E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10014071 |
E.1.2 | Term | Ebola disease |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 |
Main Study - To assess the safety and reactogenicity of a heterologous 2-dose regimen utilizing Ad26.ZEBOV (first vaccination; Dose 1) and MVA-BN-Filo (second vaccination; Dose 2) administered IM on Days 1 and 57, respectively.
Extension Phase - To provide the heterologous 2-dose vaccination regimen (Ad26.ZEBOV on Day 1 and MVA-BN-Filo on Day 57) to participants in the control arm of the main study. |
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E.2.2 | Secondary objectives of the trial |
To assess binding antibody responses as measured by ELISA at 21 days post-dose-2. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Main Study - 1 - 5: 1. Parent(s) (preferably both if available or as per local requirements)/guardian must sign an ICF indicating that he or she understands the purpose of, and procedures required for the study, and potential risks and benefits of the study, and are willing to allow their child to participate in the study. 2. Parent(s)/guardian are willing/able to ensure that their child adheres to the prohibitions and restrictions specified in this protocol (see Section 4.3). 3. The parent(s)/guardian must be at or above the age of legal consent in the jurisdiction in which the study is taking place. 4. Infant must be aged between 4 and 11 months (ie, 4 months up to <12 months) on the day of randomization. 5. Infant must be healthy in the investigator’s clinical judgment (and the parent(s)/guardian) on the basis of medical history, physical examination, vital signs and clinical laboratory tests performed at screening.
Extension Phase: Prior enrollment in the control arm of the main study and did not withdraw consent, and receipt of at least the first vaccination (Dose 1) in the main study |
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E.4 | Principal exclusion criteria |
Main Study: 1. Having received any candidate or other Ebola vaccine. 2. History of EVD, or prior exposure to Ebola virus, including travel to an area with a current Ebola outbreak less than 1 month prior to screening. 3. Having received any experimental candidate Ad26- or MVA-based vaccine in the past. 4. Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccines [eg, polysorbate 80, ethylenediaminetetraacetic acid (EDTA) or Lhistidine for Ad26.ZEBOV vaccine; tris (hydroxymethyl)-amino methane (THAM) for MVA-BN-Filo vaccine and Neisseria meningitidis polysaccharide or tetanus toxoid for MenACWY]), including known allergy to chicken or egg proteins and aminoglycosides (gentamicin). 5.Presence of acute illness (this does not include minor illnesses such as mild diarrhea or mild upper respiratory tract infection) or axillary temperature ≥37.5ºC on Day 1. Participants with such symptoms will be excluded from enrollment at that time but may be rescheduled for enrollment at a later date.
Extension Phase: Having received any candidate or other Ebola vaccine |
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E.5 End points |
E.5.1 | Primary end point(s) |
Main Study - Solicited local and systemic adverse events until 7 days post-dose-1 and post-dose-2. Main Study - Unsolicited adverse events from the first vaccination until 28 days post-dose-1 and from the second vaccination until 28 days post-dose-2. Main Study - Any serious adverse events until 6 months postdose- 2, and serious adverse events related to study intervention until the end of the study.
Extension Phase - Number of Participants with Completion of the Heterologous 2-dose Vaccination Regimen (Ad26.ZEBOV on Day 1 and MVA-BN-Filo on Day 57). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
-7 days post-dose-1 and post-dose-2. -28 days post-dose-2. -6 months postdose- 2 |
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E.5.2 | Secondary end point(s) |
Main Study - Binding antibody levels against the EBOV GPusing FANG ELISA (EU/mL) at 21 days postdose-2. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
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 |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Conjugate vaccine MenACWY |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
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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The study is considered completed at final database lock, which will occur after the last participant has completed the last study visit or left the study. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 3 |