Phase 4
N=305
Boosterability of Live Attenuated Japanese Encephalitis (JE) Vaccine in Children Who Have Previously Received Inactivated JE Vaccine
Japanese Encephalitis
Bottom Line
View on ClinicalTrials.gov: NCT00463476 ↗Enrolled (actual)
305
Serious AEs
9.8%
Results posted
Mar 2020
Primary outcome: Primary: Percentage of Participants With Demonstrated Seropositivity for Japanese Encephalitis (JE) Neutralizing Antibodies — 98.0; 99.3; 100.0; 100.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (LJEV) (Biological)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- PATH
- Primary completion
- Nov 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Demonstrated Seropositivity for Japanese Encephalitis (JE) Neutralizing Antibodies |
98.0; 99.3; 100.0; 100.0; 100.0; 99.3 | — |
| SECONDARY Geometric Mean Titer (GMT) of Japanese Encephalitis (JE) Neutralizing Antibodies |
697; 926; 3175; 2776; 3170; 2585 | — |
| SECONDARY Number of Participants With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE) |
0; 1; 31; 46; 1; 6 | — |
| SECONDARY Number of Participants Experiencing Solicited Local Reactions Up to 3 Days Post-vaccination |
31; 46; 27; 41; 4; 5 | — |
| SECONDARY Number of Participants Experiencing Solicited Systemic Reactions up to 7 Days Post-vaccination |
44; 38; 1; 1; 12; 16 | — |
Summary
To facilitate introduction of live attenuated SA 14-14-2 Japanese encephalitis vaccine (LJEV) into the National Immunization Programme of Sri Lanka, we evaluated the safety and immunogenicity of co-administration of LJEV and measles vaccine in children at 2 and 5 years of age. The primary hypothesis was that the seropositivity rate at 28 days post vaccination of SA 14-14-2 in subjects 2 and 5 years of age who have already received at least two doses of mouse brain-derived inactivated JE vaccine is greater than 80%.
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.
Eligibility Criteria
Inclusion Criteria
- Healthy child 2 years (±3 months) or 5 years (±3 months) 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 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.
Data sourced from ClinicalTrials.gov (NCT00463476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.