NCT02514746

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
561

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2015

Completed
15 days until next milestone

Study Start

First participant enrolled

July 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2016

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2017

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

October 19, 2020

Completed
Last Updated

October 19, 2020

Status Verified

August 1, 2020

Enrollment Period

1.4 years

First QC Date

July 15, 2015

Results QC Date

September 17, 2020

Last Update Submit

September 24, 2020

Conditions

Encephalitis, Japanese

Keywords

Japanese Encephalitis VaccinesFlavivirus Infections

Outcome Measures

Primary Outcomes (2)

  • Seroprotection Rate Three and Four Years After Initial Vaccination With CD-JEV

    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.

    3 years after initial vaccination (Study Day 1) and 4 years after initial vaccination (Study Day 365)

  • Geometric Mean Titer of Anti-JE Neutralizing Antibodies Three and Four Years After Initial Vaccination With CD-JEV

    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.

    3 years after initial vaccination (Study Day 1) and 4 years after initial vaccination (Study Day 365)

Secondary Outcomes (8)

  • Seroprotection Rate 7 Days and 28 Days After Booster Dose

    7 days and 28 days following booster vaccination (Study Days 372 and 393)

  • 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)

  • Seroconversion 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)

  • Number of Participants With Immediate Reactions 30 Minutes Following Booster Vaccination

    30 minutes following booster vaccination (Study Day 365)

  • +3 more secondary outcomes

Study Arms (1)

Live Attenuated JE SA-14-14-2 Vaccine (CD-JEV)

EXPERIMENTAL

Participants previously vaccinated with CD-JEV will receive a booster dose of live, attenuated Japanese encephalitis SA-14-14-2 vaccine four years after initial vaccination.

Biological: Live Attenuated Japanese Encephalitis SA-14-14-2 Vaccine

Interventions

Live Attenuated Japanese Encephalitis SA-14-14-2 VaccineBIOLOGICAL

0.5 mL subcutaneous injection

Also known as: CD-JEV, CD.JEVAX®, RS.JEV®
Live Attenuated JE SA-14-14-2 Vaccine (CD-JEV)

Eligibility Criteria

Age43 Months - 51 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 25239483RESULT

  • 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.

    PMID: 35243320DERIVED

MeSH Terms

Conditions

Encephalitis, JapaneseFlavivirus Infections

Condition Hierarchy (Ancestors)

Encephalitis, ArbovirusEncephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsInfectious EncephalitisArbovirus InfectionsVector Borne DiseasesMosquito-Borne DiseasesVirus DiseasesRNA Virus InfectionsFlaviviridae InfectionsEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory Diseases

Results Point of Contact

Title
Jorge Flores, MD
Organization
PATH
jeflores@path.org
(202) 822-0033

Study Officials

  • K Zaman, PhD, MPH, MBBS

    International Centre for Diarrhoeal Disease Research, Bangladesh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2015

First Posted

August 4, 2015

Study Start

July 30, 2015

Primary Completion

December 15, 2016

Study Completion

January 12, 2017

Last Updated

October 19, 2020

Results First Posted

October 19, 2020

Record last verified: 2020-08