NCT03741270

Safety of Rabivax-S for Pre-exposure Prophylaxis

Safety of Rabivax-S in Individuals Receiving Pre-exposure Prophylaxis (PrEP)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Ross University School of Veterinary Medicine · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

People who are at frequent or continuous risk of exposure to rabies virus should be vaccinated against the disease (pre-exposure prophylaxis). This includes people who work with rabies virus in research or diagnostic laboratories or vaccine production facilities, veterinarians, staff, animal-control and wildlife workers in areas where rabies is endemic. Veterinary students in clinical placements and externships are included in this category. Currently, DVM students at Ross University School of Veterinary Medicine (RUSVM) are vaccinated against rabies in their 7th semester (final pre-clinical semester). Vaccinations are done by RUSVM Health Services using Rabivax-S, produced by the Serum Institute of India (study co-sponsors). Previously-unvaccinated students receive three injections of vaccine, on day 0, 7 and 21-28. The aim of the study is to generate additional data on safety and tolerability of Rabivax-S administered as pre-exposure prophylaxis to this population.

Conditions

• Rabies Vaccine Adverse Reaction

Interventions

Type	Name	Description
BIOLOGICAL	Rabivax-S	Rabivax-S is a lyophilized vaccine manufactured by Serum Institute of India Pvt. Ltd. containing inactivated purified rabies antigen (Pitman Moore, PM3218 as virus strain) produced using Vero ATCC CCL 81 cells. The diluent (sterile water for injection) is provided in a separate 1 mL ampoule. After reconstitution, a single dose of 1 mL contains an inactivated, purified rabies antigen (not less than 2.5 IU), glycine (40 mg), sucrose (40 mg) and human serum albumin (25% 10 mg). The intervention is administered by intramuscular injection of 1 mL reconstituted vaccine in the deltoid area of the upper arm, on days 0, 7 and 21 (or 28).

Timeline

• Start date: 2018-10-24
• Primary completion: 2019-03-28
• Completion: 2019-03-28
• First posted: 2018-11-14
• Last updated: 2019-09-24

Locations

1 site across 1 country: Saint Kitts and Nevis