Lassa Fever
Conditions
Interventions
ChAdOx1 LassaJ
Saline placebo
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 18 to 55 years at the time of screening. 2. Medically healthy according to investigator judgement 3. Willing and able to give informed consent for participation in the study 4. For participants of childbearing potential, 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 prior to vaccination must be negative
Exclusion criteria
Exclusion criteria: eceipt of an investigational product within 12 weeks prior to enrolment or planned within the trial period. 2. History of previous confirmed or suspected Lassa fever or another arenavirus infection or previous participation in another Lassa vaccine trial. 3. Administration of immunoglobulins and/or any blood products within three months preceding the planned administration of the vaccine candidate. 4. Any confirmed or suspected immunosuppressive or immunodeficient state 5. 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. 6. History of hereditary angioedema, acquired angioedema, or idiopathic angioedema. 7. Participants who are pregnant, breastfeeding or lactating, or are planning pregnancy during the study. 8. 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. 9. Prior history of Sensorineural Hearing Loss 10. Hearing loss of 30dB or greater in at least 3 sequential frequencies as determined by pure-tone audiometry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
|---|---|
| Serological responses using antigen specific T cell ELISpot assays, ELISA or other relevant assays, with comparison before and after vaccination | — |
Countries
Ghana
Contacts
Public ContactKwaku Poku Asante
Kintampo Health Research Centre
Outcome results
None listed