NCT02602652

Brief Summary

The objective of this study is to measured the Geometric mean titer (GMT) of Japanese Encephalitis neutralizing antibody and proportion of seroprotection among the children who received a booster dose of JE-CV after the first dose of SA14-14-2 vaccine.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2013

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

Study Start

First participant enrolled

December 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
Last Updated

January 20, 2016

Status Verified

January 1, 2016

Enrollment Period

1.6 years

First QC Date

October 12, 2015

Last Update Submit

January 17, 2016

Conditions

Japanese Encephalitis

Keywords

geometric mean titerseroprotectionlive attenuated chimeric JE vaccineJE-CVSA14-14-2 vaccine

Outcome Measures

Primary Outcomes (1)

  • Changing in geometric mean titer of JE neutralizing antibody at day 0 pre-vaccination and day 28 post vaccination.

    day 0 pre-vaccination and day 28 post vaccination

Secondary Outcomes (1)

  • Proportion of children who had seroprotection at day 0 pre-vaccination and day 28 post vaccination

    day 0 pre-vaccination and day 28 post vaccination

Other Outcomes (1)

  • JE-CV related adverse reaction

    28 days

Study Arms (1)

a live attenuated chimeric JE vaccine

EXPERIMENTAL

Children were received JE-CV as a booster dose after vaccinated with SA14-14-2 vaccine as a first dose regimen 12-24 months before.

Biological: a live attenuated chimeric JE vaccine

Interventions

a live attenuated chimeric JE vaccineBIOLOGICAL

The study included 2 visits (D0 and D28). At the first visit (D0), children were enrolled, collected the blood sample for evaluate the baseline immune status and given a JE-CV as a booster dose. After vaccination, children were observed for 30 minutes to monitor any immediate adverse events. Parents were given a digital thermometer for axillary temperature measurement, a ruler for measuring injection site reactions and a diary card for recording a solicited injection site and systemic reactions. At the second visit (D28), blood samples were collected for evaluate the immunogenicity.

Also known as: Japanese Encephalitis Chimeric Virus vaccine
a live attenuated chimeric JE vaccine

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \. History of received 1 dose of SA14-14-2 vaccine 12-24 months prior to enrollment
  • \. Provision of informed consent by the parent(s) or legal guardian(s)

You may not qualify if:

  • Receipt of blood or blood products in the past 3 months.
  • Acute febrile illness on the day of vaccination.( BT \> 38 C)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Feroldi E, Pancharoen C, Kosalaraksa P, Watanaveeradej V, Phirangkul K, Capeding MR, Boaz M, Gailhardou S, Bouckenooghe A. Single-dose, live-attenuated Japanese encephalitis vaccine in children aged 12-18 months: randomized, controlled phase 3 immunogenicity and safety trial. Hum Vaccin Immunother. 2012 Jul;8(7):929-37. doi: 10.4161/hv.20071. Epub 2012 Jul 1.

    PMID: 22777096BACKGROUND

  • Feroldi E, Capeding MR, Boaz M, Gailhardou S, Meric C, Bouckenooghe A. Memory immune response and safety of a booster dose of Japanese encephalitis chimeric virus vaccine (JE-CV) in JE-CV-primed children. Hum Vaccin Immunother. 2013 Apr;9(4):889-97. doi: 10.4161/hv.23087. Epub 2013 Feb 26.

    PMID: 23442823BACKGROUND

  • Chokephaibulkit K, Sirivichayakul C, Thisyakorn U, Sabchareon A, Pancharoen C, Bouckenooghe A, Gailhardou S, Boaz M, Feroldi E. Safety and immunogenicity of a single administration of live-attenuated Japanese encephalitis vaccine in previously primed 2- to 5-year-olds and naive 12- to 24-month-olds: multicenter randomized controlled trial. Pediatr Infect Dis J. 2010 Dec;29(12):1111-7. doi: 10.1097/INF.0b013e3181f68e9c.

    PMID: 20856164BACKGROUND

  • Nasveld PE, Ebringer A, Elmes N, Bennett S, Yoksan S, Aaskov J, McCarthy K, Kanesa-thasan N, Meric C, Reid M. Long term immunity to live attenuated Japanese encephalitis chimeric virus vaccine: randomized, double-blind, 5-year phase II study in healthy adults. Hum Vaccin. 2010 Dec;6(12):1038-46. doi: 10.4161/hv.6.12.13057. Epub 2010 Dec 1.

    PMID: 21150279BACKGROUND

  • Chotpitayasunondh T, Sohn YM, Yoksan S, Min J, Ohrr H. Immunizing children aged 9 to 15 months with live attenuated SA14-14-2 Japanese encephalitis vaccine in Thailand. J Med Assoc Thai. 2011 Aug;94 Suppl 3:S195-203.

    PMID: 22043776BACKGROUND

  • Campbell GL, Hills SL, Fischer M, Jacobson JA, Hoke CH, Hombach JM, Marfin AA, Solomon T, Tsai TF, Tsu VD, Ginsburg AS. Estimated global incidence of Japanese encephalitis: a systematic review. Bull World Health Organ. 2011 Oct 1;89(10):766-74, 774A-774E. doi: 10.2471/BLT.10.085233. Epub 2011 Aug 3.

    PMID: 22084515BACKGROUND

  • Centers for Disease Control and Prevention (CDC). Japanese encephalitis surveillance and immunization--Asia and the Western Pacific, 2012. MMWR Morb Mortal Wkly Rep. 2013 Aug 23;62(33):658-62.

    PMID: 23965828BACKGROUND

  • Janewongwirot P, Puthanakit T, Anugulruengkitt S, Jantarabenjakul W, Phasomsap C, Chumket S, Yoksan S, Pancharoen C. Immunogenicity of a Japanese encephalitis chimeric virus vaccine as a booster dose after primary vaccination with SA14-14-2 vaccine in Thai children. Vaccine. 2016 Oct 17;34(44):5279-5283. doi: 10.1016/j.vaccine.2016.09.005. Epub 2016 Sep 12.

    PMID: 27628323DERIVED

MeSH Terms

Conditions

Encephalitis, Japanese

Condition Hierarchy (Ancestors)

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

Study Officials

  • Pakpoom Janewongwirot, md

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2015

First Posted

November 11, 2015

Study Start

December 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

January 20, 2016

Record last verified: 2016-01