Trials Sponsors Conditions Drugs Pricing

Conditions

Rift Valley Fever RVF

Keywords

Rift Valley FeverVaccineChAdOx1

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

Interventions

ChAdOx1 RVFBiological

Single dose ChAdOx1 vectored vaccine

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

SalineOther

0.5ml saline placebo

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:
Male and female healthy adults aged 18 to 50 years

Sponsors & Collaborators

MRC/UVRI and LSHTM Uganda Research Unit
Othercollaborator
University of Oxford
Otherlead

Study Sites (1)

MRC/UVRI and LSHTM Uganda Research Unit

Entebbe, Uganda

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. 2026 Mar;26(3):302-313. doi: 10.1016/S1473-3099(25)00565-1. Epub 2025 Nov 11.
PMID: 41237791DERIVED

MeSH Terms

Conditions

Rift Valley Fever

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

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

Study Officials

Pontiano Kaleebu, PhD
MRC/UVRI and LSHTM Uganda Research Unit
PRINCIPAL INVESTIGATOR

Enrollment

30 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (4)

ChAdOx1 RVF group 1

Control group

ChAdOx1 RVF group 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

ChAdOx1 RVF group 3

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

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 (2)

Secondary Outcomes (3)

Study Arms (4)

ChAdOx1 RVF group 1

Control group

ChAdOx1 RVF group 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

ChAdOx1 RVF group 3

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations