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Tuberculosis, PulmonaryPhase 2CONSTAN-ARGNCT05455112

Safety and Efficacy of RUTI® With the Standard of Treatment for Tuberculosis

A Phase 2 study testing RUTI® Vaccine in people with Tuberculosis, Pulmonary, run by Archivel Farma S.L. at 2 sites in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is proposed to evaluate the safety and efficacy of the RUTI vaccine in patients with pulmonary tuberculosis. Therapeutic vaccination of RUTI would stimulate the immune response not only against growing bacteria, but also against bacteria in a latent state that are less sensitive to antibiotic treatments. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tuberculosis, Pulmonary
What is being tested?
RUTI® Vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
41 participants
Where
2 sitesArgentina
Study dates
29 Oct 2022to 30 Oct 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women aged 18 or older
  • Written informed consent
  • Laboratory confirmed pulmonary TB
  • Clinical symptoms compatible with pulmonary TB and/or X-ray evidence of pulmonary TB
  • Women of non-childbearing potential: at least 2 years post-menopausal or surgically sterile (e.g. tubal ligation)
  • Women of childbearing potential (including women less than 2 years past menopause) must have a negative pregnancy test at enrollment and must agree to use dual-barrier methods of contraception, intrauterine device (IUD), bilateral tubal occlusion, sexual abstinence, or vasectomized partner.
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  • Males must agree to use a double barrier method of contraception at least 1 month after RUTI/placebo vaccination; or the male patient or his female partner must be surgically sterile or the female partner must be post-menopausal
  • Willing and able to attend all study visits and comply with all study procedures
  • Verifiable address or place of residence easy accessible to perform visits and willing to inform the research team of any change during the treatment and follow-up period

Who cannot join

  • Unable to provide written informed consent
  • Women reported, or detected, or willing to be pregnant during the trial period; Men willing to conceive a child during the study or 6 months after end of treatment
  • Severity of illness precluding full evaluation: expected early death, evidenced by respiratory failure, low blood pressure, WHO performance score 3-4
  • Evidence or suspicion of resistance to rifampin, isoniazid, pyrazinamide, and ethambutol, either laboratory-confirmed or based on epidemiological history at screening
  • Previous treatment for M. tuberculosis in the previous 24 months.
  • Bodyweight < 40kg
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  • Unstable Diabetes Mellitus as a poor metabolic control within the past 12 months
  • HIV-infected subjects
  • Major co-morbid conditions or any other finding which in the opinion of the investigator would compromise the protocol compliance or significantly influence the interpretation of results
  • HIstory of severe mental ilness which, in the opinion of the investigator, may exclude the participant from participating in the trial.
  • Any of the following laboratory parameters:
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN)
  • Total bilirubin > 2 x ULN
  • Neutrophil count ≤ 500 neutrophils / mm3
  • Platelet count < 50,000 platelets / mm3
  • Alcohol use: potential participant either self-reports or in the investigator's opinion that the patient drinks more than an average of four units/day over a usual week or is a binge drinker (men: 5 or more drinks; women: consume 4 or more drinks, in about 2 hours)
  • Known allergy or any hipersensitivity to study mediactions, including rifampin, isoniazid, pyrazinamide, and ethambutol, or any of its excipients.
  • Documented allergy to anti-TB vaccines or any excipient of the RUTI vaccine.
  • Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study

Trial locations and contacts

2 sites in 1 country.

Argentina2 sites

  • Hospital José Nestor Lencinas

    Godoy Cruz, Mendoza Province, M5547

  • Hospital de Clínicas Presidente Dr. Nicolás Avellaneda

    San Miguel de Tucumán, Tucumán Province, T4001KKP

Other trials in Argentina

About this study

Official title: Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of the Administration of RUTI® Immunotherapy With the Standard Treatment in Patients With Tuberculosis

This study is proposed to evaluate the safety and efficacy of the RUTI vaccine in patients with pulmonary tuberculosis. Therapeutic vaccination of RUTI would stimulate the immune response not only against growing bacteria, but also against bacteria in a latent state that are less sensitive to antibiotic treatments. Therapeutic vaccination in patients with pulmonary tuberculosis could improve the speed of recovery of patients without inducing the appearance of drug resistance.

Read the detailed description

The safety and immunogenicity of RUTI was established in healthy volunteers, patients with latent tuberculosis (TB); and Drug Susceptible (DS) -TB and Drug resistance (DR)-TB. This study proposed to evaluate the safety and efficacy of the RUTI vaccine in patients with active pulmonary TB. Immunotherapy for TB could shorten the sputum culture conversion, therefore reduce the time required to cure. Therapeutic vaccines do not interfere directly with the causative organism and hence, they are not involved in the development of drug resistance. Therapeutic vaccination would also be beneficial for DS-TB as it could increase the response to the standard therapy and help diminish the development of drug resistance. The vaccination stimulates the immune response during the continuation phase of TB treatment in which the remaining bacteria are poorly sensitive, if not refractory, to antimycobacterial agents, and potentiate chemotherapy. Reducing the huge reservoir of mycobacterium tuberculosis (DS or not) by vaccination strategies could ultimately accelerate elimination of the disease worldwide.

