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

NCT04672824 | Completed Phase 1 DMC

• 1 other identifier: RVF002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

RVF; Rift Valley Fever

Keywords

Rift Valley Fever; Vaccine; ChAdOx1

Outcome Measures

Primary Outcomes (2)

• 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

  The study duration: 3 months from vaccination

• 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

  The study duration: 3 months from vaccination

Secondary Outcomes (3)

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

  The study duration: 3 months from vaccination

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

  The study duration: 3 months from vaccination

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

  The study duration: 3 months from vaccination

Study Arms (4)

ChAdOx1 RVF group 1

EXPERIMENTAL

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

Biological: ChAdOx1 RVF

Control group

ACTIVE COMPARATOR

Placebo (Normal Saline), 0.5ml delivered intramuscularly

Other: Saline

ChAdOx1 RVF group 2

EXPERIMENTAL

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

Biological: ChAdOx1 RVF

ChAdOx1 RVF group 3

EXPERIMENTAL

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

Biological: ChAdOx1 RVF

Interventions

ChAdOx1 RVF BIOLOGICAL

Single dose ChAdOx1 vectored vaccine

ChAdOx1 RVF group 1; ChAdOx1 RVF group 2; ChAdOx1 RVF group 3

Saline OTHER

0.5ml saline placebo

Control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Oxford: lead
• MRC/UVRI and LSHTM Uganda Research Unit: collaborator

Study Sites (1)

MRC/UVRI and LSHTM Uganda Research Unit

Entebbe, Uganda

Location

Related Publications (1)

• 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. 2025 Nov 11:S1473-3099(25)00565-1. doi: 10.1016/S1473-3099(25)00565-1. Online ahead of print.

  PMID: 41237791 DERIVED

MeSH Terms

Conditions

Rift Valley Fever

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Animal; Hepatitis, Animal; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Arbovirus Infections; Virus Diseases; Bunyaviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral; Hepatitis; Liver Diseases; Digestive System Diseases; Animal Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Pontiano Kaleebu, PhD

  MRC/UVRI and LSHTM Uganda Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: December 17, 2020
• Study Start: May 31, 2022
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)