E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy individuals or HIV-1 infected individuals |
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E.1.1.1 | Medical condition in easily understood language |
Healthy individuals or HIV-1 infected individuals |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 22.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10022891 |
E.1.2 | Term | Investigations |
E.1.2 | System Organ Class | 10022891 - Investigations |
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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 |
Cytotoxicity of Yellow Fever specific CD8 T cells Following YF-17D Vaccination |
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E.2.2 | Secondary objectives of the trial |
- To identify immunodominant epitopes - To investigate effect of HLA-type on immune response - To discover novel yellow fever vaccine epitopes and to define the optimal time-window for CD8+ T cell licensing - To provide proof that in vivo generated virus-specific CD8+ T cells can be licensed to kill target cells ex vivo - Investigate cytotoxicity of virus-specific cells in an adoptive-transfer study in humanized mice
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
At vaccination (every participant) - Age between 18 to 60 years - Ability to give informed consent
At screening (HIV-1 infection) - CD4+ T cell count >350 cells/mm3 - Plasma HIV-1 RNA levels <50 cps/ml for a minimum of 18 months |
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E.4 | Principal exclusion criteria |
At vaccination (every participant) - Fever orally (>37,5 C) - On imunosuppresive therapy - Pregnant or breastfeeding (urine hcg will be performed) - Severe immunodeficiency (not HIV-1 infection) - Thymus dysfunction - Egg allergy - Bleeding disorder - Previous allergic reaction to vaccination
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E.5 End points |
E.5.1 | Primary end point(s) |
Cytotoxicity of virus-specific (NS4B 214LLWNGPMAV222) CD8+ T cells in peripheral blood |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
- 21±3 after vaccination - 100±40 after vaccination |
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E.5.2 | Secondary end point(s) |
- To identify immunodominant epitopes with focus on HLA*A1, *A2, *B7 and *B35 - Licensing generated virus-specific CD8+ T cells to kill target cells ex vivo - Licensing generated virus-specific CD8+ T cells to kill target cellsin in vivo (adoptive transfer study in humanized mice) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- 21±3 after vaccination - 100±40 after vaccination |
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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 | Yes |
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 | Yes |
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 |
Licensing generated virus-specific CD8+ T cells to kill target cell ex vivo and in vivo |
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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 | Yes |
E.8.1.7.1 | Other trial design description |
Sponsor-investigator initiated single-arm vaccine trial |
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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.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
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
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Vaccine trial will have last subject last visit in 4Q2022, while the ex vivo and in vivo experiments will end 4Q023. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |