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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Birmingham

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • BioNTech - Pfizer COVID-19 vaccine

    Biological/Vaccine

    Vaccine for protection from COVID-19

  • 1mL saline solution

    Biological/Vaccine

    Placebo

  • rVSV∆G-ZEBOV-GP

    Biological/Vaccine

    Vaccine for protection from Zaire Ebola virus

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 2 interventions
Group B: Concurrent vaccinationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 7 post vaccination
2

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

Time frame
Day 28 post vaccination

Secondary outcomes

1

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.

Time frame
Day 180 post vaccination

Other outcomes

Locations

This trial has no 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

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