Flavivirus Cross-priming Potential of IMOJEV

NCT03920111 | Completed Results

• 1 other identifier: UoL001462 - 4833
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Japanese Encephalitis

Outcome Measures

Primary Outcomes (2)

• Primary: Plasmablast Percentage of Total B Cells at 7 Days Post Vaccine

  Plasmablast percentage of total B cells at 7 days post vaccine Number of plasmablasts sorted by flow cytometry at 7 days post vaccine

  1 week

• Primary: Neutralisation Titre, Measured by 50% of Viral Plaque Reduction at One and Two Months Post Vaccine

  Neutralising antibody titre, measured by 50% of viral plaque reduction at one and two months post vaccine

  two months

Secondary Outcomes (1)

• Secondary: Number of Adverse Events Occurring in All Participants in One Month Post Vaccine

  one month

Study Arms (3)

Group 1 - Any status

OTHER

Up to 3-4 healthy adults

Biological: IMOJEV

Group 2 - FlaviPrime Naive

OTHER

Up to 6-8 healthy adults who have never travelled to a flavivirus endemic area and are negative in screening tests for flavivirus immunity.

Biological: IMOJEV

Group 3 - Flavivirus Exposed

OTHER

Up to 8-10 healthy adults who have had JE vaccine and/or are previously flavivirus exposed, either through receiving yellow fever vaccine up to 5 years before the study, or from being diagnosed with a flavivirus illness (e.g. dengue or Zika).

Biological: IMOJEV

Interventions

IMOJEV BIOLOGICAL

live attenuated Japanese encephalitis (JE) vaccine IMOJEV®

Group 1 - Any status; Group 2 - FlaviPrime Naive; Group 3 - Flavivirus Exposed

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).
• Detectable anti Flavivirus neutralizing antibodies in screening tests (group 2 only).
• Acute disease (for example acute infection) at the time of enrolment or vaccination, if symptoms are rated as anything more significant than a mild adverse event. Entry into the study and/or vaccination may be deferred until the illness has resolved for at least one week.
• Acute or chronic, clinically significant in the opinion of the investigator, disease in any organ system, as determined by history, physical examination or laboratory testing.
• Presence of any inflammatory condition that might require immunomodulatory therapy.
• Current or previous abattoir worker or sheep farmer in Scotland (risk of Louping ill virus exposure; group 2 only).
• 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.

Sponsors & Collaborators

• University of Liverpool: lead

Study Sites (1)

Liverpool University Hospitals NHS Foundation Trust

Liverpool, L7 8XP, United Kingdom

Location

MeSH Terms

Conditions

Encephalitis, Japanese

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Mosquito-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Results Point of Contact

• Title: Dr Lance Turtle
• Organization: University of Liverpool

lance.turtle@liverpool.ac.uk

01517957554

Study Officials

• Lance Turtle, Dr

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Lecturer

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 18, 2019
• Study Start: April 16, 2021
• Primary Completion: December 23, 2021
• Study Completion: May 11, 2022
• Last Updated: January 31, 2025
• Results First Posted: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)