Safety and Immunogenicity of a Candidate RVFV Vaccine (RVF001)

NCT04754776 | Completed Early Phase 1 DMC

• 1 other identifier: RVF001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Rift Valley Fever

Keywords

RVF; ChAdOx1; vaccine

Outcome Measures

Primary Outcomes (5)

• To assess local reactogenicity

  Occurrence of solicited local reactogenicity signs and symptoms

  7 days following vaccination

• To assess systemic reactogenicity

  Occurrence of solicited systemic reactogenicity signs and symptoms

  7 days following vaccination

• To assess unsolicited adverse events

  Occurrence of unsolicited adverse events

  28 days following vaccination

• 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)

  Duration of study (6 months)

• To assess serious adverse events

  Occurrence of serious adverse events

  Duration of study (6 months)

Secondary Outcomes (3)

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

  Duration of study (6 months)

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

  Duration of study (6 months)

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

  Duration of study (6 months)

Study Arms (3)

Low dose

EXPERIMENTAL

5 x 10\^9 vp ChAdOx1 RVF delivered intramuscularly

Biological: ChAdOx1 RVF

Medium dose

EXPERIMENTAL

2.5 x 10\^10 vp ChAdOx1 RVF delivered intramuscularly

Biological: ChAdOx1 RVF

High dose

EXPERIMENTAL

5 x 10\^10 vp ChAdOx1 RVF delivered intramuscularly

Biological: ChAdOx1 RVF

Interventions

ChAdOx1 RVF BIOLOGICAL

Single dose of ChAdOx1 RVF

High dose; Low dose; Medium dose

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:
• 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

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 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
• 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

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

CCVTM, University of Oxford, Churchill Hospital

Oxford, OX3 7LE, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37060917 DERIVED

MeSH Terms

Conditions

Rift Valley Fever

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

Study Officials

• Adrian VS Hill, Prof

  Jenner Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 15, 2021
• Study Start: June 11, 2021
• Primary Completion: April 6, 2022
• Study Completion: April 6, 2022
• Last Updated: May 19, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)