Crimean Congo Haemorrhagic Fever (CCHF) Infections and Infestations
Conditions
Interventions
Following completion of an online questionnaire volunteers will be invited for screening visit, consent and eligibility check. Eligible participants will be assigned to cohort 1 or cohort 2 based on c
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged between 18 to 55 years (inclusive). 2. In good health as determined by: 2.1. Medical history 2.2. Physical examination 2.3. Clinical judgement of the Investigators 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 a GP medical record summary, allowing investigators to obtain a copy of their medical history from their GP practice, or by providing an alternative acceptable means of confirming their past medical history. 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. Agree to refrain from blood donation during the course of the study. 9. For participants of childbearing potential only (as defined by protocol section 8.3): willing to use effective contraception from one month prior to receiving the first dose of vaccine and for the duration of enrolment in the study (and for a minimum of 18 weeks after final study vaccination) AND have a negative high-sensitivity urine pregnancy test on the days of screening and vaccination.
Exclusion criteria
Exclusion criteria: 1. Participation in another research study involving an investigational product, or which includes procedures that could compromise the integrity of this study (such as significant volumes of blood already taken), within the 12 weeks prior to enrollment, or planned participation in such a study within the trial period. 2. History of previous confirmed or suspected CCHF infection. 3. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate. 4. 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 the previous 3 months). 5. History of anaphylaxis in relation to vaccination. 6. 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. 7. History of hereditary angioedema, acquired angioedema, or idiopathic angioedema. 8. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). 9. History of any serious psychiatric condition likely to affect participation in the study. 10. For participants of childbearing potential only: participants who are pregnant, breastfeeding or lactating, or are planning pregnancy during the study. 11. 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. 12. 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. 13. History of episodes of capillary leak syndrome. 14. Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, or neurological illness, as judged by the Investigator (note, mild/moderate well-controlled co-morbidities are acceptable) 15. Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 14 units per week, or an abnormal GGT 16. Suspected or known injecting drug use within the 5 years preceding enrolment. 17. Detectable circulating hepatitis B surface antigen (HBsAg). 18. Seropositive for hepatitis C virus (antibodies to HCV). 19. Seropositive for HIV. 20. Any clinically significant finding on screening investigations, that are either unlikely to resolve or do not resolve on repeat testing (at the discretion of an Investigator) within the recruitment timeline of the study. 21. Member of the study team. This is deliberately loosely defined, but at a minimum will include: anyone on the delegation log; anyone who might be anticipated to be placed onto the delegation log in the course of the study; anyone who has access to personal data on study participants (beyond name, contact details, DOB); and anyone who attends meetings where details of the study are discussed, for example safety updates. Temporary exclusion criteria: 1. Receipt of any systemic corticosteroid (or equivalent) treatment within 14 days prior to vaccination, or for more than 7 days conse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 30/01/2024: 1. Occurrence of solicited local reactogenicity signs and symptoms as recorded in the e-diary, self-reported or investigator observed from D0 to D7 post-vaccination. Timepoints: 7 days following each vaccination (D0 to D7; V2 to V2+7) 2. Occurrence of solicited systemic reactogenicity signs and symptoms as recorded in the e-diary, self-reported or investigator observed from D0 to D7 post-vaccination; Timepoints: 7 days following each vaccination (D0 to D7; V2 to V2+7) 3. Occurrence of unsolicited adverse events (AEs) as recorded in the e-diary, self-reported or investigator observed from D0 to D28 post-vaccination; Timepoints: 28 days following each vaccination (D0 to D28; V2 to V2+28) 4. Occurrence of abnormal safety laboratory measures as recorded and graded in the eCRF by manual entry is specified time periods; Timepoints: Cohort 1: D0, D2, D7, D14, D28, D56, V2, V2+2, V2+7, V2+14, V2+28, V1 + 180, V1+365; Timepoints: Cohort 2: D0, D1, D14, D28, V2, V2+1, V2+14, V2+28, V1+180, V1+365 5. Occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study as recorded in eCRF; Timepoints: Whole duration of the study (D0 to V1 +365) Previous primary outcome measures: 1. Occurrence of solicited local reactogenicity signs and symptoms as recorded in the e-diary, self-reported or investigator observed from D0 to D7 post-vaccination. Timepoints: 7 days following each vaccination (D0 to D7; V2 to V2+7) 2. Occurrence of solicited systemic reactogenicity signs and symptoms as recorded in the e-diary, self-reported or investigator observed from D0 to D7 post-vaccination; Timepoints: 7 days following each vaccination (D0 to D7; V2 to V2+7) 3. Occurrence of unsolicited adverse events (AEs) as recorded in the e-diary, self-reported or investigator observed from D0 to D28 post-vaccination; Timepoints: 28 days following each vaccination (D0 to D28; V2 to V2+28) 4. Occurrence of abnor | — |
Secondary
| Measure | Time frame |
|---|---|
| Anti-CCHF glycoprotein-specific serological response as measured by the laboratory for cohorts 1 and 2 on D0, D28, V2, V2+28 | — |
Countries
United Kingdom
Contacts
Public ContactKavyashri Kashojhala
Outcome results
None listed