Rabies Immunization Concomitant With JEV in Children

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).

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Key information

Conditions

Rabies Infections Mononegavirales Infections RNA Virus Infections Rhabdoviridae Infections Virus Diseases

Age range

12 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rabies vaccine

Biological

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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

Chiron company: Clinical Research and Medical Affairs

Registry information

Official study 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

Important dates

Study start: 2002
Primary completion: 2002
Study completion: 2005
First posted: Jun 23, 2008
Registry last updated: Oct 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed