Safety and Immunogenicity of Ervebo® and Zabdeno® Booster Vaccines Against Ebola Virus Following Previous Vaccination with the Zabdeno/Mvabea® or Ervebo® Vaccine Schedules in DRC

NCT06126822 | Recruiting Phase 3

• 1 other identifier: 1706/23
• Study Type: interventional
• Target: 624
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this randomized controlled trial is to investigate whether individuals in DRC previously vaccinated with Zabdeno/Mvabea® or Ervebo® vaccine schedules against Ebola virus can be safely and adequately boosted with homologous or heterologous vaccine schedules. Participants will be randomized to receive either a homologous or heterologous vaccine schedule and will be asked to come to the clinic at prespecified timepoints over a period of 6 months to collect blood samples for comparison of immunological responses against Ebola virus between both schedules. Safety and tolerability of the vaccines will be evaluated by recording Adverse Events (AE's) and grading physical and vital signs evaluations.

Conditions

Ebola Virus Disease

Keywords

Ebola vaccines

Outcome Measures

Primary Outcomes (1)

• To assess non-inferiority in EBOV-specific IgG levels elicited by a heterologous to a homologous booster vaccine schedule, by type of primary vaccination, 21 days after administration of the booster.

  FANG ELISA units/mL of anti-EBOV IgG

  Day 21 after booster vaccination = Day 21

Secondary Outcomes (14)

• To assess the safety of heterologous and homologous booster vaccine schedules, by type of primary vaccine schedule

  Day 7, Day 21 and Month 6

• To compare the EBOV-specific IgG levels at D21 across all vaccine combinations

  Day 21

• To compare the fold change between D0 and D21 across all vaccine combinations

  Day 0 and Day 21

• To compare the EBOV-specific binding and neutralizing antibodies to the glycoproteins of different EBOV variants across all vaccine combinations and timepoints

  Day 0, Day 3, Day 7, Day 21, Month 6

• To compare the EBOV-specific binding and neutralizing antibodies to the glycoproteins of different EBOV variants across all vaccine combinations and timepoints

  Day 0, Day 21, Month 6

Study Arms (4)

Zabdeno/Mvabea® vaccinated - Zabdeno® booster

EXPERIMENTAL

Participants previously vaccinated with the Zabdeno/Mvabea® vaccination schedule, will receive a single intramuscular Zabdeno® booster vaccine (0,5 ml) = homologous vaccination scheme.

Drug: Zabdeno® booster

Zabdeno/Mvabea® vaccinated - Ervebo® booster

EXPERIMENTAL

Participants previously vaccinated with the Zabdeno/Mvabea® vaccination schedule, will receive a single intramuscular Ervebo® booster vaccine (1 ml) = heterologous vaccination scheme.

Drug: Ervebo® booster

Ervebo® vaccinated - Ervebo® booster

EXPERIMENTAL

Participants previously vaccinated with Ervebo®, will receive a single intramuscular Ervebo® booster vaccine (1 ml) = homologous vaccination scheme.

Drug: Ervebo® booster

Ervebo® vaccinated - Zabdeno® booster

EXPERIMENTAL

Participants previously vaccinated with Ervebo®, will receive a single intramuscular Zabdeno® booster vaccine (0,5 ml) = heterologous vaccination scheme.

Drug: Zabdeno® booster

Interventions

Zabdeno® booster DRUG

A single Zabdeno® booster vaccination

Ervebo® vaccinated - Zabdeno® booster; Zabdeno/Mvabea® vaccinated - Zabdeno® booster

Ervebo® booster DRUG

A single Ervebo® booster vaccination

Ervebo® vaccinated - Ervebo® booster; Zabdeno/Mvabea® vaccinated - Ervebo® booster

Eligibility Criteria

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

You may qualify if:

• Subjects who received either the Ervebo® vaccine (MSD), or the full Zabdeno, Mvabea® vaccine regimen (J\&J) more than 4 months prior to recruitment
• Subjects between 18 and 50 years of age at time of randomization
• Subject must be willing and able to provide informed consent
• The subject must be in possession of an identification card (or other identification document)
• Agreement to refrain from blood donation and other vaccinations 30 days after booster vaccination
• Agreement to share and discuss participant's medical history, medical records and concomitant medications when relevant

You may not qualify if:

• Participants who previously experienced active Ebola Virus Disease (EVD)
• Receipt of any vaccine (licensed or experimental) within 30 days prior to recruitment
• Receipt of an additional booster dose of either Ervebo®, Zabdeno®, or any experimental Ebola vaccine
• Incorrect or incomplete primary vaccination scheme with the Zabdeno, Mvabea® (J\&J) vaccine
• Administration of immunoglobulins and/or any blood products within three months prior to recruitment.
• Fever (\>38°C) within last 24 hours prior to recruitment.
• Any confirmed or suspected immunosuppressive or immunodeficient state (incl. cancer and HIV); asplenia; recurrent severe infections and use of immunosuppressant medication within the last 6 months, except topical or short-term oral steroids.
• Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed)
• History of anaphylaxis, allergic disease or reactions to any component of the study vaccines
• History of bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture
• History of any thrombotic disorder, thrombocytopenia, thrombotic thrombocytopenia syndrome (TTP), or heparin-induced thrombocytopenia and thrombosis (HITT)
• Any other significant disease, disorder, planned surgery, or finding which may significantly affect the ability of the volunteer to participate in the study or impair interpretation of the study data
• Suspected or known alcohol or drug dependency
• Subject is not readily available by telephone, email or physical address
• Agreement to refrain from blood donation and other vaccinations 30 days after study vaccination

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• Institut National pour la Recherche Biomedicale (INRB): collaborator

Study Sites (2)

Institut National de Recherche Biomédicale (INRB)

Goma, Democratic Republic of the Congo

NOT YET RECRUITING

Institut National de Recherche Biomédicale (INRB)

Kinshasa, Democratic Republic of the Congo

RECRUITING

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Study Officials

• Wim Adriaensen, Prof.

  Institute of Tropical Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wim Adriaensen, Prof.

CONTACT

+32(0)33455909; wadriaensen@itg.be

Selien Oostvogels Oostvogels

CONTACT

soostvogels@itg.be

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: November 13, 2023
• Study Start: February 25, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)