E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
BCG vaccination / immune respons |
BCG vaccinatie / afweerreactie op de vaccinatie |
|
E.1.1.1 | Medical condition in easily understood language |
TB-vaccination |
Tuberculose vaccinatie |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Primary objective is to characterize the anti-mycobacterial immune responses during vaccination with live-attenuated M.Bovis BCG Danish strian 1331, in order to provide a framework for using biomarkers in future TB vaccine trials. |
Het karakteriseren van anti-mycobacteriele immuunresponsen gedurende vaccinatie met levende BCG, hetgeen een raamwerk kan verschaffen om biomarkers te gebruiken voor toekomstige TB vaccin trials. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate wheter biomarkers, specific for BCG can be detected in the circulations and in the urine following vaccination.
|
Biomarkers specifiek voor BCG te decteren in de circulatie en urine na BCG vaccinatie. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy
Age 18-55 year
Naieve tuberculose volunteers (negaitve TST and negative QFN-test) |
Gezond
Leeftijd 18-55 jaar
Negatief voor tuberculose in de TST en QFN-test |
|
E.4 | Principal exclusion criteria |
History of TB disease or treatment
BCG vaccination
HIV-positive
Pregancy breastfeeding |
Voorgeschiedenis met TB-ziekte of handeling
BCG-vaccinatie
HIV positief
Zwangerschap/borstvoeding |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Vaccine induced changes in the antigen-specific immune response and in BCG-specific biomarkers following vaccination with BCG
Changes in biomarkers for T-cells |
Vaccin gerelateerde veranderingen
Veranderingen in biomarkers voor T-cellen |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Vaccine induced changes in the antigen-specific immune response and in BCG-specific biomarkers following vaccination with BCG
Changes in biomarkers for T-cells |
Vaccin gerelateerde veranderingen
Veranderingen in biomarkers voor T-cellen |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last subject, last visit = end of trial |
Laatste vrijwilliger, laatste bezoek = eind studie |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |