Assessment of Long Term Immunogenicity of Japanese Encephalitis Live Attenuated SA-14-14-2 Vaccine in Previously Vaccinated Bangladeshi Children and Antibody Response and Safety to a Booster Dose
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Encephalitis, Japanese
- Sponsor
- PATH
- Enrollment
- 561
- Primary Endpoint
- Geometric Mean Titer of Anti-JE Neutralizing Antibodies Three and Four Years After Initial Vaccination With CD-JEV
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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).
Detailed Description
Study participants previously immunized with CD-JEV (Clinical Trials identifier: NCT01567865, JEV05) will have serum collected three and four years after initial vaccination to assess long-term immunogenicity. Four years after receiving the initial dose of CD-JEV, eligible participants will be vaccinated with a second subcutaneous dose of CD-JEV to assess the antibody response. Participants will be monitored for safety for 28 days following receipt of the booster dose.
Investigators
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.
Outcomes
Primary Outcomes
Geometric Mean Titer of Anti-JE Neutralizing Antibodies Three and Four Years After Initial Vaccination With CD-JEV
Time Frame: 3 years after initial vaccination (Study Day 1) and 4 years after initial vaccination (Study Day 365)
The geometric mean titer (GMT) of anti-JE neutralizing antibodies 3 and 4 years after initial vaccination with CD-JEV in Study JEV05 and prior to receiving the booster vaccination in the current study, measured using PRNT-50.
Seroprotection Rate Three and Four Years After Initial Vaccination With CD-JEV
Time Frame: 3 years after initial vaccination (Study Day 1) and 4 years after initial vaccination (Study Day 365)
Seroprotection rate is defined as the percentage of participants with an anti-Japanese encephalitis (JE) neutralizing antibody titer ≥ 1:10 as measured using a 50% plaque reduction neutralization test (PRNT-50). Seroprotection was assessed at 3 and 4 years after the initial vaccination in Study JEV05, prior to participants receiving a booster vaccination in the current study.
Secondary Outcomes
- GMT of Anti-JE Neutralizing Antibodies 7 Days and 28 Days After Booster Dose(7 days and 28 days following booster vaccination (Study Days 372 and 393))
- Number of Participants With Solicited Systemic Reactions Occurring Within 7 Days of Booster Vaccination(From 30 minutes to 7 days following booster vaccination (Study Day 365 to 372))
- Seroprotection Rate 7 Days and 28 Days After Booster Dose(7 days and 28 days following booster vaccination (Study Days 372 and 393))
- GMT Ratio of Anti-JE Neutralizing Antibody Titers Between Post-Booster and Pre-Booster Vaccination(4 years after the initial vaccination (Study Day 365, pre-booster vaccination) and 7 and 28 days following booster vaccination (Study Days 372 and 393))
- Seroconversion Rate 7 Days and 28 Days After Booster Dose(7 days and 28 days following booster vaccination (Study Days 372 and 393))
- Number of Participants With Solicited Local Reactions Occurring Within 7 Days of Booster Vaccination(From 30 minutes to 7 days following booster vaccination (Study Day 365 to 372))
- Number of Participants With Unsolicited Adverse Events (AEs) and Serious Adverse Events (SAEs) Within 28 Days Following Booster Vaccination(28 days following booster vaccination (Study Days 365 to 393))
- Number of Participants With Immediate Reactions 30 Minutes Following Booster Vaccination(30 minutes following booster vaccination (Study Day 365))