phase 4
Completed	`NCT03973970` - Assessing the Ability of the T-SPOT®.TB Test (IQ)
Recruiting	`NCT04230395` - Alcohol Reduction Among People With TB and HIV in India	N/A
Completed	`NCT04874948` - Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment	Phase 1
Active, not recruiting	`NCT02906007` - Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV	Phase 1/Phase 2
Not yet recruiting	`NCT05917210` - Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda	N/A
Not yet recruiting	`NCT05845112` - Start Taking Action For TB Diagnosis
Not yet recruiting	`NCT06017843` - Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding	N/A
Active, not recruiting	`NCT02715271` - Study of TB Lesions Obtained in Therapeutical Surgery
Completed	`NCT02781909` - Potential Efficacy and Safety of Using Adjunctive Ibuprofen for XDR-TB Tuberculosis	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.