AzTrials
AzTrials

RVFPhase 1NCT04672824

A Study to Assess the New Candidate Rift Valley Fever Virus Vaccine in Healthy Adults

A Phase 1 study testing ChAdOx1 RVF and Saline in people with RVF and Rift Valley Fever, run by University of Oxford at 1 site in Uganda.

Completed

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

Official record
Search all trials

Trial summary

Randomised, single blind, placebo - controlled, dose-escalation, phase I clinical trial recruiting healthy adults aged 18-50 years Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
RVF, Rift Valley Fever
What is being tested?
ChAdOx1 RVF and Saline
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUganda
Study dates
31 May 2022to 15 Dec 2022
Phase
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:
  • 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
Show all 12Show fewer
  • 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.
  • Willing to provide verifiable identification to the study team
  • Volunteer must have a means to be contacted or be willing to provide locator information to the study team
  • Volunteer must pass the Test of Understanding (TOU)

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 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
Show all 22Show fewer
  • 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 (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
  • Acute illness or temperature ≥37.5°C/99.5°F on the day of vaccination. Volunteer may be rescheduled for enrolment at a later date.
  • Major surgery (per the investigator's judgement) within 4 weeks prior to screening or planned major surgery through the course of the study
  • Any other serious chronic illness requiring hospital specialist supervision
  • Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 14 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, haematology and coagulation 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
  • Prior natural exposure to RVFV as determined by seropositivity for RVFV antigens by ELISA.

Trial locations and contacts

1 site in 1 country.

Uganda1 site

  • MRC/UVRI and LSHTM Uganda Research Unit

    Entebbe

Other trials in Uganda

About this study

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

Randomised, single blind, placebo - controlled, dose-escalation, phase I clinical trial recruiting healthy adults aged 18-50 years

Read the detailed description

This is a randomised, single blind, placebo-controlled, dose escalation, phase I clinical trial to assess the safety and immunogenicity of the candidate ChAdOx1 RVF vaccine in healthy Ugandan volunteers aged 18-50. The vaccine will be administered intramuscularly.

This study will run concurrently with the first-in-human ChAdOx1 RVF trial in Oxford. Vaccination at the MRC/UVRI and LSHTM Uganda Research Unit, Masaka will only begin upon receiving a favourable opinion of Uganda's trial DSMB of the 7-day post-vaccination safety analysis of the first two lowest dose groups (ChAdOx1 RVF 5 x 10^9vp and ChAdOx1 RVF 2.5 x 10^10vp) of the trial in Oxford.

Volunteers will be recruited and vaccinated at the MRC/UVRI and LSHTM Uganda Research Unit Clinical Research Centre in Masaka. There will be three study groups and a total of 30 volunteers will be enrolled (table 3). Volunteers will be recruited sequentially into Groups 1,2 and 3. Within each group, eligible volunteers will be randomly allocated to receive either ChAdOx1 RVF or placebo of 0.9% Normal Saline in a ratio of 2:1 in group 1 and 5:1 in groups 2 and 3. The DSMB will analyse the 7-day post-vaccination safety data in each group and advise on whether to proceed to the next group with a higher dose .

Being tested
ChAdOx1 RVF, Saline
Keywords
Rift Valley Fever, Vaccine, ChAdOx1
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 ChAdOx1 vectored vaccine

  • SalineOther

    0.5ml saline placebo

Study groups in NCT04672824
Study groupRoleWhat they receive
ChAdOx1 RVF group 1ExperimentalParticipants will receive ChAdOx1 RVF 5 x 10^9 vp, delivered intramuscularly
Receives: Biological: ChAdOx1 RVF
Control groupActive comparatorPlacebo (Normal Saline), 0.5ml delivered intramuscularly
Receives: Other: Saline
ChAdOx1 RVF group 2ExperimentalParticipants will receive ChAdOx1 RVF 2.5 x 10^10 vp, delivered intramuscularly
Receives: Biological: ChAdOx1 RVF
ChAdOx1 RVF group 3ExperimentalParticipants will receive ChAdOx1 RVF 5 x 10^10 vp, delivered intramuscularly
Receives: Biological: ChAdOx1 RVF

What is being measured

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

  1. Assess the safety profile of the candidate vaccine ChAdOx1 RVF in healthy adult volunteers in Uganda: AE

    Occurrence of solicited local reactogenicity signs and symptoms for 7 days following the vaccination, occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination, occurrence of unsolicited adverse events for 28 days following the vaccination, and occurrence of serious adverse events during the whole study duration

    Measured: 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

    Change from baseline for safety laboratory measures: clinical blood test adverse events (full blood count, liver function tests and renal function) graded on a scaled adapted from the FDA healthy volunteer vaccine scale

    Measured: The study duration: 3 months from vaccination

Secondary outcomes (3)

  1. Assess the immunogenicity of the candidate vaccine ChAdOx1 RVF in healthy adult volunteers in Uganda: GnGc protein antibodies

    Measures of immunogenicity to the ChAdOx1 RVF vaccine:

    • ELISA to quantify antibodies to GnGc proteins

    Measured: The study duration: 3 months from vaccination

  2. Assess the immunogenicity of the candidate vaccine ChAdOx1 RVF in healthy adult volunteers in Uganda: RVFV neutralising antibodies

    Measures of immunogenicity to the ChAdOx1 RVF vaccine:

    • RVFV neutralising antibody titres

    Measured: The study duration: 3 months from vaccination

  3. Assess the immunogenicity of the candidate vaccine ChAdOx1 RVF in healthy adult volunteers in Uganda: ELISpot & flow cytometry

    Measures of immunogenicity to the ChAdOx1 RVF vaccine:

    • Ex vivo ELISpot and flow cytometry responses to GnGc

    Measured: The study duration: 3 months from vaccination

Timeline

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

  1. First posted17 Dec 2020
  2. Study start31 May 2022
  3. Primary completion15 Dec 2022
  4. Study completion15 Dec 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
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04672824
Sponsor's protocol ID
RVF002
Status last verified
Jan 2023
First submitted
19 Oct 2020
Last updated
6 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Anywaine Z, Serwanga J, Ggayi AM, Abaasa AM, Wright D, Gombe B, Ejou P, Namata T, Kigozi A, Tukamwesiga N, Basajja V, Ankunda V, Mulondo DJ, Nambaziira F, Kakande A, Kakeeto W, Nabaggala P, Jenkin D, Lawrie A, Folegatti P, Tran N, Hansen C, Elliott AM, Hill AVS, Warimwe GM, Kaleebu P. Safety, tolerability, and immunogenicity of the ChAdOx1 RVF vaccine against Rift Valley fever among healthy adults in Uganda: a single-centre, single-blind, randomised, placebo-controlled, dose-escalation, phase 1 trial. Lancet Infect Dis. 2026 Mar;26(3):302-313. doi: 10.1016/S1473-3099(25)00565-1. Epub 2025 Nov 11.

    PubMed 41237791

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ChAdOx1 RVF and Saline in people with RVF and Rift Valley Fever, run by University of Oxford at 1 site in Uganda.

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 12 inclusion and 22 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 6 Feb 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 Uganda. 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Assess the safety profile of the candidate vaccine ChAdOx1 RVF in healthy adult volunteers in Uganda: AE (time frame: The study duration: 3 months from vaccination). The study lists 2 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 NCT04672824, 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 6 Feb 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in