NCT01656200

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 2, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

April 26, 2019

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

1.4 years

First QC Date

July 27, 2012

Results QC Date

August 18, 2017

Last Update Submit

April 11, 2019

Conditions

Japanese EncephalitisJapanese Encephalitis Vaccine

Keywords

Japanese encephalitisJapanese encephalitis vaccineT lymphocyteImmune response

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Neutralizing Antibody Titres to Live Attenuated JE SA-14-14-2 Vaccine at Week 4 Post Vaccination.

    4 weeks

  • Number of Participants Reporting Adverse Events (Graded in Severity 1-4).

    one month

Study Arms (1)

Vaccine

EXPERIMENTAL

Single dose live attenuated Japanese encephalitis vaccine SA14-14-2

Biological: Live attenuated Japanese encephalitis vaccine SA14-14-2

Interventions

Live attenuated Japanese encephalitis vaccine SA14-14-2BIOLOGICAL

Live attenuated Japanese encephalitis vaccine SA14-14-2

Vaccine

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Indian Institute of Science

Bangalore, Karnataka, 560 012, India

Location

National Institute of Mental Health and Neurosciences

Bangalore, Karnataka, 560029, India

Location

Related Publications (1)

  • 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.

    PMID: 28135273DERIVED

MeSH Terms

Conditions

Encephalitis, Japanese

Condition Hierarchy (Ancestors)

Encephalitis, ArbovirusEncephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsInfectious EncephalitisArbovirus InfectionsVector Borne DiseasesMosquito-Borne DiseasesVirus DiseasesRNA Virus InfectionsFlavivirus InfectionsFlaviviridae InfectionsEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory Diseases

Results Point of Contact

Title
Dr Lance Turtle
Organization
University of Liverpool
lance.turtle@liverpool.ac.uk
+44 151 795 9626

Study Officials

  • 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

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 27, 2012

First Posted

August 2, 2012

Study Start

May 1, 2012

Primary Completion

October 1, 2013

Study Completion

March 1, 2014

Last Updated

April 26, 2019

Results First Posted

April 26, 2019

Record last verified: 2019-04

Locations

IN(2)