Safety and Immunogenicity of rVSVΔG-ZEBOV-GP Vaccination When Dosed Concurrently With mRNA COVID-19 Vaccine Booster Doses

Launched by UNIVERSITY OF BIRMINGHAM · Sep 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of giving two vaccines at the same time: one that protects against the Ebola virus and another that protects against COVID-19. The goal is to see if receiving both vaccines together is safe for healthy adults and if it generates a strong immune response, which means how well the body can fight off these viruses. This research is particularly important for groups like healthcare workers in Rwanda, who play a critical role in managing infectious diseases.

To participate in this trial, you must be a healthy adult aged between 18 and 50 years old who has already received a full course of a COVID-19 vaccine. You will need to agree to follow all the study guidelines and provide written consent. If you have had an Ebola vaccine before, have certain health conditions, or are pregnant or breastfeeding, you won’t be able to join. Participants will receive both vaccines and will be monitored for any side effects or reactions, helping researchers understand how well these vaccines work together.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.