Safety of Rabivax-S for Pre-exposure Prophylaxis

NCT03741270 | Completed Phase 4

• 1 other identifier: 18-13-EX
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Rabies Vaccine Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• Number of participants with at least one solicited adverse event (AE) within 4 days after any dose

  Based on the package insert for Rabivax-S, the following adverse events will be solicited: * Local reactions (limited to the site of the injection): pain, erythema, oedema, pruritus and induration. * Systemic reactions: fever, shivering, malaise, asthenia, faintness, dizziness, headache, myalgia, arthralgia, nausea and abdominal pain. * Hypersensitivity or allergic reactions: anaphylaxis, urticaria, rash and erythema multiforme.

  Through 4 days after each dose

Secondary Outcomes (5)

• Number of unsolicited adverse events during 28 days after the first dose

  Through 28 days after the first dose given (day 0)

• Number of serious adverse events during 28 days after the first dose

  Through 28 days after the first dose given (day 0)

• Number of participants with at least one solicited adverse event (AE) within 4 days after first dose

  Through 4 days after first dose (days 0-3)

• Number of participants with at least one solicited adverse event (AE) within 4 days after second dose

  Through 4 days after second dose (days 7-10)

• Number of participants with at least one solicited adverse event (AE) within 4 days after third dose

  Through 4 days after second dose (days 21-24 or days 28-31)

Study Arms (1)

Vaccine

EXPERIMENTAL

Biological: Rabivax-S

Interventions

Rabivax-S BIOLOGICAL

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).

Vaccine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• in the 7th semester of the DVM program, or
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ross University School of Veterinary Medicine: lead
• Serum Institute of India Pvt. Ltd.: collaborator

Study Sites (1)

Ross University School of Veterinary Medicine

Basseterre, Saint Kitts and Nevis

Location

Study Officials

• Darryn L Knobel, BVSc, PhD

  Ross University School of Veterinary Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Epidemiology and Population Health

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 14, 2018
• Study Start: October 24, 2018
• Primary Completion: March 28, 2019
• Study Completion: March 28, 2019
• Last Updated: September 24, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

SA (1)