Study of Purified Vero Rabies Vaccine Compared With Two Reference Rabies Vaccines in a Simulated Post-Exposure Regimen in Adults
Summary
Primary Objective: To demonstrate that Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) was non-inferior to Verorab and Imovax Rabies vaccines when co-administered with human rabies immunoglobulin (HRIG), in terms of proportion of participants achieving a rabies virus neutralizing antibody (RVNA) titer greater than or equal to (\>=) 0.5 international units per milliliter (IU/mL) at Day 28, i.e., 14 days after the fourth vaccine injection. Secondary Objective: * To describe the safety profile of VRVg-2 versus Verorab and Imovax Rabies vaccines when co-administered with HRIG, as well as that of VRVg-2, after each vaccine injection. * To demonstrate that the proportion of participants in the VRVg-2 + HRIG group achieving an RVNA titer \>= 0.5 IU/mL at Day 28 was at least 95 percent (%). * To describe the immune response induced by VRVg-2 versus Verorab and Imovax Rabies vaccines when co-administered with HRIG, as well as that induced by VRVg-2, at Day 14 (7 days after the third injection), at Day 28 (14 days after the fourth injection) and at Day 42 (14 days after the last injection).
Timeline
- Start
- 2019-07-01
- Primary completion
- 2020-12-22
- Completion
- 2021-07-01
Outcome
Met primary endpoint
paper Non-inferiority of PVRV-NG2 + HRIG compared with PVRV + HRIG and HDCV + HRIG was demonstrated. PMID 38478634 ↗
registry Difference in Percentage -0.42 (95% CI -2.33 to 4.35) NCT03965962 ↗
registry Difference in Percentage 0.86 (95% CI -1.32 to 6.50) NCT03965962 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Imovax® Rabies | Vaccine | 1 ml | Intramuscular |
| Subject | VRVg-2 | Vaccine | 0.5 ml | Intramuscular |
| Comparator | Verorab | Vaccine | 0.5 ml | Intramuscular |
| Background | HyperRAB | Unknown | — | Intramuscular |
Indications
No indication recorded.