Phase 4
N=561
Long-term Immunogenicity After Receipt of JE Vaccine and Antibody Response and Safety to a Booster Dose
Encephalitis, Japanese
Bottom Line
View on ClinicalTrials.gov: NCT02514746 ↗Enrolled (actual)
561
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Seroprotection Rate Three and Four Years After Initial Vaccination With CD-JEV — 9.2; 9.8; 9.3; 12.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Live Attenuated Japanese Encephalitis SA-14-14-2 Vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- PATH
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seroprotection Rate Three and Four Years After Initial Vaccination With CD-JEV |
9.2; 9.8; 9.3; 12.5; 11.9; 12.4 | — |
| PRIMARY Geometric Mean Titer of Anti-JE Neutralizing Antibodies Three and Four Years After Initial Vaccination With CD-JEV |
5.8; 5.8; 5.8; 6.1; 6.0; 6.1 | — |
| SECONDARY Seroprotection Rate 7 Days and 28 Days After Booster Dose |
90.6; 94.4; 91.4; 97.8; 99.1; 98.1 | — |
| SECONDARY GMT of Anti-JE Neutralizing Antibodies 7 Days and 28 Days After Booster Dose |
98.8; 135.4; 105.4; 156.2; 215.4; 167.0 | — |
| SECONDARY Seroconversion Rate 7 Days and 28 Days After Booster Dose |
88.7; 91.6; 89.3; 96.4; 98.2; 96.8 | — |
| SECONDARY GMT Ratio of Anti-JE Neutralizing Antibody Titers Between Post-Booster and Pre-Booster Vaccination |
16.2; 22.5; 17.3; 25.9; 35.9; 27.7 | — |
| SECONDARY Number of Participants With Immediate Reactions 30 Minutes Following Booster Vaccination |
3; 1; 4; 1; 0; 1 | — |
| SECONDARY Number of Participants With Solicited Local Reactions Occurring Within 7 Days of Booster Vaccination |
1; 1; 2; 0; 0; 0 | — |
| SECONDARY Number of Participants With Solicited Systemic Reactions Occurring Within 7 Days of Booster Vaccination |
14; 5; 19; 10; 3; 13 | — |
| SECONDARY Number of Participants With Unsolicited Adverse Events (AEs) and Serious Adverse Events (SAEs) Within 28 Days Following Booster Vaccination |
57; 26; 83; 48; 22; 70 | — |
Summary
This study aims to understand the persistence of the Japanese encephalitis (JE) antibody response in previously vaccinated children. The proposed study will enrol Bangladeshi children who had previously participated in a lot to lot consistency study (JEV05; NCT01567865) of JE live attenuated SA 14-14-2 vaccine (CD-JEV).
Eligibility Criteria
Inclusion Criteria
- Participant in JEV05 study (NCT01567865) and received one dose of CD-JEV.
- Resides in the Matlab or Mirpur study area.
- At least one parent or guardian willing to provide written informed consent.
Exclusion Criteria
- Received a second dose of Japanese encephalitis vaccine within the past three years.
- Received immunoglobulins and/or any blood products within 90 days prior to enrollment.
- Been diagnosed with a primary or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection within the past three years.
Data sourced from ClinicalTrials.gov (NCT02514746). 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.