Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04754776
Status:
COMPLETED
Last Update Posted:
2023-05-19
First Post:
2021-02-05
Brief Title:
Safety and Immunogenicity of a Candidate RVFV Vaccine RVF001
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
A Phase I Study to Determine the Safety Immunogenicity of the Candidate Rift Valley Fever Virus RVFV Vaccine ChAdOx1 RVF in UK Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
The purpose of this study is to test a new vaccine against the Rift Valley Fever Virus RVFV in healthy volunteers
Rift Valley fever is a disease caused by RVFV and it is transmitted to humans through a mosquito bite or contact with virus-contaminated tissues and fluids Although initially restricted to Africa the virus can be transmitted by several different mosquito species that are more widely distributed than the virus itself leading to concerns of disease spread as has occurred in the Arabian Peninsula and Madagascar In humans RVFV infection usually presents as a sudden febrile illness but severe manifestations including bleeding disorders and neurological complications may also occur RVFV is considered a global health threat with significant potential for international spread and use in bioterrorism
Vaccines against RVFV are available for livestock however no licensed vaccines or specific treatments are currently available for humans
The study will enable assessment of the safety of the new vaccine called ChAdOx1 RVF and the extent of immune response in healthy volunteers Healthy adult volunteers will receive a single dose of a new candidate vaccine at different doses The objective of this first-in-human study is to find the optimal dose of the vaccine balancing immune responses and profile of adverse events
Healthy volunteers aged 18-50 will be recruited in Oxford and vaccinated at the Centre for Clinical Vaccinology and Tropical Medicine and will be followed for a period of 3 months The study is funded by the UK Biotechnology and Biological Sciences Research CouncilBBSRC and the Medical Research Council MRCDepartment of Health through the UK Vaccines Network
Rift Valley fever is a disease caused by RVFV and it is transmitted to humans through a mosquito bite or contact with virus-contaminated tissues and fluids Although initially restricted to Africa the virus can be transmitted by several different mosquito species that are more widely distributed than the virus itself leading to concerns of disease spread as has occurred in the Arabian Peninsula and Madagascar In humans RVFV infection usually presents as a sudden febrile illness but severe manifestations including bleeding disorders and neurological complications may also occur RVFV is considered a global health threat with significant potential for international spread and use in bioterrorism
Vaccines against RVFV are available for livestock however no licensed vaccines or specific treatments are currently available for humans
The study will enable assessment of the safety of the new vaccine called ChAdOx1 RVF and the extent of immune response in healthy volunteers Healthy adult volunteers will receive a single dose of a new candidate vaccine at different doses The objective of this first-in-human study is to find the optimal dose of the vaccine balancing immune responses and profile of adverse events
Healthy volunteers aged 18-50 will be recruited in Oxford and vaccinated at the Centre for Clinical Vaccinology and Tropical Medicine and will be followed for a period of 3 months The study is funded by the UK Biotechnology and Biological Sciences Research CouncilBBSRC and the Medical Research Council MRCDepartment of Health through the UK Vaccines Network
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None