Clinical Trial: A Prospective, Open Label Study of Human T Cell Responses to Live Attenuated Japanese Encephalitis Vaccine SA14-14-2
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Prospective, Open Label Study of Human T Cell Responses to Live Attenuated Japanese Encephalitis Vaccine SA14-14-2
Brief 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.
Detailed Summary:
Sponsor: Indian Institute of Science
Current Primary Outcome: Change in magnitude of T lymphocyte responses to live attenuated JE SA-14-14-2 vaccine over time. [ Time Frame: Week 1, week 2, week 4, week 8, 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in neutralizing antibody titres to live attenuated JE SA-14-14-2 vaccine over time. [ Time Frame: one month, six months and one year after vaccination ]
- Number of participants reporting adverse events (graded in severity 1-4). [ Time Frame: one month ]
Original Secondary Outcome: Same as current
Information By: Indian Institute of Science
Dates:
Date Received: July 27, 2012
Date Started: May 2012
Date Completion:
Last Updated: June 10, 2014
Last Verified: June 2014
