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CV7201 mRNA · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| 80 µg CV7201 mRNA short | EXPERIMENTAL | Vaccination by injection on days 0, 7, 28. |
| 160µg CV7201 mRNA short | EXPERIMENTAL | Vaccination by injection on days 0, 7, 28. |
| 80 µg CV7201 mRNA long | EXPERIMENTAL | Vaccination by injection on days 0, 28, 56. |
| 160 µg CV7201 mRNA long | EXPERIMENTAL | Vaccination by injection on days 0, 28, 56. |
| 320 µg CV7201 mRNA long | EXPERIMENTAL | Vaccination by injection on days 0, 28, 56. |
| 640 µg CV7201 mRNA long | EXPERIMENTAL | Vaccination by injection on days 0, 28. |
| 200 µg CV7201 mRNA long | EXPERIMENTAL | Vaccination by injection on days 0, 28, 56. |
| 400 µg CV7201 mRNA long | EXPERIMENTAL | Vaccination by injection on days 0, 28, 56. |
| Name | Type | Description |
|---|---|---|
| CV7201 mRNA | BIOLOGICAL | CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein. |
Inclusion Criteria: 1. Healthy male and female volunteers aged 18 to 40 years inclusive 2. Compliant with protocol procedures and available for clinical follow-up through the last planned visit (V9) 3. Physical examination and laboratory results without clinically significant findings 4. Body Mass ...
CV7201 mRNA is an investigational messenger RNA vaccine being developed for the prevention of rabies, a viral infection of the infectious disease therapeutic area. It is designed to induce an immune response against the rabies virus. The vaccine is currently in clinical development and is not yet approved for use.
CV7201 mRNA is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker symbol BNTX. The company is conducting clinical trials to evaluate the safety and immunogenicity of this investigational rabies vaccine in healthy adults.
CV7201 mRNA is in Phase 1 clinical development. It has completed a Phase 1 trial, and it remains an investigational drug, meaning it has not been approved by regulatory authorities. The completed trial enrolled 101 participants to assess the vaccine's safety and immune response.
CV7201 mRNA has been studied in one clinical trial, identified as NCT02241135, titled "RNActive® Rabies Vaccine (CV7201) in Healthy Adults." This Phase 1 study was completed and enrolled 101 participants in Germany. The trial included healthy volunteers aged 18 years and older.
CV7201 mRNA is an RNActive vaccine, which is a proprietary mRNA vaccine platform developed by BioNTech. The clinical trial for CV7201 mRNA is titled "RNActive® Rabies Vaccine (CV7201) in Healthy Adults," indicating that CV7201 is a specific rabies vaccine candidate built on the RNActive technology.