A Prospective, Open Label Study of Human T Cell Responses to Live Attenuated Japanese Encephalitis Vaccine SA14-14-2
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ClinicalTrials.gov Identifier: NCT01656200 |
Recruitment Status
:
Completed
First Posted
: August 2, 2012
Last Update Posted
: June 11, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Japanese Encephalitis Japanese Encephalitis Vaccine | Biological: Live attenuated Japanese encephalitis vaccine SA14-14-2 | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 17 participants |
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 |

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
|
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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
India | |
Indian Institute of Science | |
Bangalore, Karnataka, India, 560 012 | |
National Institute of Mental Health and Neurosciences | |
Bangalore, Karnataka, India, 560029 |
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
First Posted: | August 2, 2012 Key Record Dates |
Last Update Posted: | June 11, 2014 |
Last Verified: | June 2014 |
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:
Encephalitis Encephalitis, Japanese Brain Diseases Central Nervous System Diseases Nervous System Diseases Encephalitis, Arbovirus Arbovirus Infections Virus Diseases Encephalitis, Viral |
Central Nervous System Viral Diseases RNA Virus Infections Flavivirus Infections Flaviviridae Infections Infectious Encephalitis Central Nervous System Infections Vaccines Immunologic Factors Physiological Effects of Drugs |