E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy subjects actively working with or in the vicinity of replicating Vaccinia virus will receive immunization IMVAMUNE to offer protection against accidential Vaccinia virus infection. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10041197 |
E.1.2 | Term | Smallpox |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066048 |
E.1.2 | Term | Vaccinia |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To provide potential provision of immunogenicity against infection with Vaccinia Virus by prophylactic, voluntary IMVAMUNE® vaccination for persons who work with or must be in the vicinity of replicating Vaccinia virus and therefore are at-risk for contracting vaccinia infection during work, for instance, laboratory workers and vaccine-production workers.
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E.2.2 | Secondary objectives of the trial |
Safety and reactogenicity of IMVAMUNE® vaccination in this study population.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Healthy male and female subjects who will work with or in the vicinity of replicating Vaccinia virus and are at-risk for contracting vaccinia infection during work and who volunteer for the program. 2. Health status will be assessed by medical history, physical examination and clinical laboratory tests. 3. Age: 18 to 60 (inclusive) years 4. Women of child-bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to each vaccination. 5. Women of child-bearing potential must agree to use an acceptable method of contraception during the vaccination period, and must continue to use it for at least 28 days after the last vaccination. 6. Read, signed and dated informed consent form (ICF) after being advised of the risks and benefits of the trial in a language understood by the subject prior to performance of any trial specific procedure.
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E.4 | Principal exclusion criteria |
1. Pregnant or breast-feeding women. 2. History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject. 3. Present uncontrolled serious infection i.e., not responding to antimicrobial therapy. 4. History of or active autoimmune disease. 5. Known or by the clinical investigator suspected relevant impairment of immunologic function including, but not limited to, clinically significant liver disease; uncontrolled diabetes mellitus; moderate to severe kidney impairment or post organ transplant subjects which might interfere with the safety and/or immunogenicity of IMVAMUNE® vaccination. 6. History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure. 7. History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other clinical relevant heart condition to the discretion of the investigator. 8. History of allergies or reactions to eggs, egg products, or gentamycin. 9. History of any anaphylactic shock or severe allergic reaction requiring immediate treatment. 10. Having received any vaccinations or planned vaccinations with a live vaccine within 28 days or a killed vaccine within 14 days prior to or after IMVAMUNE® vaccination. 11. Chronic administration (defined as more than 6 days) of systemic corticosteroids within 90 days of the first planned vaccination. 12. Use of any investigational or non-registered drug or vaccine within 30 days preceding the first IMVAMUNE® vaccine dose, or planned administration of such a drug during the trial period.
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E.5 End points |
E.5.1 | Primary end point(s) |
Determination of immune response measured by a Vaccinia-specific Enzyme-linked immunosorbent assay (ELISA). Percentage of subjects with an ELISA response, i.e. either an appearance of antibody titers above the assay cut-off value for initially seronegative subjects, or an increase of the antibody titer compared to the baseline titer for subjects with a pre-existing antibody titer, at all individual blood sampling time-points.
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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 | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 |
prophylactic immunization against vaccinia virus |
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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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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 | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
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 | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 18 |
E.8.9.2 | In all countries concerned by the trial days | 0 |