Lassa fever Infections and Infestations
Conditions
Interventions
This is a phase I trial to assess the safety, tolerability, and immunogenicity of both a one-dose and two-dose regimen of ChAdOx1 LassaJ in healthy volunteers aged 18-55 years. There will be an initia
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 the investigator's 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 comply with all study procedures 4. Willing and able to give informed consent for participation in the study 5. Able to provide a reliable past medical history confirmed, where necessary, at the investigator’s discretion, by the participant’s usual health care provider 6. Willing to allow the usual health care provider, if appropriate, to be notified of participation in the study. 7. Agreement to refrain from blood donation during the study 8. For participants of childbearing potential only (as defined by protocol section 12.10): willing to use effective contraception for the duration of the study AND to have a pregnancy test on the day of screening and vaccination days. The pregnancy tests taken before 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 before 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 or previous participation in another Lassa vaccine trial. 4. Administration of immunoglobulins and/or any blood products within three months preceding the planned administration of the vaccine candidate. 5. 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). 6. History of anaphylaxis in relation to vaccination. 7. 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. 8. History of hereditary angioedema, acquired angioedema, or idiopathic angioedema. 9. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). 10. History of any serious psychiatric condition likely to affect participation in the study. 11. Participants who are pregnant, breastfeeding or lactating, or are planning pregnancy during the study. 12. 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. 13. 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. 14. History of capillary leak syndrome. 15. History of Guillian-Barre syndrome, transverse myelitis or other neuroinflammatory syndrome. 16. 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). 17. Suspected or known current alcohol abuse, as per investigator's discretion. 18. Suspected or known recreational drug use within the 5 years preceding enrolment. 19. Positive laboratory evidence of acute or chronic hepatitis B or hepatitis C infection. 20. Positive laboratory evidence of HIV infection. 21. 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. 22. 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. 23. Study site staff or a partner, or dependent child of study site staff. 24. Prior history
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measures are assessed using data collected in electronic Case Report Forms (eCRF) at one timepoint: 1.Occurrence of solicited local and systemic reactogenicity signs and symptoms for 28 days following each vaccination 2.Occurrence of unsolicited adverse events (AEs) for 28 days following each vaccination 3.Occurrence of abnormal safety laboratory measures for the duration of the study period 4.Occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs) for the duration of the study period | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of serological response measured using antigen-specific T cell ELISpot assays, ELISA or other relevant assays, before and after vaccination | — |
Countries
Ghana
Contacts
Public ContactMaheshi;Seyram Ramasamy;Kaali
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Outcome results
None listed