Determining Long-Term 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:
NCT00412516
First received: December 14, 2006
Last updated: June 13, 2011
Last verified: May 2008
  Purpose

The previously conducted JEV01 study looked at the immunogenicity and safety of the concurrent administration of Japanese Live Attenuated SA 14-14-2 and measles vaccines at the one month post vaccination time point. The purpose of the JEV01 study was to help ensure the safety of SA 14-14-2 simultaneously administered with measles vaccine, paving the way for its use in routine EPI programs. As a follow-on to JEV01, this study will enroll those infants who received both vaccines and completed the JEV01 study. This study, however, will provide crucial data to help ensure the long-term immunogenicity of the concurrent administration of these vaccines and provide valuable information to determine the use of these vaccines in routine immunization programs. This study is planned because in the original protocol for JEV01, long-term data points were not included. The hypothesis is that children who receive JE live attenuated SA 14-14-2 vaccine and measles vaccine at the same time have long-term (24 and 36 months post vaccination) protection against these diseases at the same level as those who receive the vaccines at different intervals.


Condition Intervention Phase
Encephalitis, Japanese B
Biological: Live attenuated SA 14-14-2 vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Long-Term Assessment at 24 Months Post-Vaccination of the Non-Inferiority of the Concurrent Administration of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine and Measles Vaccine to Measles Vaccine Given Alone

Resource links provided by NLM:


Further study details as provided by PATH:

Primary Outcome Measures:
  • Seroconversion rates at 36 months post-vaccination for the measles antibody response in infants aged 8-11 months at time of vaccination [ Time Frame: 36 months post vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Seroconversion rates at 12 and 24 months post-vaccination for the measles antibody response; [ Time Frame: 12 and 24 months post vaccination ] [ Designated as safety issue: No ]
  • Seroconversion rates at 12, 24, and 36 months post-vaccination for JE; Evaluation of the long-term (12, 24, and 36 months post-vaccination) safety profiles of the concurrent administration of JE live attenuated SA 14-14-2 and measles vaccine. [ Time Frame: 12, 24, and 26 months post vaccination ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: December 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1
Measles vaccine and and then JE vaccine one month later
Biological: Live attenuated SA 14-14-2 vaccine
Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)
Experimental: Group 2
Measles and JE Vaccine given concurrently
Biological: Live attenuated SA 14-14-2 vaccine
Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)
Group 3
JE and then Measles vaccine one month later
Biological: Live attenuated SA 14-14-2 vaccine
Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)

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 trial is designed to determine the potential interference between the measles vaccine and the Japanese encephalitis vaccine at 12, 24, and 36 months post-vaccination. As these vaccines will be used in routine EPI systems at the same time, similar to how measles and yellow fever vaccine (also a Flavivirus) are administered, it is imperative to collect long-term data showing that neither vaccine interferes with seroconversion of the other when co-administered.This information will help to ensure subject safety and facilitate programmatic efficiency, reducing the number of immunization visits for both parents and health care workers.

  Eligibility

Ages Eligible for Study:   20 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant was enrolled in the JEV01 study previously conducted at RITM.
  • Participant completed his/her vaccination schedule for the JEV01 study previously conducted at RITM.
  • Participant's blood test results from JEV01 study indicate that he/she had seroconverted to measles vaccination.
  • Participant's parents or legal guardian are/is willing to provide signed informed consent.

Exclusion Criteria:

  • Participant was withdrawn from the JEV01 study for any reason.
  • Receipt of immune globulin or other blood products within 6 months of study (JEV02) entry or receipt of injected or oral corticosteroids or other immune modulator therapy (except routine vaccines) within 4 weeks of study (JEV02) entry.
  • Any condition that in the opinion of the investigator, would 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: NCT00412516

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

No publications provided

Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT00412516     History of Changes
Other Study ID Numbers: JEV02
Study First Received: December 14, 2006
Last Updated: June 13, 2011
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, Japanese
Encephalitis
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Brain Diseases

ClinicalTrials.gov processed this record on September 16, 2014