Safety and Effectiveness of BPL HRIG With Active Rabies Vaccine in Healthy Subjects

Completed · Phase 2/Phase 3

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT03264157

Run by

Bio Products Laboratory

People needed

162

Starts

2017-12-08

Expected to finish

2018-07-13

Last updated by the study team

2020-02-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• 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.
• History of or ongoing bleeding disorder.
• Previous organ transplant recipient.
• Ongoing immunosuppressive illness.
• Clinically significant illnesses including: cardiac, hepatic, renal, endocrine, neurological, hematological, neoplastic, immunological, skeletal or other) that in the opinion of the investigator, could interfere with the safety, compliance or other aspects of this study.
• All types of malignancies except for basal and squamous cell (scaly or plate-like) skin cancer, in- situ cervical carcinoma must be in remission for a minimum of 5 years prior to Day 0. For non-melanoma skin cancers and carcinoma in-situ of the cervix may be enrolled if treated and cured at the time of screening.
• Evidence of active systemic infection that requires treatment with antibiotics within 2 weeks prior to Day 0.
• Currently receiving or have received within the past 6 months (prior to Day 0):
• immunosuppressive drugs
• immunomodulatory drugs
• Currently receiving or have received oral or IV steroids within 14 days (prior to DAY 0) or expected to require oral or IV steroids during the study.
• Evidence of uncontrolled hypertension (systolic blood pressure of >150 mmHg, and/or diastolic blood pressure of >100 mmHg).
• Heart rate >120/min.
• Weight > 95.5 kg
• History of IgA deficiency.
• Is positive for any of the following at screening: serological test for HIV 1\&2, HCV or HBsAg.
• Presence of psychiatric disorder, other mental disorder or any other medical disorder which might impair the subject's ability to give informed consent or to comply with the requirements of the study protocol.
• Previous enrollment in this study.

Where it is running

• Prism Research — Saint Paul, Minnesota, United States
• Wake Research Associates — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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