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

NCT06587503 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: EbolaCovPACTR202407764378004
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Ebola Virus Disease; COVID-19

Outcome Measures

Primary Outcomes (2)

• 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 7 post vaccination

• 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

  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

  Day 180 post vaccination

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Receive an intramuscular injection of a placebo concurrently with a dose of rVSV∆G-ZEBOV-GP vaccine

Biological: 1mL saline solution; Biological: rVSV∆G-ZEBOV-GP

Concurrent vaccination

EXPERIMENTAL

Receive an intramuscular dose of BioNTech - Pfizer COVID-19 concurrently with a dose of rVSV∆G-ZEBOV-GP vaccine

Biological: BioNTech - Pfizer COVID-19 vaccine; Biological: rVSV∆G-ZEBOV-GP

Interventions

BioNTech - Pfizer COVID-19 vaccine BIOLOGICAL

Vaccine for protection from COVID-19

Also known as: Cominarty

Concurrent vaccination

1mL saline solution BIOLOGICAL

Placebo

Also known as: rVSV∆G-ZEBOV-GP

Placebo

rVSV∆G-ZEBOV-GP BIOLOGICAL

Vaccine for protection from Zaire Ebola virus

Also known as: Ervebo

Concurrent vaccination; Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Birmingham: lead
• Project San Francisco: collaborator
• Rwanda Biomedical Centre: collaborator
• Merck Sharp & Dohme LLC: collaborator

Related Publications (1)

• Gokani K, Taylor A, Packham A, Musabyimana JP, Shema H, Mutabaruka A, Roche S, Takwoingi Y, Umuhoza C, Nyombayire J, Muvunyi C, Green C. Safety and immunogenicity of rVSVDeltaG-ZEBOV-GP vaccination when dosed concurrent with mRNA COVID-19 vaccine booster doses in healthy African adults (EbolaCov): protocol for a phase IV, single-centre, single-blinded, randomised controlled trial. BMJ Open. 2025 Sep 21;15(9):e102898. doi: 10.1136/bmjopen-2025-102898.

  PMID: 40976661 DERIVED

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola; COVID-19

Interventions

BNT162 Vaccine; Saline Solution

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Christopher Green, PhD

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julien Nyombayire, MD, MSc

CONTACT

+250 252 503 233; jnyombayire@rzhrg-mail.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data requests can be submitted starting immediately after article publication and the data will be made accessible for up to 5 years. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a methodologically sound research proposal. Data must be required to achieve the aims in the approved proposal. Data requests should be directed to c.a.green.2@bham.ac.uk.