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| Name | Class |
|---|---|
| National Institute of Mental Health and Neuro Sciences, India | OTHER |
| University of Liverpool | OTHER |
| PATH | OTHER |
| Wellcome Trust |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine | Experimental | Single dose live attenuated Japanese encephalitis vaccine SA14-14-2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live attenuated Japanese encephalitis vaccine SA14-14-2 | Biological | Live attenuated Japanese encephalitis vaccine SA14-14-2 |
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| Measure | Description | Time Frame |
|---|---|---|
| Change of T Lymphocyte Responses to Live Attenuated JE SA-14-14-2 Vaccine at Week 2. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Neutralizing Antibody Titres to Live Attenuated JE SA-14-14-2 Vaccine at Week 4 Post Vaccination. | 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). |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof S Vijaya, PhD | Indian Institute of Science | Principal Investigator |
| Dr V Ravi, MBBS MD | National Institute of Mental Health and Neuro Sciences, India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indian Institute of Science | Bangalore | Karnataka | 560 012 | India | ||
| National Institute of Mental Health and Neurosciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28135273 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vaccine | Single dose live attenuated Japanese encephalitis vaccine SA14-14-2 Live attenuated Japanese encephalitis vaccine SA14-14-2: Live attenuated Japanese encephalitis vaccine SA14-14-2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| OTHER |
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| one month |
| Bangalore |
| Karnataka |
| 560029 |
| India |
| COMPLETED |
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| NOT COMPLETED |
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Healthy South Indian Adults resident in Bengaluru, Karnataka State
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| ID | Title | Description |
|---|---|---|
| BG000 | Vaccine | Single dose live attenuated Japanese encephalitis vaccine SA14-14-2 Live attenuated Japanese encephalitis vaccine SA14-14-2: Live attenuated Japanese encephalitis vaccine SA14-14-2 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | Count of participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change of T Lymphocyte Responses to Live Attenuated JE SA-14-14-2 Vaccine at Week 2. | Interferon gamma (IFNγ) spot forming cells (SFC)/million peripheral blood mononuclear cells (PBMC) at week 2 (peak response) | 15 participants had data available at the two week time point. 1 withdrew beforehand, 1 declined to donate thew two week blood sample. | Posted | Geometric Mean | Full Range | IFNγ SFC/million PBMC | Week 1, week 2, week 4, week 8, 6 months |
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| Secondary | Neutralizing Antibody Titres to Live Attenuated JE SA-14-14-2 Vaccine at Week 4 Post Vaccination. | Neutralizing antibody titres (measured by 50% Plaque reduction neutralisation titre (PRNT50)) at 4 weeks post vaccination | 1 participant withdrew before the 4 week time point, for another the sample was not available for analysis. | Posted | Geometric Mean | Full Range | Neutralising antibody titres | 4 weeks |
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| ||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Adverse Events (Graded in Severity 1-4). | Posted | Count of Participants | Participants | one month |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vaccine | Single dose live attenuated Japanese encephalitis vaccine SA14-14-2 Live attenuated Japanese encephalitis vaccine SA14-14-2: Live attenuated Japanese encephalitis vaccine SA14-14-2 | 0 | 17 | 3 | 17 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever, headache, myalgia, sore throat | General disorders | Systematic Assessment |
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| Fever, dry cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Dizziness, Headache | Nervous system disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Dizziness for 2-3 seconds a time | Nervous system disorders | Systematic Assessment |
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| Fever, myalgia | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Lance Turtle | University of Liverpool | +44 151 795 9626 | lance.turtle@liverpool.ac.uk |
| ID | Term |
|---|---|
| D004672 | Encephalitis, Japanese |
| ID | Term |
|---|---|
| D004671 | Encephalitis, Arbovirus |
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D000069544 | Infectious Encephalitis |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D000096724 | Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D012327 | RNA Virus Infections |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D004660 | Encephalitis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
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