Ebola
Conditions
Interventions
Concurrent vaccination with Ervebo and Cominarty
Vaccination with Ervebo with concurrent administration of Placebo
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion 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 WHO approved primary immunisation course is acceptable).
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary safety objective: Rates of solicited systemic adverse reactions graded as 3 or 4 severities within one week of concurrent vaccine dose administration, compared to when rVSV?G-ZEBOV-GP vaccine is given alone. Primary immunogenicity objective: Serum anti-GP antibody responses 28-days after concurrent vaccine dose administration, compared to when rVSV?G-ZEBOV-GP vaccine is given alone. | — |
Secondary
| Measure | Time frame |
|---|---|
| To longitudinally assess humoral immunogenicity to rVSV?G-ZEBOV-GP when co-administered with BioNTech – Pfizer COVID-19 booster vaccination, compared to when rVSV?G-ZEBOV-GP vaccine is given alone. | — |
Countries
Rwanda
Contacts
Public ContactSiobhan Roche
Vaccine Research Project Manager
Outcome results
None listed