Trials Sponsors Conditions Drugs Pricing

Conditions

Rift Valley Fever

Keywords

RVFChAdOx1vaccine

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 RVFBiological

Single dose of ChAdOx1 RVF

High doseLow doseMedium dose

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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

Sponsors & Collaborators

University of Oxford
Otherlead

Study Sites (1)

CCVTM, University of Oxford, Churchill Hospital

Oxford, OX3 7LE, United Kingdom

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: 37060917DERIVED

MeSH Terms

Conditions

Rift Valley Fever

Condition Hierarchy (Ancestors)

Hepatitis, Viral, AnimalHepatitis, AnimalInfectionsMosquito-Borne DiseasesVector Borne DiseasesArbovirus InfectionsVirus DiseasesBunyaviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, ViralHepatitisLiver DiseasesDigestive System DiseasesAnimal Diseases

Study Officials

Adrian VS Hill, Prof
Jenner Institute
PRINCIPAL INVESTIGATOR

Enrollment

15 participants (actual enrollment reported by the registry).

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

Actual (reported)

Safety and Immunogenicity of a Candidate RVFV Vaccine (RVF001)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (3)

Study Arms (3)

Low dose

Medium dose

High dose

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (3)

Study Arms (3)

Low dose

Medium dose

High dose

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations