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CompletedNCT04672824Updated Feb 6, 2023

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

A Phase 1 interventional study of ChAdOx1 RVF and Saline in RVF and Rift Valley Fever, sponsored by University of Oxford. Completed at 1 site in Uganda. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-06.

Sponsored by University of Oxford · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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 .

02

Conditions studied

  • RVF
  • Rift Valley Fever

Keywords

  • Rift Valley Fever
  • Vaccine
  • ChAdOx1
03

In context

Coccidioidomycosis

25 studies on the registry are indexed under Coccidioidomycosis; 5 are open to participants now.

This study's enrollment of 30 is below the median of 46 across 17 interventional studies indexed under Coccidioidomycosis.

Browse Coccidioidomycosis studies →

Lead sponsor

University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

  1. Male and female healthy adults aged 18 to 50 years
  2. Able and willing to provide written informed consent
  3. Able and willing (in the Investigator's opinion) to comply with all study requirements
  4. For females only, willingness to practice continuous effective contraception during the study.
  5. 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
  6. Agreement to refrain from blood donation during the course of the study
  7. Healthy in the investigator's clinical judgement basing on the medical history and physical examination performed at screening
  8. Healthy on the basis of clinical laboratory tests (within the institutional normal laboratory reference ranges) performed at screening.
  9. Willing to provide verifiable identification to the study team
  10. Volunteer must have a means to be contacted or be willing to provide locator information to the study team
  11. Volunteer must pass the Test of Understanding (TOU)

Exclusion criteria

Exclusion Criteria:

The volunteer may not enter the study if any of the following apply:

  1. Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
  2. Prior receipt of an investigational vaccine as it may impact on interpretation of the trial data.
  3. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
  4. 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)
  5. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
  6. Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
  7. Any history of anaphylaxis in relation to vaccination
  8. Pregnancy, lactation or willingness/intention to become pregnant during the study
  9. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
  10. History of serious psychiatric condition likely to affect participation in the study
  11. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
  12. 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.
  13. Major surgery (per the investigator's judgement) within 4 weeks prior to screening or planned major surgery through the course of the study
  14. Any other serious chronic illness requiring hospital specialist supervision
  15. Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 14 units every week
  16. Suspected or known injecting drug abuse in the 5 years preceding enrolment
  17. Seropositive for hepatitis B surface antigen (HBsAg)
  18. Seropositive for hepatitis C virus (antibodies to HCV)
  19. Any clinically significant abnormal finding on screening biochemistry, haematology and coagulation blood tests or urinalysis
  20. 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
  21. Prior natural exposure to RVFV as determined by seropositivity for RVFV antigens by ELISA.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    ChAdOx1 RVF group 1

    Participants will receive ChAdOx1 RVF 5 x 10\^9 vp, delivered intramuscularly

    Biological: ChAdOx1 RVF

  • Active comparator
    Control group

    Placebo (Normal Saline), 0.5ml delivered intramuscularly

    Other: Saline

  • Experimental
    ChAdOx1 RVF group 2

    Participants will receive ChAdOx1 RVF 2.5 x 10\^10 vp, delivered intramuscularly

    Biological: ChAdOx1 RVF

  • Experimental
    ChAdOx1 RVF group 3

    Participants will receive ChAdOx1 RVF 5 x 10\^10 vp, delivered intramuscularly

    Biological: ChAdOx1 RVF

Interventions

  • BiologicalChAdOx1 RVF

    Single dose ChAdOx1 vectored vaccine

  • OtherSaline

    0.5ml saline placebo

06

What researchers measure

Primary outcomes

  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

    Time frame: 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

    Time frame: The study duration: 3 months from vaccination

Secondary outcomes

  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

    Time frame: 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

    Time frame: 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

    Time frame: The study duration: 3 months from vaccination

07

Study locations

1 site
  • MRC/UVRI and LSHTM Uganda Research Unit
    Entebbe, Uganda
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04672824
Lead sponsor
University of Oxford
Collaborators
MRC/UVRI and LSHTM Uganda Research Unit
Responsible party
Sponsor
First posted
Dec 17, 2020
Start date
May 31, 2022
Primary completion
Dec 15, 2022
Completion
Dec 15, 2022
Last update
Feb 6, 2023

Study contacts

Pontiano Kaleebu, PhD
principal investigator · MRC/UVRI and LSHTM Uganda Research Unit

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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