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Rift Valley FeverEarly Phase 1NCT04754776

Safety and Immunogenicity of a Candidate RVFV Vaccine (RVF001)

A Early Phase 1 study testing ChAdOx1 RVF in people with Rift Valley Fever, run by University of Oxford at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Rift Valley Fever
What is being tested?
ChAdOx1 RVF
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited Kingdom
Study dates
11 Jun 2021to 6 Apr 2022
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The volunteer must satisfy all the following criteria to be eligible for the study:
  • 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

Who cannot join

  • The volunteer may not enter the study if any of the following apply:
  • 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
Show all 32Show fewer
  • 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
  • Any main covid-19 symptom within 28 days of enrolment:
  • Fever (subjective or ≥37.8)
  • New continuous cough
  • Loss of sense of smell
  • Loss of sense of taste
  • Clinical suspicion of acute COVID-19 in the 28 days prior to enrolment
  • 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 (eg. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
  • 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
  • Suspected or known injecting drug abuse in the 5 years preceding enrolment
  • Seropositive for hepatitis B surface antigen (HBsAg)
  • Seropositive for hepatitis C virus (antibodies to HCV)
  • Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
  • Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data
  • Inability of the study team to contact the volunteer's GP (or access summary care record, if available) to confirm medical history and safety to participate
  • Prior natural exposure to RVFV as determined by seropositivity for RVFV antigens by ELISA and neutralizing antibody assay (serology will be requested at the discretion of the investigator)
  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • CCVTM, University of Oxford, Churchill Hospital

    Oxford, OX3 7LE

Other trials in United Kingdom

About this study

Official title: A Phase I Study to Determine the Safety & Immunogenicity of the Candidate Rift Valley Fever Virus (RVFV) Vaccine ChAdOx1 RVF in UK Healthy Adult Volunteers

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

Read the detailed description

The purpose of this study is to test a new vaccine against the Rift Valley Fever Virus (RVFV) in healthy volunteers.

Rift Valley fever is a disease caused by RVFV and it is transmitted to humans through a mosquito bite or contact with virus-contaminated tissues and fluids. Although initially restricted to Africa, the virus can be transmitted by several different mosquito species that are more widely distributed than the virus itself, leading to concerns of disease spread as has occurred in the Arabian Peninsula and Madagascar. In humans, RVFV infection usually presents as a sudden febrile illness, but severe manifestations including bleeding disorders and neurological complications may also occur. RVFV is considered a global health threat with significant potential for international spread and use in bioterrorism.

Vaccines against RVFV are available for livestock, however no licensed vaccines or specific treatments are currently available for humans.

The study will enable assessment of the safety of the new vaccine called ChAdOx1 RVF and the extent of immune response in healthy volunteers. Healthy adult volunteers will receive a single dose of a new candidate vaccine at different doses. The objective of this first-in-human study is to find the optimal dose of the vaccine, balancing immune responses and profile of adverse events.

Healthy volunteers aged 18-50 will be recruited in Oxford and vaccinated at the Centre for Clinical Vaccinology and Tropical Medicine and will be followed for a period of 3 months. The study is funded by the UK Biotechnology and Biological Sciences Research Council(BBSRC) and the Medical Research Council (MRC)/Department of Health, through the UK Vaccines Network.

Being tested
ChAdOx1 RVF
Keywords
RVF, ChAdOx1, vaccine
Medical subject headings
Rift Valley Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChAdOx1 RVFBiological

    Single dose of ChAdOx1 RVF

Study groups in NCT04754776
Study groupRoleWhat they receive
Low doseExperimental5 x 10^9 vp ChAdOx1 RVF delivered intramuscularly
Receives: Biological: ChAdOx1 RVF
Medium doseExperimental2.5 x 10^10 vp ChAdOx1 RVF delivered intramuscularly
Receives: Biological: ChAdOx1 RVF
High doseExperimental5 x 10^10 vp ChAdOx1 RVF delivered intramuscularly
Receives: Biological: ChAdOx1 RVF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess local reactogenicity

    Occurrence of solicited local reactogenicity signs and symptoms

    Measured: 7 days following vaccination

  2. To assess systemic reactogenicity

    Occurrence of solicited systemic reactogenicity signs and symptoms

    Measured: 7 days following vaccination

  3. To assess unsolicited adverse events

    Occurrence of unsolicited adverse events

    Measured: 28 days following vaccination

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

    Frequency of participants with clinically significant changes from baseline safety laboratory measures (haematology and biochemistry blood results)

    Measured: Duration of study (6 months)

  5. To assess serious adverse events

    Occurrence of serious adverse events

    Measured: Duration of study (6 months)

Secondary outcomes (3)

  1. Assess the cellular and humoral immunogenicity of ChAdOx1 RVF in healthy adult volunteers

    ELISA to quantify antibodies to GnGc proteins

    Measured: Duration of study (6 months)

  2. Assess the cellular and humoral immunogenicity of ChAdOx1 RVF in healthy adult volunteers

    RVFV neutralising antibody titres

    Measured: Duration of study (6 months)

  3. Assess the cellular and humoral immunogenicity of ChAdOx1 RVF in healthy adult volunteers

    Ex vivo ELISpot and flow cytometry responses to GnGc

    Measured: Duration of study (6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2021
  2. Study start11 Jun 2021
  3. Primary completion6 Apr 2022
  4. Study completion6 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04754776
Sponsor's protocol ID
RVF001
Status last verified
Apr 2022
First submitted
5 Feb 2021
Last updated
19 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jenkin D, Wright D, Folegatti PM, Platt A, Poulton I, Lawrie A, Tran N, Boyd A, Turner C, Gitonga JN, Karanja HK, Mugo D, Ewer KJ, Bowden TA, Gilbert SC, Charleston B, Kaleebu P, Hill AVS, Warimwe GM. Safety and immunogenicity of a ChAdOx1 vaccine against Rift Valley fever in UK adults: an open-label, non-randomised, first-in-human phase 1 clinical trial. Lancet Infect Dis. 2023 Aug;23(8):956-964. doi: 10.1016/S1473-3099(23)00068-3. Epub 2023 Apr 13.

    PubMed 37060917

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing ChAdOx1 RVF in people with Rift Valley Fever, run by University of Oxford at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess local reactogenicity (time frame: 7 days following vaccination). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04754776, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.

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