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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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ClinicalTrials.gov Identifier: NCT02602652
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : January 20, 2016
Sponsor:
Collaborator:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Chulalongkorn University

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.

Condition or disease Intervention/treatment Phase
Japanese Encephalitis Biological: a live attenuated chimeric JE vaccine Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 Measures :
  1. 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


Other Outcome Measures:
  1. 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)




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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

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


Sponsors and Collaborators
Chulalongkorn University
Sanofi Pasteur, a Sanofi Company
Investigators
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Principal Investigator: Pakpoom Janewongwirot, md Chulalongkorn University

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT02602652     History of Changes
Other Study ID Numbers: IRB456/56
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016

Keywords provided by Chulalongkorn University:
geometric mean titer
seroprotection
live attenuated chimeric JE vaccine
JE-CV
SA14-14-2 vaccine

Additional relevant MeSH terms:
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Encephalitis, Japanese
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs