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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002171-17 | EudraCT Number |
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The purpose of this trial is to assess the safety and immunogenicity of an investigational RNActive® rabies vaccine (CV7201) in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 80 µg CV7201 mRNA short | Experimental | Vaccination by injection on days 0, 7, 28. |
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| 160µg CV7201 mRNA short | Experimental | Vaccination by injection on days 0, 7, 28. |
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| 80 µg CV7201 mRNA long | Experimental | Vaccination by injection on days 0, 28, 56. |
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| 160 µg CV7201 mRNA long | Experimental | Vaccination by injection on days 0, 28, 56. |
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| 320 µg CV7201 mRNA long | Experimental | Vaccination by injection on days 0, 28, 56. |
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| 640 µg CV7201 mRNA long | Experimental | Vaccination by injection on days 0, 28. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CV7201 mRNA | Biological | CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of serious adverse events (SAEs)/adverse events (AEs) and local tolerability assessment of the vaccination site | The occurrence of AEs will be assessed by non-directive questioning of the subject at each visit. Further, AEs volunteered by the subject during or between visits - as subject diary card entries - or detected through observation, physical examination, laboratory test, or other assessments during the entire observation period, will be documented. Subjects will be instructed that they must immediately report any AEs, subjective complaints or objective changes in their well-being to the Investigator or the clinic personnel, regardless of the perceived relationship between the event and the test product. The Investigator is responsible for reporting all AEs in the eCRF that are observed or described by the subject, regardless of their relationship to the trial vaccine or their clinical significance. | up to 64 days after the last vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| The lowest CV7201 dose to elicit rabies VNTs ≥ 0.5 IE/ml | Rabies virus neutralizing titers (VNTs) measured in serum blood samples taken 14 days after the the last vaccination (Visit 8). | Rabies VNTs measured 14 days after the 3rd vaccination (Visit 8) |
| Number of treatment discontinuation due to IMP-related AEs/SAEs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Franz-Josef Falkner von Sonnenburg, MD | Ludwig-Maximilians - University of Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abteilung für Infektions- und Tropenmedizin der Ludwig-Maximilians-Universität | Munich | 80802 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28754494 | Derived | Alberer M, Gnad-Vogt U, Hong HS, Mehr KT, Backert L, Finak G, Gottardo R, Bica MA, Garofano A, Koch SD, Fotin-Mleczek M, Hoerr I, Clemens R, von Sonnenburg F. Safety and immunogenicity of a mRNA rabies vaccine in healthy adults: an open-label, non-randomised, prospective, first-in-human phase 1 clinical trial. Lancet. 2017 Sep 23;390(10101):1511-1520. doi: 10.1016/S0140-6736(17)31665-3. Epub 2017 Jul 25. |
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| ID | Term |
|---|---|
| D011818 | Rabies |
| ID | Term |
|---|---|
| D018353 | Rhabdoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| 200 µg CV7201 mRNA long | Experimental | Vaccination by injection on days 0, 28, 56. |
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| 400 µg CV7201 mRNA long | Experimental | Vaccination by injection on days 0, 28, 56. |
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Number of subjects discontinued from treatment after the first or second vaccination due to vaccination-related reactions or AEs/SAEs. Period for observation in order to decide on withdrawal of subjects from next vaccination starts with Visit 1 (day 0, first vaccination) and lasts until the day of the third scheduled vaccination (pre-vaccination examination). |
| up to 64 days after the last vaccination |
| D007239 | Infections |