Clinical trial NCT01656200: A Prospective, Open Label Study of Human T Cell Responses to Live Attenuated Japanese Encephalitis Vaccine SA14-14-2
Official title: A Prospective, Open Label Study of Human T Cell Responses to Live Attenuated Japanese Encephalitis Vaccine SA14-14-2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Japanese Encephalitis
Japanese Encephalitis Vaccine
Keywords: Japanese encephalitis
Japanese encephalitis vaccine
T lymphocyte
Immune response
Lead sponsor: Indian Institute of Science
Sponsor class: OTHER_GOV
Collaborators: name: National Institute of Mental Health and Neuro Sciences, India
name: University of Liverpool
name: PATH
name: Wellcome Trust
First posted: 2012-08-02
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: Change of T Lymphocyte Responses to Live Attenuated JE SA-14-14-2 Vaccine at Week 2.
timeFrame: Week 1, week 2, week 4, week 8, 6 months
Secondary outcomes:
measure: Neutralizing Antibody Titres to Live Attenuated JE SA-14-14-2 Vaccine at Week 4 Post Vaccination.
timeFrame: 4 weeks
measure: Number of Participants Reporting Adverse Events (Graded in Severity 1-4).
timeFrame: one month
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Indian Institute of Science
state: Karnataka
city: Bangalore
country: India
facility: National Institute of Mental Health and Neurosciences
state: Karnataka
Study officials:
affiliation: Indian Institute of Science
name: Prof S Vijaya, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Mental Health and Neuro Sciences, India
name: Dr V Ravi, MBBS MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Turtle L, Tatullo F, Bali T, Ravi V, Soni M, Chan S, Chib S, Venkataswamy MM, Fadnis P, Yaich M, Fernandez S, Klenerman P, Satchidanandam V, Solomon T. Cellular Immune Responses to Live Attenuated Japanese Encephalitis (JE) Vaccine SA14-14-2 in Adults in a JE/Dengue Co-Endemic Area. PLoS Negl Trop Dis. 2017 Jan 30;11(1):e0005263. doi: 10.1371/journal.pntd.0005263. eCollection 2017 Jan.