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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT Number: 2006-000690-29 |
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| Name | Class |
|---|---|
| Archivel Farma S.L. | INDUSTRY |
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The aim of this study is to evaluate the safety of a new vaccine against Tuberculosis (RUTI) when administered to healthy adult volunteers, compared to placebo; and determine its safe dosage range. An initial evaluation of immune responses to the vaccine compared to placebo will also be undertaken.
In the present Phase I clinical trial, four increasing doses of RUTI will be tested, the groups composed by 6 volunteers each. (Total of 24 volunteers). The escalation to a new dose to test will be done after the safety of the previous dose has been ensured.
For each dose of FCMtb to test, each volunteer will be inoculated twice (at day 0 and day 28) with RUTI (4 volunteers) or placebo (2 volunteers) and will be followed-up up to 25 weeks from the first inoculation. The global length of the study will be approximately 15 months.
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. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RUTI 5 micrograms of FCMtb | Experimental | RUTI dose: 5 micrograms of FCMtb (for fragmented cells of M. tuberculosis) (n=4) |
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| RUTI 25 micrograms of FCMtb | Experimental | RUTI dose: 25 micrograms of FCMtb (for fragmented cells of M. tuberculosis) (n=4) |
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| RUTI 100 micrograms of FCMtb | Experimental | RUTI dose: 100 micrograms of FCMtb (for fragmented cells of M. tuberculosis) (n=4) |
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| RUTI 200 micrograms of FCMtb | Experimental | RUTI 200 micrograms of FCMtb (for fragmented cells of M. tuberculosis) (n=4) |
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| placebo | Placebo Comparator | placebo of the vaccine RUTI (total n=8, n=2 for each period) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RUTI | Biological | dose: 5 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28 |
|
| Measure | Description | Time Frame |
|---|---|---|
| VAS Pain Score (Visual Analogic Scale, That Ranges From 0 to 100) to Evaluate Each Volunteer Subjective Pain Intensity at the Inoculation Point | at protocol defined timepoints: days 0, 1, 3, 7, 21, 28, 29, 31, 35, 56 | |
| Occurrence, Intensity and Relationship to Vaccination of Local and Systemic Events | during the whole study | |
| Number of Clinically Relevant Abnormalities in the Laboratory Tests According to the Doctors' Impression | haematological and biochemical laboratory tests | at protocol defined timepoints: days 0, 7, 21, 28, 35, 56, 112 & 156 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the Immunogenicity of the Different Doses of the Vaccine Tested | Immunological assays are performed at all timepoints to determine vaccine immunogenicity | at protocol defined timepoints: days 0, 7, 21, 28, 35, 56, 112 & 156 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pere-Joan Cardona, MD, PhD | Unitat de Tuberculosi Experimental. Fundació Institut per la Investigació en Ciències de la Salut Germans Trias i Pujol. | Principal Investigator |
| Joan Costa, MD, PhD | Pharmacology Department. Hospital Universitari "Germans Trias i Pujol" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Experimental Tuberculosis Unit. Fundació Institut per la Investigació Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15661388 | Background | Cardona PJ, Amat I, Gordillo S, Arcos V, Guirado E, Diaz J, Vilaplana C, Tapia G, Ausina V. Immunotherapy with fragmented Mycobacterium tuberculosis cells increases the effectiveness of chemotherapy against a chronical infection in a murine model of tuberculosis. Vaccine. 2005 Feb 3;23(11):1393-8. doi: 10.1016/j.vaccine.2004.09.008. | |
| 16426520 |
| Label | URL |
|---|---|
| Fundació Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol homepage | View source |
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24 volunteers were enrolled and distributed in 4 groups, one group for every period (each period: 6 new volunteers). There was one period per dose tested, and doses were tested increasingly, not beginning to test one dose until clinically ensured the safety of the previous dose. The double blind was opened at the end of the study.
Four RUTI doses were tested, in a sequencial way (n=6 each). 14 days before starting each level of treatment, subjects, after signing the informed consent, were screened in the Phase 1 Unit (Hospital Germans Trias i Pujol) in order to decide if they were elegible to be part of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | RUTI 5 Micrograms of FCMtb | RUTI dose: 5 micrograms of FCMtb |
| FG001 | RUTI 25 Micrograms of FCMtb | RUTI dose: 25 micrograms of FCMtb |
| FG002 | RUTI 100 Micrograms of FCMtb | RUTI dose: 100 micrograms of FCMtb |
| FG003 | RUTI 200 Micrograms of FCMtb | RUTI dose: 200 micrograms of FCMtb |
| FG004 | Placebo | placebo of the vaccine RUTI, given subcutaneously twice, on days 0 and 28 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| I |
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| ID | Title | Description |
|---|---|---|
| BG000 | RUTI 5 Micrograms of FCMtb | RUTI dose: 5 micrograms of FCMtb |
| BG001 | RUTI 25 Micrograms of FCMtb | RUTI dose: 25 micrograms of FCMtb |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | VAS Pain Score (Visual Analogic Scale, That Ranges From 0 to 100) to Evaluate Each Volunteer Subjective Pain Intensity at the Inoculation Point | Not Posted | Nov 2008 | Mean | Standard Deviation | units on a scale | at protocol defined timepoints: days 0, 1, 3, 7, 21, 28, 29, 31, 35, 56 | |||||||||
| Secondary | Evaluation of the Immunogenicity of the Different Doses of the Vaccine Tested | Immunological assays are performed at all timepoints to determine vaccine immunogenicity | Not Posted | Nov 2008 | Number | Standard Deviation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cristina Vilaplana, MD | UTE. Fund. Inst. Germans Trias i Pujol | +34 93 497 86 81 | cvilaplana@gmail.com |
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| ID | Term |
|---|---|
| D055985 | Latent Tuberculosis |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| RUTI | Biological | dose: 25 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28 |
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| RUTI | Biological | dose: 100 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28 |
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| RUTI | Biological | dose: 200 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28 |
|
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| placebo of the vaccine RUTI | Biological | placebo of the vaccine RUTI given subcutaneously twice, on days 0 and 28 |
|
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| Hospital Germans Trias i Pujol |
| Badalona |
| Barcelona |
| 08916 |
| Spain |
| Pharmacology Department. Hospital Universitari Germans Trias i Pujol. | Badalona | Barcelona | 08916 | Spain |
| Cardona PJ, Amat I. [Origin and development of RUTI, a new therapeutic vaccine against Mycobacterium tuberculosis infection]. Arch Bronconeumol. 2006 Jan;42(1):25-32. doi: 10.1016/s1579-2129(06)60110-9. Spanish. |
| 16545981 | Background | Cardona PJ. RUTI: a new chance to shorten the treatment of latent tuberculosis infection. Tuberculosis (Edinb). 2006 May-Jul;86(3-4):273-89. doi: 10.1016/j.tube.2006.01.024. Epub 2006 Mar 20. |
| 18397200 | Background | Vilaplana C, Ruiz-Manzano J, Gil O, Cuchillo F, Montane E, Singh M, Spallek R, Ausina V, Cardona PJ. The tuberculin skin test increases the responses measured by T cell interferon-gamma release assays. Scand J Immunol. 2008 Jun;67(6):610-7. doi: 10.1111/j.1365-3083.2008.02103.x. Epub 2008 Apr 4. |
| 18524883 | Background | Guirado E, Gil O, Caceres N, Singh M, Vilaplana C, Cardona PJ. Induction of a specific strong polyantigenic cellular immune response after short-term chemotherapy controls bacillary reactivation in murine and guinea pig experimental models of tuberculosis. Clin Vaccine Immunol. 2008 Aug;15(8):1229-37. doi: 10.1128/CVI.00094-08. Epub 2008 Jun 4. |
| 18827194 | Background | Gil O, Vilaplana C, Guirado E, Diaz J, Caceres N, Singh M, Cardona PJ. Enhanced gamma interferon responses of mouse spleen cells following immunotherapy for tuberculosis relapse. Clin Vaccine Immunol. 2008 Nov;15(11):1742-4. doi: 10.1128/CVI.00255-08. Epub 2008 Sep 30. |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG002 | RUTI 100 Micrograms of FCMtb | RUTI dose: 100 micrograms of FCMtb |
| BG003 | RUTI 200 Micrograms of FCMtb | RUTI dose: 200 micrograms of FCMtb |
| BG004 | Placebo | placebo of the vaccine RUTI, given subcutaneously twice, on days 0 and 28 |
| BG005 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| at protocol defined timepoints: days 0, 7, 21, 28, 35, 56, 112 & 156 |
| Primary | Occurrence, Intensity and Relationship to Vaccination of Local and Systemic Events | Not Posted | Nov 2008 | Number | ocurrences/subjects (O/S) | during the whole study |
| Primary | Number of Clinically Relevant Abnormalities in the Laboratory Tests According to the Doctors' Impression | haematological and biochemical laboratory tests | All the participants of the study were analyzed for this specific outcome measure. | Posted | Oct 2008 | Number | number of abnormalities | at protocol defined timepoints: days 0, 7, 21, 28, 35, 56, 112 & 156 |
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The disclosure of the results has to be previously arranged if mutually agreeable to both investigators and the company manufacturer of the vaccine RUTI: Archivel Farma S.L.
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000085343 | Latent Infection |