Lassa virus Infections and Infestations
Conditions
Interventions
The study's main purpose is to assess the vaccine's safety and the immune response that develops in vaccinated people. The study will recruit up to 31 healthy people aged 18 to 55 years old. Participa
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Participants must satisfy all the following criteria to be eligible for the study: 1. Adults aged between 18 to 55 years (inclusive) at the time of screening. 2. Medically healthy,such that according to investigator judgement,hospitalisation within the study period is not anticipated,and the participant appears likely to be able to remain a study participant through the end of protocol-specified follow-up. Planned elective procedures for pre-existing conditions are allowable. 3. Able to attend the scheduled visits and to comply with all study procedures,including internet access for the recording of electronic diary cards. 4. Willing and able to give informed consent for participation in the study. 5. Willing to allow confirmation of past medical history either through provision of or access to a medical record summary or other medical documentation or allowing investigators to obtain a copy of their medical history from their GP practice or accessed via electronic patient records. 6. Willing to allow their GP and/or consultant,if appropriate,to be notified of participation in the study. 7. Willing to provide their national insurance number or passport number to be registered on The Over-Volunteering Prevention System (TOPS). 8. Agreement to refrain from blood donation during the study. 9. For participants of childbearing potential only (as defined in section 12.10): willing to use effective contraception for the duration of the study AND to have a pregnancy test on the days of screening,vaccination and at the end of the study. The pregnancy tests taken prior to vaccination must be negative.
Exclusion criteria
Exclusion criteria: Participants may not enter the study if any of the following apply: 1. Receipt of an investigational product within 12 weeks prior to enrolment or planned within the trial period. 2. Participation in another research study,in which procedures performed could compromise the integrity of this study (such as significant volumes of blood taken) or are planning to do so within the trial period. 3. History of previous confirmed or suspected Lassa fever or another arenavirus infection. 4. Travel to a Lassa Endemic Country in West Africa within the 12 months prior to enrolment into the study or intended travel to an Endemic Country during the course of the study 5. Administration of immunoglobulins and/or any blood products within three months preceding the planned administration of the vaccine candidate. 6. Any confirmed or suspected immunosuppressive or immunodeficient state,including HIV infection; asplenia; severe infection(s); receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months,or long-term systemic corticosteroid therapy (including for more than 7 consecutive days within three months preceding the planned administration of the vaccine candidate). 7. History of anaphylaxis in relation to vaccination. 8. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including hypersensitivity to the active substance or to any of the excipients of the IMP. 9. History of hereditary angioedema,acquired angioedema,or idiopathic angioedema. 10. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). 11. History of any serious psychiatric condition likely to affect participation in the study. 12. Participants who are pregnant,breastfeeding or lactating,or are planning pregnancy during the study. 13. History of a bleeding disorder (e.g.,Factor deficiency,coagulopathy,or platelet disorder),or prior history of significant bleeding or bruising following IM injections or venepuncture. 14. History of confirmed major thrombotic event (including cerebral venous sinus thrombosis,deep vein thrombosis,pulmonary embolism); history of antiphospholipid syndrome,or history of heparin induced thrombocytopenia. 15. History of capillary leak syndrome. 16. History of Guillian-Barre syndrome,transverse myelitis or other neuroinflammatory syndrome. 17. Moderate,severe and/or uncontrolled cardiovascular disease,respiratory disease,gastrointestinal disease,liver disease,renal disease,haematological,immunological,endocrine disorder,or neurological illness (note,mild well-controlled co-morbidities in a healthy participant are acceptable as judged by the Investigator). 18. Suspected or known current alcohol abuse,as per investigators discretion. 19. Suspected or known injecting drug use within the 5 years preceding enrolment. 20. Acute or chronic hepatitis B or hepatitis C infection. 21. HIV infection. 22. Any clinically significant finding on screening that is either unlikely to resolve or does not resolve (for example on repeat testing at the discretion of an Investigator) within the recruitment timeline of the study. 23. Any other significant disease,disorder or finding which may significantly increase the risk to the volunteer if included in the study,affect the ability of the volunteer to participate in the study,or impair interpretation of the study data. 24. Study site staff or a partner or dependent child of study site staff.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The occurrence of solicited local and systemic reactogenicity signs and symptoms will be monitored and recorded for 7 days following each vaccination. 2. The occurrence of unsolicited adverse events (AEs) will be monitored and recorded for 28 days following each vaccination. 3. The occurrence of abnormal safety laboratory measures will be assessed through laboratory tests for the duration of the study period. 4. The occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs) will be monitored and recorded for the duration of the study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serological response measured using antigen-specific T cell ELISpot assays, ELISA, or other relevant assays before and after vaccination | — |
Countries
England, United Kingdom
Contacts
Public ContactReyna Sara Quintero Barceinas
Outcome results
None listed