Rabies Immunization Concomitant With JEV in Children

NCT ID: NCT00703521

Last Updated: 2008-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-08-31
• Study Completion Date: 2005-09-30

Brief Summary

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).

Conditions

Rabies

Keywords

rabies vaccination; pre-exposure prophylaxis; rabies virus neutralizing antibody; Antibody response; immunologic memory of rabies vaccination; Safety of rabies vaccination administered in pre-exposure regimens both intramuscular and intradermal routes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1,2,3,4,5

1. Rabies vaccine 1.0 mL IM on day 0, 7, 28,and 1 year

2. Rabies vaccine 0.5 mL IM on day 0, 7, 28,and 1 year

3. Rabies vaccine 0.1 mL Intradermal on day 0, 7, 28,and 1 year

4. Rabies vaccine 0.1 mL Intradermal on day 0, 28,and 1 year

5. Japanese encephalitis vaccine 0.25 mL subcutaneous

Group Type: PLACEBO_COMPARATOR

Rabies vaccine

Intervention Type: BIOLOGICAL

1.0 mL IM day 0,7,28 and 1 year

Interventions

Rabies vaccine

1.0 mL IM day 0,7,28 and 1 year

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Male and female 12-18 months old toddlers will be included in the study if they;
• are in good health at time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator;
• are available for all the visits scheduled in the study;
• have been granted a written informed consent signed by their parents

Exclusion Criteria

• a history of rabies immunization;
• a history of Japanese encephalitis immunization or disease;
• a significant acute or chronic infectious disease at the time of enrollment;
• fever > 38.0 degree C (axillary) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment;
• being under treatment with parenteral, oral and/or inhaled corticosteroids, immunosuppressive drugs or other specific anti-inflammatory drugs or having taken chloroquine during the two months period before enrollment;
• administration of any vaccine within the past 14 days before enrollment;
• known immunodeficiency or an autoimmune disease;
• known hypersensitivity to neomycin, tetracycline, amphotericin-B;
• planned surgery during the study period;
• being enrolled in any other investigational trial contemporaneously;
• the family plans to leave the area of the study site before the end of study period;
• history of febrile convulsions;
• history of wheezing

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chiron company: Clinical Research and Medical Affairs

UNKNOWN

Sponsor Role: collaborator

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Department of Tropical Pediatrics

Other Identifiers

M49P2

Identifier Type: -

Identifier Source: org_study_id