Safety and Effectiveness of BPL HRIG With Active Rabies Vaccine in Healthy Subjects (NCT03264157) | Clinical Trial Compass
CompletedPhase 2/3
Safety and Effectiveness of BPL HRIG With Active Rabies Vaccine in Healthy Subjects
United States162 participantsStarted 2017-12-08
Plain-language summary
A prospective, randomized, blinded, parallel-group, non-inferiority, phase II/III study of the safety and effectiveness of simulated post-exposure prophylaxis with BPL HRIG with co-administration of active rabies vaccine in healthy subjects.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Able and willing to sign an informed consent form.
✓. Healthy male or female subjects aged 18 - 75 years inclusive.
✓. No previous exposure to rabies virus, rabies vaccine and/or rabies immunoglobulin.
✓. No significant abnormalities in hematology, biochemistry, or urinalysis according to the Principal Investigator's judgment.
✓. No significant abnormalities in ECG according to the Investigator's judgment.
✓. Females of child-bearing potential (defined from the onset of menstruation to one-year post- menopause and not surgically sterilized) who are (or become) sexually active must agree to practice contraception by using a highly effective (\>98%) method for the duration of the study.
✓. Females of child-bearing potential (defined from the onset of menstruation to one-year post- menopause and not surgically sterilized) must have a negative result on a serum at screening visit and a urine HCG-based pregnancy test at Day 0.
Exclusion criteria
✕. Female subjects who are pregnant and/or lactating.
✕. History of live virus vaccination, e.g., measles, mumps, varicella or rubella vaccine, within the last 3 months.
✕. Planned live virus vaccination, e.g., measles, mumps, varicella or rubella vaccine, within the 3 months after Day 0.
✕. History of anaphylactic or anaphylactoid hypersensitivity reactions to chicken egg; history of mild allergic reactions to chicken egg, e.g., skin rash only, is not an exclusion criterion
What they're measuring
1
Proportion of Subjects With Anti-rabies Antibody Titer of ≥0.5 IU/mL
✕. History of hypersensitivity reaction to any of the following components of active rabies vaccine (US-FDA approved) e.g.: neomycin, bovine gelatin, trace amounts of chicken protein, chlortetracycline, and amphotericin B and in accordance with the product insert of the vaccine.
✕. History of life-threatening allergy, anaphylactic reaction, or systemic response to human plasma derived products.
✕. History of life-threatening allergy to blood or blood products.
✕. Fever at the time of the start of the injection (oral temperature \>38ºC.) or acute illness at the time of the start of the injection. Subjects with fever on Day 0 may have entry to the study re-scheduled.