Status:
NOT_YET_RECRUITING
Safety and Immunogenicity of rVSVΔG-ZEBOV-GP Vaccination When Dosed Concurrently With mRNA COVID-19 Vaccine Booster Doses
Lead Sponsor:
University of Birmingham
Collaborating Sponsors:
Project San Francisco
Rwanda Biomedical Centre
Conditions:
Ebola Virus Disease
COVID-19
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief Summary
Concurrent vaccination scheduling for key target populations in Rwanda, such as healthcare workers, may confer significant advantages in the provision of vaccine coverage to several infectious disease...
Detailed Description
Vaccines for the prevention of severe disease caused by Ebola virus and SARS-CoV-2 virus are routinely offered to adults at higher risk of exposure in African settings. For protection from Ebola virus...
Eligibility Criteria
Inclusion
- Healthy male and female adults between ages 18-50 years, who are able and willing to provide written informed consent and will comply with the study requirements.
- Already completed a primary course of COVID-19 immunisation (any World Health Organisation approved primary immunisation course is acceptable).
Exclusion
- Unwilling or unable to provide written informed consent to take part
- Unwilling or unable to comply with study procedures
- Previously received an Ebola vaccine or previous exposure to Ebola virus (including serological and clinical diagnoses, irrespective of viral strain)
- Not received a primary course of COVID-19 immunisation
- History of any suspected or confirmed disorder of the immune system that, in the opinion of the Investigators, might impair the results of the study
- Use of immunosuppressant medication within the past 6 months (excluding topical steroids or oral steroid courses lasting \<7 days)
- Current diagnosis or treatment of cancer (unless non-melanomatous skin cancer)
- Have a bleeding disorder deemed significant by study doctor
- Pregnant or breast-feeding females
- Able to avoid close contact with vulnerable individuals, including via high-risk blood and bodily fluids for 6 weeks following vaccination to reduce the risk of transmission to vulnerable individuals (e.g. immuno-compromised individuals, individuals receiving immunosuppressive therapy, pregnant or breast-feeding women, children \<1 year of age).
- Unable to prevent contact of their blood or bodily fluids with farm animals in the 6 weeks following vaccination
- Plan to donate blood in the 6 weeks following vaccination
- Hypersensitivity to any active substances, excipients, or rice protein.
- History of anaphylaxis to any component of vaccine formulation.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06587503
Start Date
October 1 2024
End Date
May 1 2025
Last Update
September 19 2024
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