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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01656200
Recruitment Status : Completed
First Posted : August 2, 2012
Results First Posted : April 26, 2019
Last Update Posted : April 26, 2019
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

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Change of T Lymphocyte Responses to Live Attenuated JE SA-14-14-2 Vaccine at Week 2. [ Time Frame: Week 1, week 2, week 4, week 8, 6 months ]
    Interferon gamma (IFNγ) spot forming cells (SFC)/million peripheral blood mononuclear cells (PBMC) at week 2 (peak response)


Secondary Outcome Measures :
  1. Neutralizing Antibody Titres to Live Attenuated JE SA-14-14-2 Vaccine at Week 4 Post Vaccination. [ Time Frame: 4 weeks ]
    Neutralizing antibody titres (measured by 50% Plaque reduction neutralisation titre (PRNT50)) at 4 weeks post vaccination

  2. Number of Participants Reporting Adverse Events (Graded in Severity 1-4). [ Time Frame: one month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
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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): NCT01656200


Locations
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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
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof S Vijaya, Dr. Lance Turtle, Professor, Indian Institute of Science
ClinicalTrials.gov Identifier: NCT01656200    
Other Study ID Numbers: JEV SA14-14-2/T cell/01
First Posted: August 2, 2012    Key Record Dates
Results First Posted: April 26, 2019
Last Update Posted: April 26, 2019
Last Verified: April 2019
Keywords provided by Prof S Vijaya, Dr. Lance Turtle, Indian Institute of Science:
Japanese encephalitis
Japanese encephalitis vaccine
T lymphocyte
Immune response
Additional relevant MeSH terms:
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Encephalitis, Japanese
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Encephalitis, Viral
Central Nervous System Viral Diseases
Central Nervous System Infections
 Infections
Infectious Encephalitis
Arbovirus Infections
Vector Borne Diseases
Virus Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections