Clinical trial NCT03741270: Safety of Rabivax-S for Pre-exposure Prophylaxis
Official title: Safety of Rabivax-S in Individuals Receiving Pre-exposure Prophylaxis (PrEP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rabies Vaccine Adverse Reaction
Lead sponsor: Ross University School of Veterinary Medicine
Sponsor class: OTHER
Collaborators: name: Serum Institute of India Pvt. Ltd.
First posted: 2018-11-14
Enrollment: 159
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with at least one solicited adverse event (AE) within 4 days after any dose
timeFrame: Through 4 days after each dose
Secondary outcomes:
measure: Number of unsolicited adverse events during 28 days after the first dose
timeFrame: Through 28 days after the first dose given (day 0)
measure: Number of serious adverse events during 28 days after the first dose
timeFrame: Through 28 days after the first dose given (day 0)
measure: Number of participants with at least one solicited adverse event (AE) within 4 days after first dose
timeFrame: Through 4 days after first dose (days 0-3)
measure: Number of participants with at least one solicited adverse event (AE) within 4 days after second dose
timeFrame: Through 4 days after second dose (days 7-10)
measure: Number of participants with at least one solicited adverse event (AE) within 4 days after third dose
timeFrame: Through 4 days after second dose (days 21-24 or days 28-31)
Other outcomes:
Locations:
city: Basseterre
country: Saint Kitts and Nevis
facility: Ross University School of Veterinary Medicine
Study officials:
affiliation: Ross University School of Veterinary Medicine
name: Darryn L Knobel, BVSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: