Clinical trial NCT01107275: Early Rabies Vaccine Immunization in Primary School Children
Official title: Compare Immunogenicity, Safety and Long-term Booster Response After Primary Vaccination With 2 Intradermal Doses Versus 3 Intradermal Doses of PCEC Rabies Vaccine (Rabipur) in Healthy School Children in Thailand (5-8 Years of Age)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rabies Prevention
Keywords: Rabies
PCECV
pre-exposure immunization
intradermal
children
Lead sponsor: Provincial Public Health Office, Phetchabun
Sponsor class: OTHER_GOV
First posted: 2010-04-20
Enrollment: 703
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 700 male and female healthy school-children (age 5 to 8) in Thailand were randomized to receive 2 or 3 primary rabies vaccine doses (PCECV, Rabipur) given intradermally in a dose of 0.1mL into the skin in the deltoid region. In a subset of 100 children blood was taken for rabies virus neutralizing antibody determination on day 49. All subjects were randomized to receive 2 booster doses (the recommended vaccination schedule for pre-immunized individuals in case of an exposure) on days 0 and 3, one, three or five years later. Blood was taken before and after booster for up to one year.Safety and tolerability of the vaccine was assessed and persistence of immune response up to 1 year after the booster doses.


Eligibility criteria: Inclusion criteria:

Male and female 5-8 years old school children will be included in the study if:

* Their parents or legal guardians have given the written informed consent prior to study entry;
* They are in good health at time of study entry as determined by medical history, physical examination and clinical judgment of the investigator;
* They are available for all the visits scheduled in the study.

Exclusion criteria:

Subjects are not to be enrolled into the study if:

* They have a history of rabies immunization;
* They have an acute infectious disease at the time of study entry;
* They are under treatment with parenteral and/or oral steroids, immunosuppressive drugs, phenytoin or other specific anti-inflammatory drugs, or have taken chloroquine during the two month period before enrolment;
* They have a known immunodeficiency or an autoimmune disease;
* They have a known hypersensitivity to neomycin, tetracycline or amphotericin-B;
* They have planned surgery during the first study period (49 days);
* They are participating in any other trial of an investigational agent;
* They have any condition which in the opinion of the investigator, might interfere with the evaluation of the study objectives.
* The family plans to leave the area of the study site before the end of the study period.

Primary outcomes:
measure: rabies virus neuralizing antibody, assessed by RFFIT
timeFrame: seven days after the first booster dose
Secondary outcomes:
measure: rabies virus neuralizing antibody, assessed by RFFIT
timeFrame: one year after the first booster dose
measure: rabies virus neuralizing antibody, assessed by RFFIT
timeFrame: immediately before administration of the first booster dose
Other outcomes:
Locations:
city: Phetchabun
country: Thailand
facility: Phetchabun Province primary schools
Study officials:
affiliation: Provincial PHO
name: Thavatchai Kamoltham, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kamoltham T, Thinyounyong W, Phongchamnaphai P, Phraisuwan P, Khawplod P, Banzhoff A, Malerczyk C. Pre-exposure rabies vaccination using purified chick embryo cell rabies vaccine intradermally is immunogenic and safe. J Pediatr. 2007 Aug;151(2):173-7. doi: 10.1016/j.jpeds.2007.02.044.