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

Each subject will undergo a total of 9 visits. Subjects' eligibility will be assessed at
Screening, which can occur up to 28 days prior to dosing. Following a repeat eligibility
check at Day 0, eligible subjects will be randomized and dosed with the randomized treatment
(BPL HRIG /vaccine or Comparator HRIG/vaccine on Day 0. Further administration of assessments
will be conducted on Days 3, 5, 7, 14, 28, 49 and the end of study assessment on Day 140.

Inclusion Criteria:

- Able and willing to sign an informed consent form.

- Healthy male or female subjects aged 18 - 75 years inclusive.

- Not previously been immunized against rabies.

- 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.

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

- 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.

- 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 enrolment in this study.

- Participation in an interventional clinical trial within 30 days prior to baseline
visit (Day 0).

- Evidence of alcohol abuse or history of alcohol abuse or illegal and/or legally
prescribed drugs in the past 2 years.

- Any other factor that, in the opinion of the investigator, would prevent the subject
from complying with the requirements of the protocol.