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Safety of Rabivax-S for Pre-exposure Prophylaxis

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ClinicalTrials.gov Identifier: NCT03741270
Recruitment Status : Enrolling by invitation
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
Serum Institute of India Pvt. Ltd.
Information provided by (Responsible Party):
Darryn Knobel, Ross University School of Veterinary Medicine

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.

Condition or disease Intervention/treatment Phase
Rabies Vaccine Adverse Reaction Biological: Rabivax-S Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety of Rabivax-S in Individuals Receiving Pre-exposure Prophylaxis (PrEP)
Actual Study Start Date : October 24, 2018
Estimated Primary Completion Date : April 11, 2019
Estimated Study Completion Date : April 11, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies

Arm Intervention/treatment
Experimental: Vaccine 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).




Primary Outcome Measures :
  1. Number of participants with at least one solicited adverse event (AE) within 4 days after any dose [ Time Frame: Through 4 days after each 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.


Secondary Outcome Measures :
  1. Number of unsolicited adverse events during 28 days after the first dose [ Time Frame: Through 28 days after the first dose given (day 0) ]

    Definitions of AEs and SAEs are taken from the OHRP's Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events.

    AE means any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.

    A SAE is any AE temporally associated with the subject's participation in research that meets any of the following criteria:

    1. results in death;
    2. is life-threatening;
    3. requires inpatient hospitalization;
    4. results in a persistent or significant disability/incapacity;
    5. results in a congenital anomaly/birth defect; or
    6. any other AE that, based upon appropriate medical judgment, may jeopardize the subject's health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.

  2. Number of serious adverse events during 28 days after the first dose [ Time Frame: Through 28 days after the first dose given (day 0) ]
  3. Number of participants with at least one solicited adverse event (AE) within 4 days after first dose [ Time Frame: Through 4 days after first dose (days 0-3) ]
  4. Number of participants with at least one solicited adverse event (AE) within 4 days after second dose [ Time Frame: Through 4 days after second dose (days 7-10) ]
  5. Number of participants with at least one solicited adverse event (AE) within 4 days after third dose [ Time Frame: Through 4 days after second dose (days 21-24 or days 28-31) ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741270


Locations
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Saint Kitts and Nevis
Ross University School of Veterinary Medicine
Basseterre, Saint Kitts and Nevis
Sponsors and Collaborators
Ross University School of Veterinary Medicine
Serum Institute of India Pvt. Ltd.
Investigators
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Principal Investigator: Darryn L Knobel, BVSc, PhD Ross University School of Veterinary Medicine

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Responsible Party: Darryn Knobel, Professor of Epidemiology and Population Health, Ross University School of Veterinary Medicine
ClinicalTrials.gov Identifier: NCT03741270     History of Changes
Other Study ID Numbers: 18-13-EX
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No