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 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.

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.
✕. Receipt of a recombinant simian adenoviral vaccine prior to enrolment
✕. Planned receipt of another adenoviral vectored vaccine (e.g. Oxford/Astrazeneca or Janssen COVID-19 vaccines) within 90 days after the vaccination with the ChAdOx1 RVF
✕. 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)
✕. COVID-19 infection diagnosed in the community in the 28 days prior to enrolment

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 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.

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.
✕. Receipt of a recombinant simian adenoviral vaccine prior to enrolment
✕. Planned receipt of another adenoviral vectored vaccine (e.g. Oxford/Astrazeneca or Janssen COVID-19 vaccines) within 90 days after the vaccination with the ChAdOx1 RVF
✕. 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)
✕. COVID-19 infection diagnosed in the community in the 28 days prior to enrolment

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)