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
  Purpose

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.


Condition Intervention Phase
Japanese Encephalitis
Japanese Encephalitis Vaccine
Biological: Live attenuated Japanese encephalitis vaccine SA14-14-2
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Prospective, Open Label Study of Human T Cell Responses to Live Attenuated Japanese Encephalitis Vaccine SA14-14-2

Resource links provided by NLM:


Further study details as provided by Indian Institute of Science:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 17
Study Start Date: May 2012
Study Completion Date: March 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccine
Single dose live attenuated Japanese encephalitis vaccine SA14-14-2
Biological: Live attenuated Japanese encephalitis vaccine SA14-14-2
Live attenuated Japanese encephalitis vaccine SA14-14-2

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656200

Locations
India
Indian Institute of Science
Bangalore, Karnataka, India, 560 012
National Institute of Mental Health and Neurosciences
Bangalore, Karnataka, India, 560029
Sponsors and Collaborators
Indian Institute of Science
National Institute of Mental Health and Neuro Sciences, India
University of Liverpool
PATH
Wellcome Trust
Investigators
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
  More Information

No publications provided

Responsible Party: Prof S Vijaya, Dr. Lance Turtle, Professor, Indian Institute of Science
ClinicalTrials.gov Identifier: NCT01656200     History of Changes
Other Study ID Numbers: JEV SA14-14-2/T cell/01
Study First Received: July 27, 2012
Last Updated: June 10, 2014
Health Authority: India: Institutional Review Board

Keywords provided by Indian Institute of Science:
Japanese encephalitis
Japanese encephalitis vaccine
T lymphocyte
Immune response

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
Arbovirus Infections
Brain Diseases
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Encephalitis, Arbovirus
Encephalitis, Viral
Flaviviridae Infections
Flavivirus Infections
Nervous System Diseases
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 30, 2014