Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HDCV · 1 trial · 1 indication
Rabies virus neutralizing antibodies (RVNA) titer ≥ 0.5 IU/mL
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | 1 IM dose of human diploid cell vaccine (HDCV) on D0 and D7 (short HDCV IM PrEP regimen), followed by 1 IM dose of HDCV on Year (Y)1 and Y1 + 3 days |
| Group 2 | ACTIVE_COMPARATOR | 1 IM dose of HDCV on D0, D7, and D21 (reference), followed by 1 IM dose of HDCV on Y1 and Y1 + 3 days |
| Group 3 | EXPERIMENTAL | 2 intradermal (ID) doses of HDCV on D0 and D7 (short HDCV ID PrEP regimen), followed by 1 ID dose of HDCV on Y1 and Y1 + 3 days |
| Group 4 | EXPERIMENTAL | 1 IM dose of purified Vero cell rabies vaccine (PVRV) on D0 and D7 (short PVRV IM PrEP regimen), followed by 1 IM dose of PVRV on Y1 and Y1 + 3 days |
| Group 5 | EXPERIMENTAL | 2 ID doses of PVRV on D0 and D7 (short PVRV ID PrEP regimen), followed by 1 ID dose of PVRV on Y1 and Y1 + 3 days |
| Name | Type | Description |
|---|---|---|
| HDCV | BIOLOGICAL | Pharmaceutical form:Solution for injection Route of administration: Intramuscular |
| PVRV | BIOLOGICAL | Pharmaceutical form:Solution for injection Route of administration: Intramuscular |
Inclusion criteria : * Aged ≥ 2 years on the day of inclusion * Participant aged \< 18 years: Assent form has been signed and dated by the subject (as appropriate, according to country-specific institution requirements), and informed consent form (ICF) signed and dated by the parent or another lega...
HDCV is a rabies vaccine used for pre-exposure prophylaxis in healthy volunteers. It is being studied for immunization against rabies, with a focus on evaluating different dosing regimens for protection before potential exposure to the virus.
HDCV is developed by Sanofi, a global biopharmaceutical company traded on the stock exchange under the ticker SNY. Sanofi is responsible for the research and clinical development of this rabies vaccine.
HDCV is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved for public use and is still undergoing clinical trials to assess its safety and efficacy.
HDCV is being studied in a Phase 3 clinical trial with the identifier NCT03700242. This trial, which has been completed, enrolled 570 participants and evaluated the immunogenicity and safety of different pre-exposure prophylaxis regimens for rabies immunization.
HDCV is being studied in a clinical trial that compares it to Imovax Rabies and VERORAB. The trial evaluates the immunogenicity and safety of HDCV against these other rabies vaccines, but HDCV itself is a distinct vaccine product.