Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VRVg 2 · 2 trials · 2 indications
RVNA titer against rabies virus was assessed using the Rapid Fluorescent Focus Inhibition test (RFFIT) assay method.
RVNA GMT against rabies virus was assessed using the rapid fluorescent focus inhibition test (RFFIT) assay method.
RVNA GMT against rabies virus was assessed using the RFFIT assay method.
RVNA GMT against rabies virus was assessed using the RFFIT assay method.
RVNA GMT against rabies virus was assessed using the RFFIT assay method.
RVNA GMT against rabies virus was assessed using the RFFIT assay method.
RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \>=0.2 IU/mL were considered as seropositive.
RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \>=0.2 IU/mL were considered as seropositive.
RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \>=0.2 IU/mL were considered as seropositive.
RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \>=0.2 IU/mL were considered as seropositive.
RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \>= 0.2 IU/mL were considered as seropositive.
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 7 days post 3rd vaccination (i.e., on Day 14) and pre-vaccination on Day 0.
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 14 days post 4th vaccination (i.e., on Day 28) and pre-vaccination on Day 0.
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 14 days post 5th vaccination (i.e., on Day 42) and pre-vaccination on Day 0.
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 6 month post last vaccination on Month 7 and pre-vaccination on Day 0.
Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported.
Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported.
Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported.
Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported.
Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported.
An adverse event was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of diagnosis and/or onset post-vaccination. All participants were observed for 30 minutes after any vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF. Immediate AEs considered as related to vaccination were recorded as immediate unsolicited adverse reactions (ARs).
A solicited reaction (SR) was an AR observed and reported under conditions (symptoms and onset) prelisted (i.e., solicited) in the CRF and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited injection site reactions included pain, erythema and swelling at and around the injection site.
A solicited reaction was an AR observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited systemic reactions included fever, headache, malaise and myalgia.
An AE was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset post-vaccination.
An AE was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. An SAE was any untoward medical occurrence that at any dose resulted in death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect or a medically important event.
| Arm | Type | Description |
|---|---|---|
| Group 1: VRVg-2 + HRIG | EXPERIMENTAL | Participants received 0.5 milliliters (mL) intramuscular (IM) injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0. |
| Group 2: Verorab + HRIG | ACTIVE_COMPARATOR | Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0. |
| Group 3: Imovax Rabies + HRIG | ACTIVE_COMPARATOR | Participants received 1 mL IM injection of Imovax Rabies on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0. |
| Group 4: VRVg-2 | EXPERIMENTAL | Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28. |
| Group 1: VRVg-2 Formulation 1 | EXPERIMENTAL | VRVg-2 formulation 1, intramuscular (IM) injection on Days 0, 3, 7, 14 and 28. Concomitant administration of human rabies immunoglobulins (HRIG) on Day 0. |
| Group 2: VRVg-2 Formulation 2 | EXPERIMENTAL | VRVg-2 formulation 2, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. |
| Group 3: VRVg-2 Formulation 3 | EXPERIMENTAL | VRVg-2 formulation 3, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. |
| Group 4: VRVg-1 | EXPERIMENTAL | VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. |
| Group 5: Imovax Rabies | ACTIVE_COMPARATOR | Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. |
| Name | Type | Description |
|---|---|---|
| VRVg-2 | BIOLOGICAL | Pharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM |
| Purified Inactivated Rabies Vaccine | BIOLOGICAL | Pharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM |
| Human Diploid Cell Vaccine (HDCV) | BIOLOGICAL | Pharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM |
| Rabies immune globulin (human) | BIOLOGICAL | Pharmaceutical form: Solution for injection; Route of administration: IM |
| VRVg 2 | BIOLOGICAL | Modified formulation 1 (Low) of Purified Vero Rabies Vaccine Serum Free |
| VRVg 1 | BIOLOGICAL | Initial formulation of Purified Vero Rabies Vaccine Serum Free |
| Imovax Rabies | BIOLOGICAL | Purified inactivated rabies vaccine prepared on human diploid cell cultures |
| Human Rabies Immunoglobulins (HRIG) | BIOLOGICAL | Commercialized formulation of HRIG |
Inclusion criteria : * Men or women aged \>=18 years on the day of inclusion (\>= 18 years means from the day of the 18th birthday onwards, with no upper age limit). * Able to attend all scheduled visits and to comply with all trial procedures. * Body Mass Index (BMI): 18.5 kilograms per square met...
VRVg 2 is an investigational monoclonal antibody developed by Sanofi for rabies and rabies virus. It is being studied as a passive immunization agent in the infectious disease therapeutic area. The asset is in Phase 3 clinical development and has been evaluated in a completed Phase 3 trial and a completed Phase 2 trial.
VRVg 2 is being developed for rabies and rabies virus, with clinical evaluation in healthy adult volunteers under simulated post-exposure regimens. The Phase 3 study enrolled 640 participants in France and compared the regimen against two reference rabies vaccines. It is an investigational product and is not approved for use.
VRVg 2 is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating the monoclonal antibody in rabies and rabies virus indications. The program includes a completed Phase 3 trial and a completed Phase 2 trial.
VRVg 2 is in Phase 3 clinical development. The Phase 3 study, NCT03965962, has been completed and enrolled 640 participants in France. A Phase 2 study, NCT03145766, was also completed with 320 participants in the United States. VRVg 2 remains investigational and is not approved.
VRVg 2 has been evaluated in two completed clinical trials. NCT03965962 was a Phase 3 study of a purified Vero rabies vaccine in a simulated post-exposure regimen in adults, enrolling 640 participants in France. NCT03145766 was a Phase 2 immunogenicity and safety study enrolling 320 participants in the United States.
Yes, VRVg 2 and VRVg-2 refer to the same Sanofi monoclonal antibody asset being developed for rabies and rabies virus. The two spellings are alternative names for the same investigational product, which is in Phase 3 clinical development.