Clinical trial NCT02514746: Long-term Immunogenicity After Receipt of JE Vaccine and Antibody Response and Safety to a Booster Dose
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Encephalitis, Japanese
Keywords: Japanese Encephalitis Vaccines
Flavivirus Infections
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: International Centre for Diarrhoeal Disease Research, Bangladesh
First posted: 2015-08-04
Enrollment: 561
Sex: ALL
Minimum age (years): 43
Maximum age (years): 51
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Seroprotection Rate Three and Four Years After Initial Vaccination With CD-JEV
timeFrame: 3 years after initial vaccination (Study Day 1) and 4 years after initial vaccination (Study Day 365)
measure: Geometric Mean Titer of Anti-JE Neutralizing Antibodies Three and Four Years After Initial Vaccination With CD-JEV
timeFrame: 3 years after initial vaccination (Study Day 1) and 4 years after initial vaccination (Study Day 365)
Secondary outcomes:
measure: Seroprotection Rate 7 Days and 28 Days After Booster Dose
timeFrame: 7 days and 28 days following booster vaccination (Study Days 372 and 393)
measure: GMT of Anti-JE Neutralizing Antibodies 7 Days and 28 Days After Booster Dose
timeFrame: 7 days and 28 days following booster vaccination (Study Days 372 and 393)
measure: Seroconversion Rate 7 Days and 28 Days After Booster Dose
timeFrame: 7 days and 28 days following booster vaccination (Study Days 372 and 393)
measure: GMT Ratio of Anti-JE Neutralizing Antibody Titers Between Post-Booster and Pre-Booster Vaccination
timeFrame: 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)
measure: Number of Participants With Immediate Reactions 30 Minutes Following Booster Vaccination
timeFrame: 30 minutes following booster vaccination (Study Day 365)
measure: Number of Participants With Solicited Local Reactions Occurring Within 7 Days of Booster Vaccination
timeFrame: From 30 minutes to 7 days following booster vaccination (Study Day 365 to 372)
measure: Number of Participants With Solicited Systemic Reactions Occurring Within 7 Days of Booster Vaccination
timeFrame: From 30 minutes to 7 days following booster vaccination (Study Day 365 to 372)
measure: Number of Participants With Unsolicited Adverse Events (AEs) and Serious Adverse Events (SAEs) Within 28 Days Following Booster Vaccination
timeFrame: 28 days following booster vaccination (Study Days 365 to 393)
Other outcomes:
Locations:
Study officials:
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: K Zaman, PhD, MPH, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zaman K, Naser AM, Power M, Yaich M, Zhang L, Ginsburg AS, Luby SP, Rahman M, Hills S, Bhardwaj M, Flores J. Lot-to-lot consistency of live attenuated SA 14-14-2 Japanese encephalitis vaccine manufactured in a good manufacturing practice facility and non-inferiority with respect to an earlier product. Vaccine. 2014 Oct 21;32(46):6061-6. doi: 10.1016/j.vaccine.2014.09.012. Epub 2014 Sep 18.
citation: Zaman K, Yunus M, Aziz AB, Feser J, Mooney J, Tang Y, Ellison DW, Thaisomboonsuk B, Zhang L, Neuzil KM, Marfin AA, Letson GW. Antibody persistence and immune memory response following primary vaccination and boosting with live attenuated SA 14-14-2 Japanese encephalitis vaccine (CD-JEV) in Bangladesh: A phase 4 open-label clinical trial. Vaccine X. 2022 Feb 5;10:100143. doi: 10.1016/j.jvacx.2022.100143. eCollection 2022 Apr.