About this trial
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 diseases. This is a phase IV vaccine trial that looks to establish if two licenced vaccines, the rVSVΔG-ZEBOV-GP vaccine for protection against Ebola virus and messenger ribonucleic acid (mRNA) COVID vaccine for protection against SARS-CoV-2 virus, given concurrently to self selected healthy adult volunteers confers an acceptable safety profile and immunogenicity response.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
BioNTech - Pfizer COVID-19 vaccine
Biological/VaccineVaccine for protection from COVID-19
1mL saline solution
Biological/VaccinePlacebo
rVSV∆G-ZEBOV-GP
Biological/VaccineVaccine for protection from Zaire Ebola virus
Treatment groups
Trial outcomes
Primary outcomes
Incidence of treatment related adverse events in the seven days following vaccination
Rates of severe treatment related adverse events within one week of concurrent vaccine dose administration, compared to when rVSVΔG-ZEBOV-GP vaccine is given alone.
Day 28 serum anti-glycoprotein (GP) antibody responses
Serum anti-glycoprotein (GP) antibody responses 28-days after concurrent vaccine dose administration, compared to when rVSVΔG-ZEBOV-GP vaccine is given alone
Secondary outcomes
Day 28 and day 180 serum anti-GP and serum SARS-CoV-2 anti-Spike protein specific geometric mean titres
Longitudinal assessment of serum anti-GP and serum SARS-CoV-2 anti-Spike protein specific geometric mean titres after concurrent vaccine dose administration, compared to when rVSVΔG-ZEBOV-GP vaccine is given alone.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Birmingham
Lead sponsor
Project San Francisco
Collaborator
Rwanda Biomedical Centre
Collaborator
Merck Sharp & Dohme LLC
Collaborator
This trial is not recruiting at the moment. You can still explore other options: