CompletedEarly Phase 1

Safety and Immunogenicity of a Candidate RVFV Vaccine (RVF001)

United Kingdom15 participantsStarted 2021-06-11

Plain-language summary

Phase I open label, non-randomised dose escalation study on healthy UK volunteers aged from 18 to 50 years to assess the safety and immunogenicity of ChAdOx1 RVF

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

. Healthy adults aged 18 to 50 years
. Able and willing (in the Investigator's opinion) to comply with all study requirements
. Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner or access this medical history electronically
. For females only, willingness to practice continuous effective contraception for at least 3 months and a negative pregnancy test on the day(s) of screening and vaccination
. Agreement to refrain from blood donation during the course of the study
. Able to provide written informed consent

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
. Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data.
. Prior receipt of any vaccines administered ≤30 days before enrolment and/or planned receipt of a vaccine ≤30 days after enrolment EXCEPT for protein, RNA (or other non-adenovirus based) COVID-19 vaccinations which may be given within 14 days of the trial vaccine.

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

To assess local reactogenicity

Timeframe: 7 days following vaccination

To assess systemic reactogenicity

Timeframe: 7 days following vaccination

To assess unsolicited adverse events

Timeframe: 28 days following vaccination

To assess the safety and tolerability of ChAdOx1 RVF in healthy adult volunteers

Timeframe: Duration of study (6 months)

To assess serious adverse events

Timeframe: Duration of study (6 months)

Trial details

NCT IDNCT04754776

SponsorUniversity of Oxford

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-06

View on ClinicalTrials.gov More Rift Valley Fever trials

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

. Healthy adults aged 18 to 50 years
. Able and willing (in the Investigator's opinion) to comply with all study requirements
. Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner or access this medical history electronically
. For females only, willingness to practice continuous effective contraception for at least 3 months and a negative pregnancy test on the day(s) of screening and vaccination
. Agreement to refrain from blood donation during the course of the study
. Able to provide written informed consent

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
. Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data.
. Prior receipt of any vaccines administered ≤30 days before enrolment and/or planned receipt of a vaccine ≤30 days after enrolment EXCEPT for protein, RNA (or other non-adenovirus based) COVID-19 vaccinations which may be given within 14 days of the trial vaccine.

What they're measuring

To assess local reactogenicity

Timeframe: 7 days following vaccination

To assess systemic reactogenicity

Timeframe: 7 days following vaccination

To assess unsolicited adverse events

Timeframe: 28 days following vaccination

To assess the safety and tolerability of ChAdOx1 RVF in healthy adult volunteers

Timeframe: Duration of study (6 months)

To assess serious adverse events

Timeframe: Duration of study (6 months)