Rabies Vaccine Adverse ReactionPhase 4NCT03741270
Safety of Rabivax-S for Pre-exposure Prophylaxis
A Phase 4 study testing Rabivax-S in people with Rabies Vaccine Adverse Reaction, run by Ross University School of Veterinary Medicine at 1 site in Saint Kitts and Nevis.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rabies Vaccine Adverse Reaction
- What is being tested?
- Rabivax-S
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteSaint Kitts and Nevis
- Study dates
- 24 Oct 2018to 28 Mar 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A DVM student registered at RUSVM will be eligible for inclusion in the study if the student is:
- 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.
Who cannot join
- A DVM student who meets the inclusion criteria will be excluded from the study if the student:
- 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.
Trial locations and contacts
1 site in 1 country.
Saint Kitts and Nevis1 site
Ross University School of Veterinary Medicine
Basseterre
About this study
Official title: Safety of Rabivax-S in Individuals Receiving Pre-exposure Prophylaxis (PrEP)
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
- Being tested
- Rabivax-S
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabivax-SBiological
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).
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Experimental | Not described Receives: Biological: Rabivax-S |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through 4 days after each dose
Secondary outcomes (5)
Number of unsolicited adverse events during 28 days after the first dose
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:
- results in death;
- is life-threatening;
- requires inpatient hospitalization;
- results in a persistent or significant disability/incapacity;
- results in a congenital anomaly/birth defect; or
- 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.
Measured: Through 28 days after the first dose given (day 0)
Number of serious adverse events during 28 days after the first dose
Measured: 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
Measured: 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
Measured: 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
Measured: Through 4 days after second dose (days 21-24 or days 28-31)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start24 Oct 2018
- Primary completion28 Mar 2019
- Study completion28 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rabies Vaccine Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ross University School of Veterinary Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Serum Institute of India Pvt. Ltd.
- Responsible party
- Principal investigator, Darryn Knobel, Ross University School of Veterinary Medicine
- Investigators
- Darryn L Knobel, BVSc, PhD, Principal investigator, Ross University School of Veterinary Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741270
- Sponsor's protocol ID
- 18-13-EX
- Status last verified
- Sep 2019
- First submitted
- 6 Nov 2018
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Rabivax-S in Individuals Receiving Pre-exposure Prophylaxis (PrEP)
- ClinicalTrials.gov ID
- NCT03741270
- Acronym / sponsor ID
- 18-13-EX
- Conditions
- Rabies Vaccine Adverse Reaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Ross University School of Veterinary MedicineUniversity, hospital or other
- Collaborators
- Serum Institute of India Pvt. Ltd.
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 28 Mar 2019 (actual)
- Study completion
- 28 Mar 2019 (actual)
- First posted
- 14 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccine | Experimental | Biological: Rabivax-S |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- A DVM student registered at RUSVM will be eligible for inclusion in the study if the student is:
- 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.
Key exclusion criteria (4 listed)
- A DVM student who meets the inclusion criteria will be excluded from the study if the student:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rabivax-SRabivax-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). | Biological | Vaccine |
Primary outcome
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.
5 secondary outcomes
Number of unsolicited adverse events during 28 days after the first dose
Time frame: Through 28 days after the first dose given (day 0)
Number of serious adverse events during 28 days after the first dose
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through 4 days after second dose (days 21-24 or days 28-31)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darryn L Knobel, BVSc, PhD principal investigator
Ross University School of Veterinary Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rabivax-S in people with Rabies Vaccine Adverse Reaction, run by Ross University School of Veterinary Medicine at 1 site in Saint Kitts and Nevis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saint Kitts and Nevis. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.