As per the results of the Phase II clinical trial in patients with latent TB, the best polyantigenic response was obtained with a dose of 25µg of RUTI vaccine and the second inoculation did not further increase the response. Based on these findings, a single dose of 25µg of vaccine will be used in the study.

The objective of this study is to i) explore the efficacy as reduction of bacillary load through the study of early bactericidal activity (EBA) in patients with DS-TB; and ii) provide data from safety perspective of the vaccine RUTI (25 µg FCMtb) in patients with TB, when given concomitant with the standard of care treatment initiation.

The study will include patients diagnosed with pulmonary DS-TB, candidate to start treatment with standard-care TB drugs and without any disease that could compromise the assessment of the response to the vaccination, or increase the risk of adverse events. RUTI will be administered on the day of TB treatment start, EBA will be measured on days 2, 4, 7, 10, 12, and 14, and adverse events will be collected up to week 24. Other measurements will be performed to assess the sputum culture conversion (SCC), clinical, X-ray or laboratory worsening, improvement of clinical signs and symptoms, and health-related quality-of-life (HRQOL).

Being tested
RUTI® Vaccine, Placebo
Keywords
Tuberculosis, immunotherapy, drug-susceptible
Medical subject headings
Tuberculosis, Pulmonary, Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RUTI® VaccineBiological

    One subcutaneous injection of RUTI 25µg FCMtb

  • PlaceboBiological

    One subcutaneous injection of saline

Study groups in NCT05455112
Study groupRoleWhat they receive
RUTIExperimentalSingle injection of RUTI 25µg of FCMtb at day 0.
Receives: Biological: RUTI® Vaccine
PlaceboPlacebo comparatorSingle injection of saline at day 0.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Early bactericidal activity (EBA) 0-14

    Change in EBA, using the time to positivity (TTP) of sputum in liquid Mycobacteria Growth Indicator Tube (MGIT)

    Measured: From day 0 to day 14

  2. Adverse events

    Proportion of patients with treatment-emergent adverse events (TEAE)

    Measured: From day 0 to week 24

  3. Grade 3-4 adverse events

    Total number of grade 3 and 4 adverse events (AE)

    Measured: From day 0 to week 24

Secondary outcomes (11)

  1. Time to sputum culture conversion (SCC)

    Time to SCC, in liquid MGIT

    Measured: From day 0 to week 16

  2. Proportion of SCC at week 16

    Proportion of participants with SCC, in liquid MGIT

    Measured: From day 0 to week 16

  3. Proportion of SCC at week 16

    Proportion of participants with SCC, in liquid MGIT

    Measured: From day 0 to week 8

  4. Early bactericidal activity (EBA) 2-14

    Change in EBA, using the TTP of sputum in liquid MGIT

    Measured: From day 2 to day 14

  5. Early bactericidal activity (EBA) 7-14

    Change in EBA, using the TTP of sputum in liquid MGIT

    Measured: From day 7 to day 14

  6. Early bactericidal activity (EBA) 24 weeks

    Change in EBA, using the TTP of sputum in liquid MGIT

    Measured: From day 0 to week 24

  7. Proportion of SCC per weeks

    Proportion of participants with SCC, in liquid MGIT

    Measured: Weeks 4, 12, 16, and 24

  8. Clinical worsening

    Proportion of participants with clinical, X-ray, or laboratory worsening

    Measured: From day 0 to week 24

  9. Improvement of clinical signs and symptoms

    Proportion of participants with improvement on Bandim TB score

    Measured: Weeks 1, 2, 8, 12, 16, and 24.

  10. Improvement of quality of life

    Proportion of participants with improvement on health-related quality of life (HRQOL)

    Measured: Weeks 8 and 24

  11. Discontinuation of TB treatment

    Proportion of participants who discontinue treatment due to failure, resistance, other.

    Measured: From day 0 to week 24.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2022
  2. Study start29 Oct 2022
  3. Primary completion30 Oct 2024
  4. Study completion30 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05455112
Sponsor's protocol ID
CONSTAN-ARG
Acronym
CONSTAN-ARG
Status last verified
Dec 2025
First submitted
8 Jul 2022
Last updated
10 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RUTI® Vaccine in people with Tuberculosis, Pulmonary, run by Archivel Farma S.L. at 2 sites in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Early bactericidal activity (EBA) 0-14 (time frame: From day 0 to day 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05455112.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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