Rabies Prevention Clinical Trial
Official title:
A Single Center, Open-Label, Study of Intradermal Administration of an Inactivated PCEC Rabies Vaccine in Adult Subjects
The purpose of this study is to determine immunogenicity and safety of intradermal administration of the PCEC rabies vaccine in adults.
Approximately 16,000-39,000 persons come in contact with potentially rabid animals and
receive rabies postexposure prophylaxis (PEP) each year in the US. To appropriately manage
potential human exposures to rabies, the risk for infection must be accurately assessed.
Administration of rabies PEP is a medical urgency, not a medical emergency, but decisions
must not be delayed. Prophylaxis is occasionally complicated by adverse reactions, but these
reactions are rarely severe. Current data on the safety and efficacy of active and passive
rabies vaccination were derived from both human and animal studies. Timely and appropriate
human pre-exposure prophylaxis (Pre-EP) and PEP will prevent human rabies. Currently in the
US, the approved dosage and administration for PEP in previously unvaccinated persons
consists of the administration of vaccine (HDCV or PCECV) and HRIG. Vaccine is administered
IM on days 0, 3, 7, 21, and 28 (deltoid area). The approved dosage and administration for
pre-exposure prophylaxis (Pre-EP) consists of three 1.0-mL injections of vaccine (HDCV or
PCECV) administered IM (deltoid area), one injection per day on days 0, 7, and 21 or 28).
Intradermal (ID) route of administration of rabies vaccination is used in certain countries
both for PEP and Pre-EP, and approved by WHO for modern potent cell culture vaccines. Recent
studies outside the USA found the use of PCEC rabies vaccine by ID administration
immunogenic and safe.
The primary goals of this study are to obtain additional safety and immunogenicity data on
ID administration of 0.1 mL doses of the inactivated PCEC rabies virus vaccine in adults.
Given the need to provide alternative routes of administration to the current approved
intramuscular route in order to protect a larger number of people facing potential vaccine
shortages. The data yielded by this clinical trial will provide evidence to support
alternative route of administration and dose of PCECV in the US.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01107275 -
Early Rabies Vaccine Immunization in Primary School Children
|
Phase 3 |