- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01656200
A Prospective, Open Label Study of Human T Cell Responses to Live Attenuated Japanese Encephalitis Vaccine SA14-14-2
April 11, 2019 updated by: Prof S Vijaya, Dr. Lance Turtle, Indian Institute of Science
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Karnataka
-
Bangalore, Karnataka, India, 560 012
- Indian Institute of Science
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Bangalore, Karnataka, India, 560029
- National Institute of Mental Health and Neurosciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vaccine
Single dose live attenuated Japanese encephalitis vaccine SA14-14-2
|
Live attenuated Japanese encephalitis vaccine SA14-14-2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Week 1, week 2, week 4, week 8, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
4 weeks
|
Number of Participants Reporting Adverse Events (Graded in Severity 1-4).
Time Frame: one month
|
one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
July 27, 2012
First Submitted That Met QC Criteria
July 31, 2012
First Posted (Estimate)
August 2, 2012
Study Record Updates
Last Update Posted (Actual)
April 26, 2019
Last Update Submitted That Met QC Criteria
April 11, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Encephalitis, Arbovirus
- Encephalitis, Viral
- Central Nervous System Viral Diseases
- Central Nervous System Infections
- Infectious Encephalitis
- Arbovirus Infections
- Vector Borne Diseases
- Flavivirus Infections
- Flaviviridae Infections
- Encephalitis, Japanese
- Encephalitis
Other Study ID Numbers
- JEV SA14-14-2/T cell/01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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