Determining Long-Term Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles Vaccine
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ClinicalTrials.gov Identifier: NCT00412516 |
Recruitment Status
:
Completed
First Posted
: December 18, 2006
Results First Posted
: October 6, 2014
Last Update Posted
: October 13, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Encephalitis, Japanese B | Biological: Live attenuated SA 14-14-2 vaccine | Phase 3 |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 519 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (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 |
Study Start Date : | December 2006 |
Actual Primary Completion Date : | March 2010 |
Actual Study Completion Date : | March 2010 |
Arm | Intervention/treatment |
---|---|
Group 1
JE live attenuated SA 14-14-2 vaccine then measles vaccine after one month
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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
JE live attenuated SA 14-14-2 vaccine and measles vaccine 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
Measles vaccine then JE live attenuated SA 14-14-2 vaccine after one month
|
Biological: Live attenuated SA 14-14-2 vaccine
Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)
|
- 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
- Measles Seropositivity at 12 Months [ Time Frame: 12 months post vaccination ]Seropositivity defined as an anti-MV IgG concentration of 120 mIU/mL determined with the Siemens ELISA
- 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 ]"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)
- 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 ]Neutralizing antibody titer determined using a 50% plaque-reduction neutralizing assay (PRNT-50) for JE virus

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Ages Eligible for Study: | 20 Months to 36 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00412516
Philippines | |
Research Institute for Tropical Medicine (RITM) | |
Manila, Philippines |
Principal Investigator: | Salvacion Gatchalian, MD | Research Institute for Tropical Medicine (RITM) |
Responsible Party: | PATH |
ClinicalTrials.gov Identifier: | NCT00412516 History of Changes |
Other Study ID Numbers: |
JEV02 |
First Posted: | December 18, 2006 Key Record Dates |
Results First Posted: | October 6, 2014 |
Last Update Posted: | October 13, 2014 |
Last Verified: | October 2014 |
Keywords provided by PATH:
Japanese Encephalitis Japanese B Encephalitis Japanese B Viral Encephalitis Viral Encephalitis, Japanese B |
Additional relevant MeSH terms:
Encephalitis, Japanese Encephalitis Measles Brain Diseases Central Nervous System Diseases Nervous System Diseases Morbillivirus Infections Paramyxoviridae Infections Mononegavirales Infections RNA Virus Infections Virus Diseases |
Encephalitis, Arbovirus Arbovirus Infections Encephalitis, Viral Central Nervous System Viral Diseases Flavivirus Infections Flaviviridae Infections Infectious Encephalitis Central Nervous System Infections Vaccines Immunologic Factors Physiological Effects of Drugs |