Rabies Clinical Trial
Official title:
A Three-Year Clinical Study on Immunogenicity, Safety and Booster Response of Purified Chick Embryo Cell Rabies Vaccine (Pcecv) Administered Intramuscularly or Intradermally to 12- to 18-Month-Old Thai Children Concomitantly With Japanese Encephalitis Vaccine
Background. The World Health Organization recommends pre-exposure vaccination (PreP) to
protect children living in canine rabies endemic countries. Including PreP in national
childhood immunization programs (EPI) is a viable option.
Methods. In an open-label phase II clinical trial, 200 healthy toddlers were randomized to
receive Purified Chick Embryo Cell Vaccine (PCECV) in a 3-dose Full-IM (1mL), Half-IM
(0.5mL), 3-ID (0.1mL), or a 2-dose 2-ID (0.1mL) regimen, all in combination with two doses
of Japanese Encephalitis (JEV), or JEV alone. One booster dose of PCECV (IM or ID) and JEV,
or JEV alone was administered concomitantly one year after primary vaccination. Safety was
evaluated after each injection. Blood was drawn on days 0 and 49, one year later prior to
booster and on days 7 and 28 post-booster, and at two and three years post primary
vaccination. All sera were analyzed for rabies and JE virus neutralizing antibodies (RVNA,
JEVNA).
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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