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Boosterability of Live Attenuated Japanese Encephalitis (JE) Vaccine in Children Who Have Previously Received Inactivated JE Vaccine

This study has been completed.
Sponsor:
Information provided by:
PATH
ClinicalTrials.gov Identifier:
NCT00463476
First received: April 18, 2007
Last updated: May 4, 2009
Last verified: April 2009
  Purpose

Japanese encephalitis virus is the leading cause of viral neurological disease and disability in Asia. The severity of sequelae, together with the volume of cases, make JE the most important cause of viral encephalitis in the world. Approximately 3 billion people—including 700 million children—live in areas at risk in Asia for JE. JE most commonly infects children between the ages of 1 and 15 years, and can also infect adults in areas where the virus is newly introduced. More than 50,000 cases are reported annually and cause an estimated 10,000 to 15,000 deaths. This figure is believed to represent only a small proportion of the disease burden that actually exists.

An inactivated JE vaccine is currently being used in Sri Lanka. It is given to children in 3 doses, at 12 months of age, 13 months of age, and 2 years of age. A booster dose must also be given to children at 5 years of age. If Sri Lanka decides to replace the inactivated JE vaccine with the live attenuated JE vaccine, there will be many children who still need a 3rd or booster dose of the inactivated JE vaccine. This research study is being done to see if the live attenuated vaccine will work well to replace the inactivated JE vaccine and if it is safe in Sri Lankan children.


Condition Intervention Phase
Japanese Encephalitis
Biological: Japanese encephalitis live attenuated SA 14-14-2 vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Assessment of the Immunogenicity and Safety of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine in Children in Sri Lanka

Resource links provided by NLM:


Further study details as provided by PATH:

Primary Outcome Measures:
  • The proportion of subjects with demonstrated seropositivity for JE at 28 days postimmunization with live attenuated JE vaccine

Secondary Outcome Measures:
  • Geometric mean titer (GMT) of serum antibody to JE among subjects at 28 days postimmunization with live attenuated JE vaccine
  • proportion of subjects with immediate reactions (within 30 minutes after injection, with emphasis on allergic reactions)
  • proportion of subjects with local and systemic reactions (including unsolicited events) measured during the first 7 days following vaccination
  • proportion of subjects with adverse events (AEs) (related or unrelated to vaccination) occurring from Day 8 to Day 28
  • serious adverse events (SAEs) (related or unrelated to vaccination) occurring from Day 0 to Day 365
  • the proportion of subjects with demonstrated seropositivity for JE at 365 days postimmunization with live attenuated JE vaccine
  • geometric mean titer (GMT) of serum antibody to JE among subjects at 365 days postimmunization with live attenuated JE vaccine

Estimated Enrollment: 306
Study Start Date: July 2007
Study Completion Date: April 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy child 2 years (±3 months) or 5 years (±3 months) of age at the enrollment visit.
  • Subject was a full-term infant.
  • Subject's parent or legal guardian is literate and willing to provide written informed consent.
  • Subject is up-to-date for all vaccinations recommended in the Sri Lankan childhood immunization schedule.

Exclusion Criteria:

  • Enrolled in another clinical trial involving any therapy.
  • Subject and/or parent(s) or guardian(s) are unable to attend the scheduled visits or comply with the study procedures.
  • Received any non-study vaccine within 2 weeks prior to enrolment or refusal to postpone receipt of such vaccines until 28 days after study entry.
  • Prior or anticipated receipt of immune globulin or other blood products, or injected or oral corticosteroids or other immune modulator therapy except routine vaccines within 6 weeks of administration of study vaccine. Individuals on a tapering dose schedule of oral steroids lasting <7 days may be included in the trial as long as they have not received more than one course within the last 2 weeks prior to enrolment.
  • History of documented or suspected encephalitis, encephalopathy, or meningitis.
  • History of measles.
  • History of Japanese encephalitis.
  • Serious adverse event related (i.e., possible, probably, definite) to previous receipt of any JE vaccine, if applicable.
  • Persistent inconsolable crying (>3 hours) observed after previous receipt of any JE vaccine, if applicable.
  • Hypotonic - hyporesponsiveness after past receipt of any JE vaccine, if applicable.
  • Suspected or known hypersensitivity to any of the investigational or marketed vaccine components.
  • History of serious chronic disease (cardiac, renal, neurologic, metabolic, or rheumatologic).
  • Underlying medical condition such as inborn errors of metabolism, failure to thrive, bronchopulmonary dysplasia, or any major congenital abnormalities requiring surgery or chronic treatment.
  • History of thrombocytopenic purpura.
  • History of seizures, including history of febrile seizures, or any other neurologic disorder.
  • Known or suspected immunologic function impairment of any kind and/or known HIV infection.
  • Parent with known or suspected immunologic function impairment of any kind and/or known HIV infection.
  • Any condition that, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the study objectives.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463476

Locations
Sri Lanka
Homagama MOH Division Medical Office
Homagama, District of Colombo, Sri Lanka
Kolonnawa MOH Division Medical Office
Kolonnawa, District of Colombo, Sri Lanka
Moratuwa MOH Division Medical Office
Moratuwa, District of Colombo, Sri Lanka
Sponsors and Collaborators
PATH
Investigators
Principal Investigator: Nihal Abeysinghe, MD, MSc Epidemiological Unit, Sri Lanka Ministry of Healthcare and Nutrition
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00463476     History of Changes
Other Study ID Numbers: JEV04, HS382, EC/06/111
Study First Received: April 18, 2007
Last Updated: May 4, 2009
Health Authority: Sri Lanka: University of Colombo Faculty of Medicine Ethics Review Committee
Sri Lanka: Ministry of Healthcare & Nutrition

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
Arbovirus Infections
Brain Diseases
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Encephalitis, Arbovirus
Encephalitis, Viral
Flaviviridae Infections
Flavivirus Infections
Nervous System Diseases
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014