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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04672824
Recruitment Status : Completed
First Posted : December 17, 2020
Last Update Posted : February 6, 2023
Sponsor:
Collaborator:
MRC/UVRI and LSHTM Uganda Research Unit
Information provided by (Responsible Party):
University of Oxford

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

Condition or disease Intervention/treatment Phase
RVF Rift Valley Fever Biological: ChAdOx1 RVF Other: Saline Phase 1

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 .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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
Actual Study Start Date : May 31, 2022
Actual Primary Completion Date : December 15, 2022
Actual Study Completion Date : December 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ChAdOx1 RVF group 1
Participants will receive ChAdOx1 RVF 5 x 10^9 vp, delivered intramuscularly
Biological: ChAdOx1 RVF
Single dose ChAdOx1 vectored vaccine

Active Comparator: Control group
Placebo (Normal Saline), 0.5ml delivered intramuscularly
Other: Saline
0.5ml saline placebo

Experimental: ChAdOx1 RVF group 2
Participants will receive ChAdOx1 RVF 2.5 x 10^10 vp, delivered intramuscularly
Biological: ChAdOx1 RVF
Single dose ChAdOx1 vectored vaccine

Experimental: ChAdOx1 RVF group 3
Participants will receive ChAdOx1 RVF 5 x 10^10 vp, delivered intramuscularly
Biological: ChAdOx1 RVF
Single dose ChAdOx1 vectored vaccine




Primary Outcome Measures :
  1. 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 ]
    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

  2. Assess the safety profile of the candidate vaccine ChAdOx1 RVF in healthy adult volunteers in Uganda: change in baseline: AE [ Time Frame: The study duration: 3 months from vaccination ]
    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


Secondary Outcome Measures :
  1. Assess the immunogenicity of the candidate vaccine ChAdOx1 RVF in healthy adult volunteers in Uganda: GnGc protein antibodies [ Time Frame: The study duration: 3 months from vaccination ]

    Measures of immunogenicity to the ChAdOx1 RVF vaccine:

    * ELISA to quantify antibodies to GnGc proteins


  2. Assess the immunogenicity of the candidate vaccine ChAdOx1 RVF in healthy adult volunteers in Uganda: RVFV neutralising antibodies [ Time Frame: The study duration: 3 months from vaccination ]

    Measures of immunogenicity to the ChAdOx1 RVF vaccine:

    * RVFV neutralising antibody titres


  3. Assess the immunogenicity of the candidate vaccine ChAdOx1 RVF in healthy adult volunteers in Uganda: ELISpot & flow cytometry [ Time Frame: The study duration: 3 months from vaccination ]

    Measures of immunogenicity to the ChAdOx1 RVF vaccine:

    * Ex vivo ELISpot and flow cytometry responses to GnGc




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04672824


Locations
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Uganda
MRC/UVRI and LSHTM Uganda Research Unit
Entebbe, Uganda
Sponsors and Collaborators
University of Oxford
MRC/UVRI and LSHTM Uganda Research Unit
Investigators
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Principal Investigator: Pontiano Kaleebu, PhD MRC/UVRI and LSHTM Uganda Research Unit
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT04672824    
Other Study ID Numbers: RVF002
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: February 6, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oxford:
Rift Valley Fever
Vaccine
ChAdOx1
Additional relevant MeSH terms:
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Coccidioidomycosis
Coccidiosis
Rift Valley Fever
Fever
Hemorrhagic Fevers, Viral
Body Temperature Changes
Mycoses
Bacterial Infections and Mycoses
Infections
Protozoan Infections
Parasitic Diseases
Hepatitis, Viral, Animal
Hepatitis, Animal
Arbovirus Infections
Vector Borne Diseases
Virus Diseases
Bunyaviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases