A Study to Assess the New Candidate Rift Valley Fever Virus Vaccine in Healthy Adults (NCT04672824) | Clinical Trial Compass
CompletedPhase 1
A Study to Assess the New Candidate Rift Valley Fever Virus Vaccine in Healthy Adults
Uganda30 participantsStarted 2022-05-31
Plain-language summary
Randomised, single blind, placebo - controlled, dose-escalation, phase I clinical trial recruiting healthy adults aged 18-50 years
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and female healthy adults aged 18 to 50 years
. Able and willing to provide written informed consent
. Able and willing (in the Investigator's opinion) to comply with all study requirements
. For females only, willingness to practice continuous effective contraception during the study.
. Females of childbearing potential must have a negative urine β-human chorionic gonadotropin (β-hCG) pregnancy test at screening and a negative urine β-hCG pregnancy test immediately prior to study vaccine administration
. Agreement to refrain from blood donation during the course of the study
. Healthy in the investigator's clinical judgement basing on the medical history and physical examination performed at screening
. Healthy on the basis of clinical laboratory tests (within the institutional normal laboratory reference ranges) performed at screening.
Exclusion criteria
. Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assess the safety profile of the candidate vaccine ChAdOx1 RVF in healthy adult volunteers in Uganda: AE
Timeframe: The study duration: 3 months from vaccination
2
Assess the safety profile of the candidate vaccine ChAdOx1 RVF in healthy adult volunteers in Uganda: change in baseline: AE
Timeframe: The study duration: 3 months from vaccination
. Prior receipt of an investigational vaccine as it may impact on interpretation of the trial data.
. 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