Rabies Immunization Concomitant With JEV in Children - Full Text View

Sponsors and Collaborators:	Mahidol University Chiron company: Clinical Research and Medical Affairs
Information provided by:	Mahidol University
ClinicalTrials.gov Identifier:	NCT00703521

Purpose

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).

Condition	Intervention	Phase
Rabies	Biological: Rabies vaccine	Phase II

MedlinePlus related topics: Childhood Immunization Encephalitis Rabies

Drug Information available for: Immunoglobulins Globulin, Immune Japanese Encephalitis Vaccines Rabies Vaccine Rabies Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Mahidol University:

Estimated Enrollment:	200
Study Start Date:	August 2002
Study Completion Date:	September 2005
Primary Completion Date:	October 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1,2,3,4,5: Placebo Comparator Rabies vaccine 1.0 mL IM on day 0, 7, 28,and 1 year Rabies vaccine 0.5 mL IM on day 0, 7, 28,and 1 year Rabies vaccine 0.1 mL Intradermal on day 0, 7, 28,and 1 year Rabies vaccine 0.1 mL Intradermal on day 0, 28,and 1 year Japanese encephalitis vaccine 0.25 mL subcutaneous	Biological: Rabies vaccine 1.0 mL IM day 0,7,28 and 1 year

Eligibility

Ages Eligible for Study:	12 Months to 18 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Department of Tropical Pediatrics ( Prof. Arunee Sabchareon )
Study ID Numbers:	M49P2
Study First Received:	June 20, 2008
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00703521
Health Authority:	Thailand: Food and Drug Administration

Keywords provided by Mahidol University:

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 placed in the following topic categories:

Virus Diseases
Antibodies
Japanese encephalitis
Rabies

Encephalitis, Japanese
Encephalitis
Immunoglobulins

Additional relevant MeSH terms:

RNA Virus Infections
Rhabdoviridae Infections
Mononegavirales Infections

ClinicalTrials.gov processed this record on January 15, 2009