- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00412516
Determining Long-Term Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles Vaccine
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Manila, Philippines
- Research Institute for Tropical Medicine (RITM)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Group 1
JE live attenuated SA 14-14-2 vaccine then measles vaccine after one month
|
Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)
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Experimental: Group 2
JE live attenuated SA 14-14-2 vaccine and measles vaccine concurrently
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Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)
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Other: Group 3
Measles vaccine then JE live attenuated SA 14-14-2 vaccine after one month
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Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measles Seropositivity at 24 and 36 Months
Time Frame: 24, 36 months post vaccination
|
Seropositivity defined as an anti-MV IgG concentration of 120 mIU/mL determined with the Siemens ELISA
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24, 36 months post vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measles Seropositivity at 12 Months
Time Frame: 12 months post vaccination
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Seropositivity defined as an anti-MV IgG concentration of 120 mIU/mL determined with the Siemens ELISA
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12 months post vaccination
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Seropositive Rate for Japanese Encephalitis (JE) Antibody in Infants in the Philippines Who Received Measles Vaccine (MV) Before, With, or After SA 14-14-2 JE Vaccination by Month After JE Vaccination.
Time Frame: 12 months, 24 months, and 36 months post vaccination
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"Seropositive" defined as a person with neutralizing antibody against JE virus at a titer ≥ 1:10 in a 50% plaque-reduction neutralizing assay (PRNT-50)
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12 months, 24 months, and 36 months post vaccination
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Geometric Mean Neutralizing Antibody Titer to Japanese Encephalitis (JE) Virus in Infants in the Philippines Who Received Measles Vaccine (MV) Before, With, or After SA 14-14-2 JE Vaccination by Month After JE Vaccination.
Time Frame: 12, 24, 36 months post-JE vaccination
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Neutralizing antibody titer determined using a 50% plaque-reduction neutralizing assay (PRNT-50) for JE virus
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12, 24, 36 months post-JE vaccination
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Salvacion Gatchalian, MD, Research Institute for Tropical Medicine (RITM)
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Encephalitis, Arbovirus
- Encephalitis, Viral
- Central Nervous System Viral Diseases
- Central Nervous System Infections
- Infectious Encephalitis
- Arbovirus Infections
- Vector Borne Diseases
- Flavivirus Infections
- Flaviviridae Infections
- Morbillivirus Infections
- Paramyxoviridae Infections
- Mononegavirales Infections
- Encephalitis, Japanese
- Encephalitis
- Measles
Other Study ID Numbers
- JEV02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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