Phase 4
N=17
A Prospective, Open Label Study of Human T Cell Responses to Live Attenuated Japanese Encephalitis Vaccine SA14-14-2
Japanese Encephalitis · Japanese Encephalitis Vaccine
Bottom Line
View on ClinicalTrials.gov: NCT01656200 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Change of T Lymphocyte Responses to Live Attenuated JE SA-14-14-2 Vaccine at Week 2. — 34 IFNγ SFC/million PBMC
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Live attenuated Japanese encephalitis vaccine SA14-14-2 (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indian Institute of Science
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of T Lymphocyte Responses to Live Attenuated JE SA-14-14-2 Vaccine at Week 2. |
34 | — |
| SECONDARY Neutralizing Antibody Titres to Live Attenuated JE SA-14-14-2 Vaccine at Week 4 Post Vaccination. |
18.5 | — |
| SECONDARY Number of Participants Reporting Adverse Events (Graded in Severity 1-4). |
3 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01656200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.