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
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
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)
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
NCT ID
NCT02602652
First Posted
October 12, 2015
Last Updated
January 17, 2016
Sponsor
Chulalongkorn University
Collaborators
Sanofi Pasteur, a Sanofi Company
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
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
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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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Citation
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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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