Flavivirus Cross-priming Potential of IMOJEV (NCT03920111) | Clinical Trial Compass
CompletedNot Applicable
Flavivirus Cross-priming Potential of IMOJEV
United Kingdom19 participantsStarted 2021-04-16
Plain-language summary
There is a pressing need for a better experimental system to understand flavivirus antibody responses, beyond dengue, to make sure the investigators are using current vaccines to greatest effect and to inform the development of next-generation vaccines. This study will use live chimeric JE vaccine IMOJEV® as a tool for flavivirus epitope discovery. This will allow experimental JEV infection using replication competent, live, attenuated virus as a model, in a setting where the flavivirus infection history of humans can be tightly controlled.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. A male or female adult between 18 and 70 years of age at consent.
✓. Written and informed consent obtained from participant and agreement of participant to comply with the requirements of the study
✓. Able to attend regularly to donate study blood samples for the duration of the study (8 weeks), no planned re-location or travel to a flavivirus endemic area during the study period.
✓. Satisfactory medical screen, as demonstrated by study screening document normal physical examination and normal screening blood tests
✓. Group 1: Any flavivirus exposure status; Group 2: No previous flavivirus vaccination (JE, tick borne encephalitis or yellow fever (YF)), no residence in a flavivirus endemic area nor planned travel to a flavivirus endemic area during the period of the study; Group 3: JE vaccine and/or yellow fever vaccine or other proven flavivirus infection within the last 10 years or other proven flavivirus infection (lifetime).
✓. 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 within 5 half-lives of the drug, or 30 days preceding administration of study JE vaccine, whichever is longer; or planned use during the study period.
✕. Receipt of any investigational biologic agents with mechanisms of action that might affect the immune system, at the discretion of the CI and local PI.
✕. Administration of immunosuppressants or other immune-modifying drugs within a period of six months before vaccination or at any time during the study period; participants who have received these agents may also be excluded at the discretion of the CI and local PI.
What they're measuring
1
Primary: Plasmablast Percentage of Total B Cells at 7 Days Post Vaccine
Timeframe: 1 week
2
Primary: Neutralisation Titre, Measured by 50% of Viral Plaque Reduction at One and Two Months Post Vaccine
✕. Any confirmed or suspected immunosuppressive or immunodeficient condition.
✕. A family history of congenital or hereditary immunodeficiency.
✕. Any antiviral drug therapy within a period of 5 drug half-lives or 30 days before vaccination, whichever is longer, or at any time during the study period.
✕. History of significant allergic 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 (group 2 only).