Early Rabies Vaccine Immunization in Primary School Children (I49P1)

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)

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.

Study Overview

• Status: Completed
• Conditions: Rabies Prevention
• Intervention / Treatment: Biological: rabies vaccine

• Study Type: Interventional
• Enrollment (Actual): 703
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Phetchabun, Thailand
    • Phetchabun Province primary schools

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 8 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 2 primary ID doses; two doses of rabies vaccines given intradermally on days 0 and 28	Biological: rabies vaccine; intradermal vaccination; Other Names: PCECV, Rabipur
EXPERIMENTAL: 3 primary ID doses; three doses of rabies vaccines given intradermally on days 0, 7, and 28	Biological: rabies vaccine; intradermal vaccination; Other Names: PCECV, Rabipur

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rabies virus neuralizing antibody, assessed by RFFIT	rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT)	seven days after the first booster dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rabies virus neuralizing antibody, assessed by RFFIT	rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT)	one year after the first booster dose
rabies virus neuralizing antibody, assessed by RFFIT	rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT)	immediately before administration of the first booster dose

Collaborators and Investigators

• Sponsor: Provincial Public Health Office, Phetchabun
• Investigators: Principal Investigator: Thavatchai Kamoltham, MD, Provincial PHO

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2002
• Primary Completion (ACTUAL): November 1, 2004
• Study Completion (ACTUAL): November 1, 2008

Study Registration Dates

• First Submitted: April 16, 2010
• First Submitted That Met QC Criteria: April 19, 2010
• First Posted (ESTIMATE): April 20, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): April 20, 2010
• Last Update Submitted That Met QC Criteria: April 19, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: children; Rabies; intradermal; PCECV; pre-exposure immunization
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Mononegavirales Infections; Rhabdoviridae Infections; Rabies
• Other Study ID Numbers: I49P1