Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT06799234
Eligibility Criteria:
Inclusion Criteria:
* Healthy adult aged 18-50 years
* For females only, willingness to practice continuous effective contraception up to one month following the second vaccination (i.e. duration of 4 months starting from enrolment) and a negative pregnancy test on the day(s) of screening. Effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly, in accordance with the product label. Examples of these include combined oral contraceptives, injectable progestogen, implants of etenogestrel or levonorgestrel, intrauterine device. Female participants will be asked for written confirmation of any family planning methods used by provision of health records. These records will be reviewed and counselling for adherence done at each study visit as per the protocol schedule of attendances. Participants who do not have adequate methods of contraception will be referred to their local dispensary where this will be dispensed for free or to Kilifi County Hospital (KCH). Costs incurred for obtaining contraception at KCH will be covered by the study.
* Agreement to refrain from blood donation during the course of the study
* Able and willing to provide written informed consent
* Plan to remain resident in the study area for 18 months following vaccination
Exclusion Criteria:
* Prior receipt of any vaccines (licensed or investigational) ≤30 days before enrolment and/or planned receipt of a vaccine ≤30 days after enrolment
* Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
* Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
* Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
* Any history of anaphylaxis in relation to vaccination
* Pregnancy, lactation or willingness/intention to become pregnant during the study
* History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
* History of serious psychiatric condition likely to affect participation in the study
* Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture
* Any other serious chronic illness requiring hospital specialist supervision
* Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week (e.g., more than 2 bottles of 500mls Tusker (beer) a day, more than 2 large glasses of 12% wine per day)
* Suspected or known injecting drug abuse in the 5 years preceding enrolment
* Seropositive for hepatitis B surface antigen (HBsAg)
* Seropositive for hepatitis C virus (HCV)
* Prior natural exposure to RVFV as determined by seropositivity for RVFV antigens by ELISA
* Any clinically significant abnormal finding on screening biochemistry, hematology or coagulation blood tests or urinalysis
* Any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the risk to the participant because of participation in the study, affect the ability of the individual to participate in the study or impair interpretation of the study data
* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT06799234
Study Brief:
Protocol Section:
NCT06799234