Determining Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles Vaccine

This study has been completed.
Sponsor:
Information provided by:
PATH
ClinicalTrials.gov Identifier:
NCT00249769
First received: November 3, 2005
Last updated: May 5, 2008
Last verified: May 2007
  Purpose

This study will determine whether it is safe and effective to administer Japanese encephalitis (JE) live attenuated SA 14-14-2 vaccine at the same time as measles vaccine. If it is found to be safe, it will pave the way for use in routine vaccination programs. The hypothesis is that children who receive JE live attenuated SA 14-14-2 vaccine and measles vaccine at the same time are protected against these diseases at the same level as those who receive the vaccines at different intervals.


Condition Intervention Phase
Encephalitis, Japanese B
Biological: Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Assessment of the Non-Inferiority of the Concurrent Administration of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine and Measles Vaccine Given Alone

Resource links provided by NLM:


Further study details as provided by PATH:

Primary Outcome Measures:
  • Seroconversion rates at one month post-vaccination for the measles antibody response in infants ages 8-11 months

Secondary Outcome Measures:
  • Seroconversion rates at one month post-vaccination for the JE antibody response in infants aged 8-11 months
  • Evaluation of the safety profiles of the concurrent administration of JE live attenuated SA 14-14-2 vaccine and measles vaccine in infants between 8 to 11 months of age compared to measles or JE vaccine given alone

Estimated Enrollment: 600
Study Start Date: November 2005
Estimated Study Completion Date: May 2006
Detailed Description:

Japanese encephalitis 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 Asian areas at risk 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 effective vaccine has existed since 1941, but has not reached the poorest countries in Asia. During the 60 years that the vaccine has been available, JE has infected an estimated 10.5 million children, resulting in more than 3 million deaths and more than 4 million children living with long-term disabilities. Control of this disease has been limited due to poor disease surveillance, a limited and unstable vaccine supply, lack of guidance and programmatic support for immunization, and limited advocacy.

A successful vaccine should be safe, efficacious, affordable, administered in a single dose, and easily incorporated into the routine Expanded Programmes on Immunization (EPI) programs. This study will help ensure the safety of SA 14-14-2 simultaneously administered with measles vaccine, paving the way for its use in routine EPI programs. If this candidate becomes widely available, it will drastically increase the feasibility of routine JE immunization in Asia, reducing the devastating death and disability caused by this disease. In addition to impacting low-income countries, the vaccine will allow countries that purchase vaccine—such as Thailand, Vietnam, Sri Lanka, and India—to recover health care dollars, improve their present programs, and address other unmet health care needs.

  Eligibility

Ages Eligible for Study:   8 Months to 11 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant is healthy, aged between 8 months (± 2 weeks) at inclusion visit
  • Subject is a full-term infant
  • Subject's parents or legal guardian willing to provide signed informed consent.
  • Children have completed 3 doses each of diphtheria, tetanus, pertussis (DTP) and oral polio vaccine (OPV).

Exclusion Criteria:

  • History of documented HIV.
  • Known or suspected impairment of immunologic function.
  • History of serious chronic disease
  • Underlying medical condition such as inborn errors of metabolism, failure to thrive, bronchopulmonary dysplasia, or any major congenital abnormalities requiring surgery or chronic treatment.
  • Acute medical illness with or without fever within the last 72 hours or an axillary temperature ≥ 37.5°C at the time of inclusion.
  • History of documented suspected encephalitis, encephalopathy, or meningitis
  • History of measles
  • History of thrombocytopenic purpura.
  • Received any JE or measles vaccine prior to enrollment.
  • Received any vaccine, other than the study vaccines, within 2 weeks prior to or scheduled to receive a non-study vaccination during the conduct of this trial.
  • Hypotonic - hyporesponsiveness, after the preceding vaccination.
  • History of seizures, including history of febrile seizures, or any other neurologic disorder.
  • 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 the study vaccines. 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 enrollment.
  • Suspected or known hypersensitivity to any of the investigational or marketed vaccine components.
  • Serious adverse event related to the vaccine (i.e., possible, probably, definite)
  • Persistent inconsolable crying (>3 hours) observed after a previous dose.
  • Unable to attend the scheduled visits or comply with the study procedures.
  • Enrolled in another clinical trial involving any therapy.
  • 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: NCT00249769

Locations
Philippines
Research Institute for Tropical Medicine
Manila, Philippines
Sponsors and Collaborators
PATH
Investigators
Principal Investigator: Salvacion Gatchalian, MD Research Institute for Tropical Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00249769     History of Changes
Other Study ID Numbers: JEV01
Study First Received: November 3, 2005
Last Updated: May 5, 2008
Health Authority: Philippines: Bureau of Food and Drugs

Keywords provided by PATH:
Japanese Encephalitis
Japanese B Encephalitis
Japanese B Viral Encephalitis
Viral Encephalitis, Japanese B

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

ClinicalTrials.gov processed this record on September 22, 2014