Clinical trial NCT02602652: 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
Overall status: COMPLETED
Phase: NA
Conditions: Japanese Encephalitis
Keywords: geometric mean titer
seroprotection
live attenuated chimeric JE vaccine
JE-CV
SA14-14-2 vaccine
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Sanofi Pasteur, a Sanofi Company
First posted: 2015-11-11
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

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:

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

Primary outcomes:
measure: Changing in geometric mean titer of JE neutralizing antibody at day 0 pre-vaccination and day 28 post vaccination.
timeFrame: day 0 pre-vaccination and day 28 post vaccination
Secondary outcomes:
measure: Proportion of children who had seroprotection at day 0 pre-vaccination and day 28 post vaccination
timeFrame: day 0 pre-vaccination and day 28 post vaccination
Other outcomes:
measure: JE-CV related adverse reaction
timeFrame: 28 days
Locations:
Study officials:
affiliation: Chulalongkorn University
name: Pakpoom Janewongwirot, md
role: PRINCIPAL_INVESTIGATOR
References:
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