Live Attenuated Japanese Encephalitis (JE) Vaccine Coadministered With Measles Vaccine in Infants 9 Months of Age (JEV03)

Study Description

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Brief Summary:

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.

Data from a previous trial, also sponsored by PATH and conducted by investigators in the Philippines, indicate that there was no immunologic interference between Japanese encephalitis live attenuated SA 14-14-2 vaccine and measles vaccine when administered at the same time. Additionally, the safety profile of the coadministered vaccines was the same as for the vaccines administered separately. This research study, to be conducted among infants in Sri Lanka, is being done to confirm the Philippines trial results.

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	277 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (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
Study Start Date :	July 2007
Actual Primary Completion Date :	October 2008
Actual Study Completion Date :	April 2009

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. The proportion of subjects with demonstrated seropositivity for JE and measles at 28 days post coimmunization with live attenuated JE vaccine and measles vaccine.

Secondary Outcome Measures :

1. Geometric mean titer (GMT) of serum antibody to JE among subjects at 28 days post coimmunization with live attenuated JE vaccine and measles vaccine
2. geometric mean titer (GMT) of serum antibody to measles among subjects at 28 days post coimmunization with live attenuated JE and measles vaccine
3. proportion of subjects with immediate reactions (within 30 minutes after injection, with emphasis on allergic reactions)
4. proportion of subjects with local and systemic reactions (including unsolicited events) measured during the first 7 days following vaccination
5. proportion of subjects with adverse events (AEs) (related or unrelated to vaccination) occurring from Day 8 to Day 28
6. serious adverse events (SAEs) (related or unrelated to vaccination) occurring from Day 0 to Day 365
7. the proportion of subjects with demonstrated seropositivity for JE and measles at 365 days post coimmunization with live attenuated JE vaccine and measles vaccine
8. geometric mean titer (GMT) of serum antibody to JE among subjects at 365 days post coimmunization with live attenuated JE vaccine and measles vaccine
9. geometric mean titer (GMT) of serum antibody to measles among subjects at 365 days post coimmunization with live attenuated JE and measles vaccine

Eligibility Criteria

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Ages Eligible for Study:	9 Months to 9 Months (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Healthy child 9 months (±2 weeks) 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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00463684 History of Changes
Other Study ID Numbers:	JEV03; HS382; EC/06/111
First Posted:	April 20, 2007
Last Update Posted:	May 6, 2009
Last Verified:	April 2009

Additional relevant MeSH terms:

Encephalitis; Encephalitis, Japanese; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Encephalitis, Arbovirus; Arbovirus Infections; Virus Diseases; Encephalitis, Viral	Central Nervous System Viral Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Infectious Encephalitis; Central Nervous System Infections; Vaccines; Immunologic Factors; Physiological Effects of Drugs