A Single Center, Open-Label, Study of Intradermal Administration of an Inactivated PCEC Rabies Vaccine in Adult Subjects (Rabies-ID)

NCT01044199 NA COMPLETED

The purpose of this study is to determine immunogenicity and safety of intradermal administration of the PCEC rabies vaccine in adults.

Details

Lead sponsor	Centers for Disease Control and Prevention
Phase	NA
Status	COMPLETED
Enrolment	130
Start date	2009-02
Completion	2013-08

Conditions

• Rabies Prevention
• Rabies Exposure

Interventions

• PCEC rabies vaccine given intradermally
• PCEC rabies vaccine administered intramuscularly

Primary outcomes

• Proportion of subjects who have virus-neutralizing antibody titers of at least 1:5 serum dilution by the RFFIT, 14 days after receipt of the last dose of the vaccine. — 14 days after receipt of the last dose of the vaccine.
  Proportion of subjects achieving rabies virus-neutralizing antibody titers ≥1:5 as measured by the rapid fluorescent focus inhibition test (RFFIT).
• Adverse event (AE) or serious adverse event (SAE) information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessment). — Imnediately after fisrt dose to completion of the study 6 months later.
  Incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) following vaccination, assessed through clinical evaluation and subject-reported outcomes.

Countries

United States