Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202407764378004 Date of Approval: 30/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EbolaCov
Official scientific title EbolaCov: A phase IV, single-centre, single-blinded, randomized controlled trial to assess safety and immunogenicity of rVSVΔG-ZEBOV-GP vaccination when dosed concurrent with mRNA COVID-19 vaccine booster doses in healthy African adults.
Brief summary describing the background and objectives of the 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 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.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Ebola
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 15/09/2024
Actual trial start date
Anticipated date of last follow up 05/05/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 72
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Concurrent vaccination with Ervebo and Cominarty One dose of each vaccine as per SmPC in each arm Single dose of each Concurrent vaccination with Ervebo and Cominarty 36
Control Group Vaccination with Ervebo with concurrent administration of Placebo 1 dose of Ervebo as per SmPC and 1mL saline solution as Placebo One dose of each Concurrent administration of Ervebo and Placebo 36 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• 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). • 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. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 11/05/2024 Rwanda national ethics committee
Ethics Committee Address
Street address City Postal code Country
Ministry of health KN 3 RD Kigali 00000 Rwanda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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 rVSVΔG-ZEBOV-GP vaccine is given alone. Primary immunogenicity objective: Serum anti-GP antibody responses 28-days after concurrent vaccine dose administration, compared to when rVSVΔG-ZEBOV-GP vaccine is given alone. Safety objective: 7 days post vaccination, Immunogenicity objective: day 28
Secondary Outcome To longitudinally assess humoral immunogenicity to rVSVΔG-ZEBOV-GP when co-administered with BioNTech – Pfizer COVID-19 booster vaccination, compared to when rVSVΔG-ZEBOV-GP vaccine is given alone. Day 180
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Center for Family Health Research KK 19 Av, No. 57, Kigali BP 780 Rwanda
FUNDING SOURCES
Name of source Street address City Postal code Country
MSD 120 Moorgate London EC2M 6UR United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Birmingham Edgbaston Birmingham United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Rwanda Biomedical Centre KG 644 St Kigali Rwanda
Centre for Family Health Research KK 19 Av, No. 57 Kigali Rwanda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Julien Nyombayire jnyombayire@rzhrg-mail.org +250252503233 KK 19 Av, No. 57, Kicukiro,
City Postal code Country Position/Affiliation
Kigali BP 780 Rwanda Senior research physician
Role Name Email Phone Street address
Scientific Enquiries Karishma Gokani k.gokani@bham.ac.uk +447946036068 University of Birmingham
City Postal code Country Position/Affiliation
Birmingham B15 2TT United Kingdom Sub I Clinical research fellow
Role Name Email Phone Street address
Scientific Enquiries Christopher Green c.a.green.2@bham.ac.uk +4412141433 University of Birmingham
City Postal code Country Position/Affiliation
Birmingham United Kingdom Associate professor
Role Name Email Phone Street address
Public Enquiries Siobhan Roche s.roche@bham.ac.uk +441214143344 University of Birmingham
City Postal code Country Position/Affiliation
Birmingham United Kingdom Vaccine Research Project Manager
Role Name Email Phone Street address
Principal Investigator Christopher Green c.a.green.2@bham.ac.uk +441214143344 University of Birmingham
City Postal code Country Position/Affiliation
London United Kingdom Associate professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data that support the findings of this study are not openly available to protect the confidentiality of study participants. Fully anonymised data are, however, available from the authors upon reasonable request and with permission from MSD, if required. Informed Consent Form,Statistical Analysis Plan,Study Protocol 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 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
URL Results Available Results Summary Result Posting Date First Journal Publication Date
c.a.green.2@bham.ac.uk No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information