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Effectiveness and Safety of a Heterologous, Two-dose Ebola Vaccine in the DRC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04152486
Recruitment Status : Unknown
Verified June 2021 by London School of Hygiene and Tropical Medicine.
Recruitment status was:  Active, not recruiting
First Posted : November 5, 2019
Last Update Posted : November 23, 2021
Ministère de la Santé de la RDC
Médecins Sans Frontières, France
Coalition for Epidemic Preparedness Innovations
Janssen Vaccines & Prevention B.V.
Public Health England
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Brief Summary:
A single arm, open-label, non-randomized, interventional phase 3 study to measure safety and effectiveness of a heterologous, two dose preventative vaccine (Ad26. ZEBOV, MVA-BN®-Filo) against Ebola Virus Disease.

Condition or disease Intervention/treatment Phase
Ebola Virus Disease Biological: Ad26.ZEBOV, MVA-BN-Filo vaccine Phase 3

Detailed Description:

Ebola Virus Disease (EVD) is an acute, systemic, febrile syndrome caused by Ebola viruses. EVD has a case fatality ranging from 30% to 90% and spreads by direct contact with body fluids of symptomatic patients.

During the 2013-16 Ebola outbreak in Guinea, a Phase 3 cluster-randomised ring-vaccination trial using single-dose rVSV-ZEBOV-GP investigational vaccine reported 100% efficacy in protection against EVD. In 2016, the WHO Strategic Advisory Group of Experts (SAGE) on Immunization recommended the rapid deployment of rVSV-ZEBOV-GP in case of an EVD outbreak under an Expanded Access (compassionate use) protocol, with informed consent and Good Clinical Practice (GCP) compliance.

A new EVD outbreak started in North Kivu and Ituri provinces in the Democratic Republic of Congo in July 2018. Despite extensive control measures, including vaccination with rVSV-ZEBOV-GP in active outbreak areas, the outbreak has continued and WHO declared the outbreak a Public Health Emergency of International Concern on 17 July 2019. The ongoing outbreak has prompted consideration of additional vaccine candidates that might assist in preventing the spread of this infection to currently unaffected communities.

This study will investigate population-level vaccination with a two-dose prophylactic vaccine against Ebola, the Ad26.ZEBOV, MVA-BN-Filo vaccine that has been extensively studied in 11 previous safety and immunogenicity trials. This will be done by offering vaccination first to communities that neighbour the outbreak area or that are located on transport routes from the edge of the outbreak area to major centres like Goma.

In this study, approximately 500,000 healthy adults and children will be given the two-dose candidate vaccine regimen VAC52150 that consists of two vaccines, Ad26.ZEBOV and MVA-BN®-Filo, administered at an interval of 56 days (-14 day +28 day). Safety will be assessed in a safety subset of 1000 individuals and a pregnancy subset of up to 500 pregnant women will be followed to delivery. The first 100 infants born to these pregnant participants will be given a clinical examination at 3 months post-delivery. The study will estimate vaccine coverage of dose 1 and dose 2 overall and in different target groups and will also examine the knowledge and perceptions of persons eligible for large-scale delivery of a preventative Ebola vaccine with a two-dose vaccine strategy. The effectiveness of the vaccination on EVD will be determined through a test-negative case control study. The target sample size for the primary effectiveness evaluation is 110 laboratory-confirmed EVD cases.

An exploratory objective is to assess the immune response at before the second dose and 21 days after the second dose (MVN-BN-Filo) in a subgroup of 50 adults and 50 children who receive dose 2 beyond the recommended 56-day interval.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20426 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, open-label, non-randomized interventional trial of the two dose, Ad26.ZEBOV, MVA-BN-Filo Ebola preventative vaccine
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of a Heterologous, Two-dose Preventive Ebola Vaccine for Effectiveness and Safety in the Democratic Republic of the Congo
Actual Study Start Date : November 14, 2019
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : February 28, 2022

Arm Intervention/treatment
Experimental: Intervention arm
The vaccine Ad26.ZEBOV (5x10^10 viral particles (vp)) will be given as the first dose and the vaccine MVA-BN-Filo (1x10^8 infectious units (Inf U)) will be given as the second dose 56 (-14 day +28 day) days later.
Biological: Ad26.ZEBOV, MVA-BN-Filo vaccine

Ad26.ZEBOV: a monovalent vaccine expressing the full-length glycoprotein (GP) from Ebola virus (EBOV) Mayinga. The vaccine is produced in the human cell line PER.C6®.

