Japanese EncephalitisPhase 4NCT01656200
A Prospective, Open Label Study of Human T Cell Responses to Live Attenuated Japanese Encephalitis Vaccine SA14-14-2
A Phase 4 study testing Live attenuated Japanese encephalitis vaccine SA14-14-2 in people with Japanese Encephalitis and Japanese Encephalitis Vaccine, run by Indian Institute of Science at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Japanese Encephalitis, Japanese Encephalitis Vaccine
- What is being tested?
- Live attenuated Japanese encephalitis vaccine SA14-14-2
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesIndia
- Study dates
- May 2012to Mar 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
India2 sites
Indian Institute of Science
Bangalore, Karnataka, 560 012
National Institute of Mental Health and Neurosciences
Bangalore, Karnataka, 560029
About this study
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.
- Being tested
- Live attenuated Japanese encephalitis vaccine SA14-14-2
- Keywords
- Japanese encephalitis, Japanese encephalitis vaccine, T lymphocyte, Immune response
- Medical subject headings
- Encephalitis, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live attenuated Japanese encephalitis vaccine SA14-14-2Biological
Live attenuated Japanese encephalitis vaccine SA14-14-2
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Experimental | Single dose live attenuated Japanese encephalitis vaccine SA14-14-2 Receives: Biological: Live attenuated Japanese encephalitis vaccine SA14-14-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Week 1, week 2, week 4, week 8, 6 months
Secondary outcomes (2)
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
Measured: 4 weeks
Number of Participants Reporting Adverse Events (Graded in Severity 1-4).
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Japanese EncephalitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indian Institute of Science
- Sponsor type
- Other government
- Collaborators
- National Institute of Mental Health and Neuro Sciences, India, University of Liverpool, PATH, Wellcome Trust
- Responsible party
- Principal investigator, Prof S Vijaya, Dr. Lance Turtle, Indian Institute of Science
- Investigators
- Prof S Vijaya, PhD, Principal investigator, Indian Institute of ScienceDr V Ravi, MBBS MD, Principal investigator, National Institute of Mental Health and Neuro Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656200
- Sponsor's protocol ID
- JEV SA14-14-2/T cell/01
- Status last verified
- Apr 2019
- First submitted
- 27 Jul 2012
- Last updated
- 26 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 28135273
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label Study of Human T Cell Responses to Live Attenuated Japanese Encephalitis Vaccine SA14-14-2
- ClinicalTrials.gov ID
- NCT01656200
- Acronym / sponsor ID
- JEV SA14-14-2/T cell/01
- Keywords
- Japanese encephalitis, Japanese encephalitis vaccine, T lymphocyte, Immune response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Indian Institute of ScienceOther government
- Collaborators
- National Institute of Mental Health and Neuro Sciences, India, University of Liverpool, PATH, Wellcome Trust
- Study start
- May 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 2 Aug 2012 (estimated)
- Results
- Posted 26 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccine | Experimental | Biological: Live attenuated Japanese encephalitis vaccine SA14-14-2Single dose live attenuated Japanese encephalitis vaccine SA14-14-2 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live attenuated Japanese encephalitis vaccine SA14-14-2Live attenuated Japanese encephalitis vaccine SA14-14-2 | Biological | Vaccine |
Primary outcome
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)
2 secondary outcomes
Neutralizing Antibody Titres to Live Attenuated JE SA-14-14-2 Vaccine at Week 4 Post Vaccination.
Time frame: 4 weeks
Number of Participants Reporting Adverse Events (Graded in Severity 1-4).
Time frame: one month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28135273Turtle 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof S Vijaya, PhD principal investigator
Indian Institute of Science
Dr V Ravi, MBBS MD principal investigator
National Institute of Mental Health and Neuro Sciences, India
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Live attenuated Japanese encephalitis vaccine SA14-14-2 in people with Japanese Encephalitis and Japanese Encephalitis Vaccine, run by Indian Institute of Science at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01656200, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.