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Immunogenicity of a JE-CV as a Booster Dose After a Primary Vaccination With SA14-14-2 Vaccine

Primary Purpose

Japanese Encephalitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
a live attenuated chimeric JE vaccine
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Japanese Encephalitis focused on measuring geometric mean titer, seroprotection, live attenuated chimeric JE vaccine, JE-CV, SA14-14-2 vaccine

Eligibility Criteria

1 Year - 5 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

1 Children aged 1 to <5 years on the day of inclusion

2. History of received 1 dose of SA14-14-2 vaccine 12-24 months prior to enrollment

3. In good general health at the time of inclusion

4. Provision of informed consent by the parent(s) or legal guardian(s)

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    a live attenuated chimeric JE vaccine

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Proportion of children who had seroprotection at day 0 pre-vaccination and day 28 post vaccination
    seroprotection defined as titer ≥10

    Full Information

    First Posted
    October 12, 2015
    Last Updated
    January 17, 2016
    Sponsor
    Chulalongkorn University
    Collaborators
    Sanofi Pasteur, a Sanofi Company
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02602652
    Brief Title
    Immunogenicity of a JE-CV as a Booster Dose After a Primary Vaccination With SA14-14-2 Vaccine
    Official Title
    Immunogenicity of a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) as a Booster Dose After a Primary Vaccination With SA14-14-2 Vaccine in Thai Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2013 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chulalongkorn University
    Collaborators
    Sanofi Pasteur, a Sanofi Company

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Study design: This open label clinical trial in 50 children aged 1-5 years, was conducted at King Chulalongkorn Memorial Hospital in Thailand. The protocol was approved by the Institutional Review Board of Chulalongkorn University, and the study was performed in accordance with Declaration of Helsinki, International Conference on Harmonization Good Clinical Practice, the European Directive 2001/20/EC, and written informed consent was obtained from parents or a legally acceptable representative before enrolment. Vaccines: JE-CV was manufactured by Sanofi Pasteur Biologics Co., USA., and reconstituted using 0.4% sodium chloride diluent for injection; each dose 0.5 ml contained 4.0-5.8 log10 plaque forming units of virus Serology: JE neutralizing antibody levels were assessed using a PRNT50 assay. The final end point neutralization titer is the inverse of the highest serial dilution of serum that can neutralize ≥ 50% of JE challenge virus. Testing was performed at Focus Diagnostics Inc. using JE-CV as a challenge virus. Statistical methods: sample size was calculated based on historical data from JE15 study, at month 24 after first dose of JE-CV, the GMT of JE neutralizing antibody was 39.4 (95% CI 33.7 to 46.0) and increase to 2242 (95% CI 1913, 2628) at day 28 post JE-CV booster dose. On the assumption that children who received SA14-14-2 vaccine and subsequently get one booster dose of JE-CV at 12-24 months later will have GMT of at least 1040, with 80% power and alpha 0.05, data at least 43 children need to be collected. When accounted for 15% of children who might loss to follow-up or cannot get adequate blood sample, 50 children should be enrolled. The per-protocol population will be used for the main immunogenicity analyses. For the main parameters, 95% confidence intervals (CIs) of point estimates will be calculated using the normal approximation for quantitative data and the exact binomial distribution for proportions. The point estimates and their 95% CI of the following will be presented for each group of the Geometric Mean (GM) of neutralizing antibody on D0 and D28 and the percentage of subjects with neutralizing antibody >=10 at D0 and D28

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Japanese Encephalitis
    Keywords
    geometric mean titer, seroprotection, live attenuated chimeric JE vaccine, JE-CV, SA14-14-2 vaccine

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    a live attenuated chimeric JE vaccine
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Biological
    Intervention Name(s)
    a live attenuated chimeric JE vaccine
    Other Intervention Name(s)
    Japanese Encephalitis Chimeric Virus vaccine
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Changing in geometric mean titer of JE neutralizing antibody at day 0 pre-vaccination and day 28 post vaccination.
    Time Frame
    day 0 pre-vaccination and day 28 post vaccination
    Secondary Outcome Measure Information:
    Title
    Proportion of children who had seroprotection at day 0 pre-vaccination and day 28 post vaccination
    Description
    seroprotection defined as titer ≥10
    Time Frame
    day 0 pre-vaccination and day 28 post vaccination
    Other Pre-specified Outcome Measures:
    Title
    JE-CV related adverse reaction
    Description
    Solicited injection site reactions: redness (in proportion of children) swelling (in proportion of children) pain (in proportion of children) Systemic solicited reactions: (measure in proportion of children) Unsolicited adverse reactions (measure in proportion of children)
    Time Frame
    28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 1 Children aged 1 to <5 years on the day of inclusion 2. History of received 1 dose of SA14-14-2 vaccine 12-24 months prior to enrollment 3. In good general health at the time of inclusion 4. Provision of informed consent by the parent(s) or legal guardian(s) Exclusion Criteria: Receipt of blood or blood products in the past 3 months. Acute febrile illness on the day of vaccination.( BT > 38 C)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pakpoom Janewongwirot, md
    Organizational Affiliation
    Chulalongkorn University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22777096
    Citation
    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.
    Results Reference
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    PubMed Identifier
    23442823
    Citation
    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.
    Results Reference
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    PubMed Identifier
    20856164
    Citation
    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.
    Results Reference
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    PubMed Identifier
    21150279
    Citation
    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.
    Results Reference
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    PubMed Identifier
    22043776
    Citation
    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.
    Results Reference
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    PubMed Identifier
    22084515
    Citation
    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.
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    PubMed Identifier
    23965828
    Citation
    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.
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    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.
    Results Reference
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    Immunogenicity of a JE-CV as a Booster Dose After a Primary Vaccination With SA14-14-2 Vaccine

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