A Prospective, Open Label Study of Human T Cell Responses to Live Attenuated Japanese Encephalitis Vaccine SA14-14-2

Phase 4

Completed

• Conditions: Japanese Encephalitis Vaccine; Japanese Encephalitis
• Interventions: Biological: Live attenuated Japanese encephalitis vaccine SA14-14-2

• Registration Number: NCT01656200
• Lead Sponsor: Indian Institute of 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-07-27
• Study First Submitted QC: 2012-07-31
• Study First Posted: 2012-08-02
• Primary Completion: 2013-10
• Study Completion: 2014-03
• Results First Submitted: 2017-08-18
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-11
• Last Update Submitted: 2019-04-11
• Results First Posted: 2019-04-26
• Last Update Posted: 2019-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vaccine	Live attenuated Japanese encephalitis vaccine SA14-14-2	Single dose live attenuated Japanese encephalitis vaccine SA14-14-2

Primary Outcome Measures

Name	Time	Method
Change of T Lymphocyte Responses to Live Attenuated JE SA-14-14-2 Vaccine at Week 2.	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)

Secondary Outcome Measures

Name	Time	Method
Number of Participants Reporting Adverse Events (Graded in Severity 1-4).	one month
Neutralizing Antibody Titres to Live Attenuated JE SA-14-14-2 Vaccine at Week 4 Post Vaccination.	4 weeks	Neutralizing antibody titres (measured by 50% Plaque reduction neutralisation titre (PRNT50)) at 4 weeks post vaccination

Trial Locations

Locations (2)

Indian Institute of Science; 🇮🇳 Bangalore, Karnataka, India

National Institute of Mental Health and Neurosciences; 🇮🇳 Bangalore, Karnataka, India