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A Prospective, Open Label Study of Human T Cell Responses to Live Attenuated Japanese Encephalitis Vaccine SA14-14-2

NCT01656200 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2019-04-26

Study results available
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Summary

Japanese encephalitis (JE) live attenuated vaccine SA14-14-2 has been in use for more more than 20 years in Asia. JE vaccine SA14-14-2 is licensed in India and has been widely used since 2006. JE vaccines give protection by generating a neutralizing antibody response, but both naturally exposed persons and patients with JE also have T cell responses. Whether JE vaccine SA14-14-2 elicits T cell responses is unknown. This study tests the hypothesis that T cell responses are generated in response to JE SA14-14-2 vaccination. The aim of this study is to characterize T cell responses to JE vaccine SA14-14-2 in healthy people, and to investigate differences in T cell responses between natural exposure, vaccination and disease.

Conditions

  • Japanese Encephalitis
  • Japanese Encephalitis Vaccine

Interventions

BIOLOGICAL

Live attenuated Japanese encephalitis vaccine SA14-14-2

Live attenuated Japanese encephalitis vaccine SA14-14-2

Sponsors & Collaborators

  • National Institute of Mental Health and Neuro Sciences, India

    collaborator OTHER

  • University of Liverpool

    collaborator OTHER

  • PATH

    collaborator OTHER

  • Wellcome Trust

    collaborator OTHER

  • Indian Institute of Science

    lead OTHER_GOV

Principal Investigators

  • Prof S Vijaya, PhD · Indian Institute of Science

  • Dr V Ravi, MBBS MD · National Institute of Mental Health and Neuro Sciences, India

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-10-31
Completion
2014-03-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01656200 on ClinicalTrials.gov