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

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
✕. 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

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

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

NCT IDNCT04672824

SponsorUniversity of Oxford

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-15

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
✕. 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

What they're measuring

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

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