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 used for rabies immunization, including pre-exposure and simulated post-exposure prophylaxis in healthy volunteers. It is a rabies vaccine developed by Sanofi. The Phase 3 study of HDCV enrolled 570 participants aged 2 years and older in the Philippines.
HDCV is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating HDCV for rabies immunization.
HDCV is in Phase 3 development for rabies immunization. One Phase 3 trial has been completed, and no trials are currently active. The completed study was randomized, active-controlled, and enrolled 570 participants.
HDCV has been evaluated in the Phase 3 trial NCT03700242, titled Imovax Rabies and VERORAB Immunogenicity and Safety After One Week 2-sites Intradermal or 1-site Intramuscular Pre-Exposure Prophylaxis Regimens, Followed by a Simulated Post-Exposure Prophylaxis Regimen at One Year. The trial is completed and enrolled 570 healthy volunteers in the Philippines.
HDCV is an investigational product in clinical development and has not been shown to be FDA approved. Its development stage is Phase 3, with one completed trial for rabies immunization. No active trials are ongoing.
HDCV is a monoclonal antibody. It is designed to target the rabies virus for immunization purposes. The completed Phase 3 trial evaluated its immunogenicity and safety in healthy volunteers aged 2 years and older.