Immunogenicity and Safety of Verorab® in a "One-week" Intradermal Post-exposure Prophylaxis Regimen

Summary

The purpose of this study is to assess the 4-site "one-week" post-exposure prophylaxis (PEP) regimen as a possible alternative to the 2-site updated Thai Red Cross (TRC) PEP regimen. Primary objective: * To demonstrate that PEP using the new "one-week, 4-site" (4-4-4-0-0) intradermal (ID) vaccination regimen is non-inferior to PEP using the updated TRC (2-2-2-0-2) ID vaccination regimen. Secondary objectives: * Primary immunization: To describe the immune response in each group at Day 0, Day 14 and Day 90. * Antibody persistence: To describe rabies virus-neutralizing antibody persistence during the 5 years after completion of PEP in each group. * Booster vaccination: To describe the immune response induced by a single-visit 4-site intradermal booster vaccination in each group at Year 5. * Safety: To describe the safety profile of each group after the primary and booster vaccinations.

Timeline

Start

2012-06-29

Primary completion

2018-11-14

Completion

2018-11-14

Outcome

Met primary endpoint

paper seroconversion rates were non-inferior in both comparisons PMID 30890382 ↗

Publications

• Quiambao BP, Ambas C, Diego S, Bosch Castells V, Korejwo J, Petit C, Houillon G. Intradermal post-exposure rabies vaccination with purified Vero cell rabies vaccine: Comparison of a one-week, 4-site regimen versus updated Thai Red Cross regimen in a randomized non-inferiority trial in the Philippines. Vaccine. 2019 Apr 10;37(16):2268-2277. doi: 10.1016/j.vaccine.2019.02.083. Epub 2019 Mar 16.

Drugs

Indications