Safety of Rabivax-S for Pre-exposure Prophylaxis

Ross University School of Veterinary Medicine

Status and phase: Completed; Phase 4

Conditions: Rabies Vaccine Adverse Reaction

Treatments: Biological: Rabivax-S

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03741270

18-13-EX

Details and patient eligibility

About

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.

Enrollment: 159 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

A DVM student registered at RUSVM will be eligible for inclusion in the study if the student is:

1. in the 7th semester of the DVM program, or
2. is in the 5th or 6th semester of the DVM program and is planning to undertake a veterinary externship in the following semester break that would require pre-exposure prophylaxis to rabies.

Exclusion criteria

A DVM student who meets the inclusion criteria will be excluded from the study if the student:

1. has previously received a dose of rabies vaccine, or
2. has any condition for which rabies vaccination is contra-indicated, or
3. does not provide informed consent for participation.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

159 participants in 1 patient group

Vaccine

Experimental group

Treatment:

Biological: Rabivax-S