Immunogenicity of a JE-CV as a Booster Dose After a Primary Vaccination With SA14-14-2 Vaccine
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|ClinicalTrials.gov Identifier: NCT02602652|
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : January 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Japanese Encephalitis||Biological: a live attenuated chimeric JE vaccine||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||December 2013|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Experimental: a live attenuated chimeric JE vaccine
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
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.
Other Name: Japanese Encephalitis Chimeric Virus vaccine
- 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 ]
- Proportion of children who had seroprotection at day 0 pre-vaccination and day 28 post vaccination [ Time Frame: day 0 pre-vaccination and day 28 post vaccination ]seroprotection defined as titer ≥10
- JE-CV related adverse reaction [ Time Frame: 28 days ]
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602652
|Principal Investigator:||Pakpoom Janewongwirot, md||Chulalongkorn University|