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

This study has been completed.
Sponsor:
Collaborators:
National Institute of Mental Health and Neuro Sciences, India
University of Liverpool
PATH
Wellcome Trust
Information provided by (Responsible Party):
Prof S Vijaya, Dr. Lance Turtle, Indian Institute of Science
ClinicalTrials.gov Identifier:
NCT01656200
First received: July 27, 2012
Last updated: June 10, 2014
Last verified: June 2014

July 27, 2012
June 10, 2014
May 2012
October 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01656200 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Number of participants reporting adverse events (graded in severity 1-4). [ Time Frame: one month ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Prospective, Open Label Study of Human T Cell Responses to Live Attenuated Japanese Encephalitis Vaccine SA14-14-2
A Prospective, Open Label Study of Human T Cell Responses to Live Attenuated Japanese Encephalitis Vaccine SA14-14-2

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Japanese Encephalitis
  • Japanese Encephalitis Vaccine
Biological: Live attenuated Japanese encephalitis vaccine SA14-14-2
Live attenuated Japanese encephalitis vaccine SA14-14-2
Experimental: Vaccine
Single dose live attenuated Japanese encephalitis vaccine SA14-14-2
Intervention: Biological: Live attenuated Japanese encephalitis vaccine SA14-14-2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
March 2014
October 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

  • A male or female adult between 18 and 50 years of age.
  • Written informed consent.
  • Free of obvious health problems as established by medical history and history- directed physical examination before entering the study.
  • Expected continuous residence in India during study period, without travel outside India
  • An efficacious method of contraception must be used during the study for women of childbearing potential.

Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding administration of SA14-14-2 vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within a period of six months before vaccination or at any time during the study period.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition.
  • A family history of congenital or hereditary immunodeficiency.
  • Any antiviral drug therapy within a period of six months before vaccination or at any time during the study period.
  • History of significant allergic disease or reactions likely to be exacerbated by any component of the study vaccine, especially allergic disease or reactions to any previous dose of any vaccine.
  • History of having received JE vaccine, yellow fever vaccine, tick-borne encephalitis vaccine or experimental flavivirus vaccine.
  • History of documented JE infection.
  • Detectable anti JE or West Nile neutralizing antibodies in screening tests.
  • Acute disease at the time of enrollment. Entry into the study may be deferred until the illness is resolved.
  • Acute or chronic, clinically significant, pulmonary, cardiovascular, hepatic, neurological or renal functional abnormality, as determined by history and physical or laboratory examination that is not controlled by drugs.
  • Administration of immunoglobulins and/or any blood products within the three months preceding administration of vaccine, or planned administration during the study period.
  • Seropositive for HIV, HCV or HbsAg.
  • Lactation, pregnancy or intention to get pregnant.
  • History of excessive alcohol consumption, drug abuse or significant psychiatric illness.
  • Any other condition that in the opinion of the investigator would pose a health risk to the participant or interfere with the evaluation of the vaccine.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01656200
JEV SA14-14-2/T cell/01
No
Prof S Vijaya, Dr. Lance Turtle, Indian Institute of Science
Indian Institute of Science
  • National Institute of Mental Health and Neuro Sciences, India
  • University of Liverpool
  • PATH
  • Wellcome Trust
Principal Investigator: Prof S Vijaya, PhD Indian Institute of Science
Principal Investigator: Dr V Ravi, MBBS MD National Institute of Mental Health and Neuro Sciences, India
Indian Institute of Science
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP