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

Indian Institute of Science

Status and phase

Completed

Phase 4

Conditions

Japanese Encephalitis

Japanese Encephalitis Vaccine

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01656200

JEV SA14-14-2/T cell/01

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.