Safety of Rabivax-S for Pre-exposure Prophylaxis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03741270|
Recruitment Status : Enrolling by invitation
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Rabies Vaccine Adverse Reaction||Biological: Rabivax-S||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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).
- 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.
- 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:
- 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.
- 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) ]
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
|Saint Kitts and Nevis|
|Ross University School of Veterinary Medicine|
|Basseterre, Saint Kitts and Nevis|
|Principal Investigator:||Darryn L Knobel, BVSc, PhD||Ross University School of Veterinary Medicine|