MVA-mBN226B: further referred to as Modified Vaccinia Ankara (MVA)-BN®-Filo. This is a multivalent vaccine expressing the EBOV GP, the Sudan virus (SUDV) GP, the Marburg virus (MARV) Musoke GP, and the Taï Forest virus (TAFV, formerly known as Côte d'Ivoire ebolavirus) nucleoprotein (NP). The EBOV GP expressed by MVA BN Filo has 100% homology with the one expressed by Ad26.ZEBOV.

Primary Outcome Measures :
  1. Numbers and odds of vaccination status in Ebola Virus Diseases cases and in EVD-negative controls. [ Time Frame: Through study completion, an average of 2 years. ]
    Test negative case control study of 110 laboratory confirmed EVD cases matched to controls who test negative for EVD. Effectiveness is derived from the odds ratio for vaccination in cases compared to controls to calculate vaccine effectiveness.

Secondary Outcome Measures :
  1. Number and proportion of adults and children with solicited and unsolicited serious adverse events. [ Time Frame: From date of first vaccination to the one month post-dose 2 assessment of the last vaccinated participant. ]
    Data on SAEs within one month post-dose 2 that are considered related to vaccination with Ad26. ZEBOV, MVA-BN®-Filo vaccine in adults and children.

  2. Number and proportion of adults and children receiving dose 1. [ Time Frame: From date of first vaccination up to month 12. ]
    Vaccine uptake

  3. Number and proportion of adults and children receiving dose 2. [ Time Frame: From date of first vaccination up to month 12. ]
    Vaccine coverage

  4. Number of participants participating in in-depth interviews and focus group discussions [ Time Frame: Through to study completion at month 24. ]
    Focus group discussions and in-depth interviews on participant and community perceptions of the trial and on vaccine acceptability.

Other Outcome Measures:
  1. Samples collected for immunogenicity subset at 2 time points [ Time Frame: From date of dose 2 through to 21 days post-dose 2. ]
    Level of immunoglobulin G binding antibodies at dose 2 and 21 days post-dose 2

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Must provide a written or witnessed (if illiterate) informed consent form indicating that he or she understands the reasons for the study and is willing to participate in the study and be vaccinated. If less than 18 years old, must have a parent or guardian that is able to meet this criterion.
  2. Must be aged 1 year or older.
  3. Must be healthy in the investigator's clinical judgment as assessed on the day of vaccination.
  4. Must be willing to have a photograph taken.
  5. Participant must be available and willing to participate for duration of study visits and follow up.

Exclusion Criteria:

  1. Known history of Ebola virus disease.
  2. Has received any experimental Ebola vaccine less than one month prior to Visit 1.
  3. Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products, egg and egg proteins or gentamicin.
  4. Presence of acute illness (excluding minor illnesses such as mild diarrhea or mild upper respiratory tract infection) or temperature ≥38.0ºC at Visit 1 (dose 1 visit). Participants with such symptoms will be temporarily excluded from vaccination at that time but may be rescheduled for vaccination at a later date if feasible.
  5. Presence of significant conditions or clinically significant findings at the vaccination visit for which, in the opinion of the investigator, vaccination would not be in the best interest of the participant.
  6. History of recurrent generalized hives.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04152486

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Congo, The Democratic Republic of the
L'Institut National de Recherche Biomédicale RDC
Kinshasa, Congo, The Democratic Republic of the
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Ministère de la Santé de la RDC
Médecins Sans Frontières, France
Coalition for Epidemic Preparedness Innovations
Janssen Vaccines & Prevention B.V.
Public Health England
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Principal Investigator: Jean-Jacques Muyembe-Tamfum, MD, PhD L'Institut National de Recherche Biomédicale RDC
Principal Investigator: Daniel Bausch, MD, PhD London School of Hygiene and Tropical Medicine
Principal Investigator: Deborah Watson-Jones, MD, PhD London School of Hygiene and Tropical Medicine
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: London School of Hygiene and Tropical Medicine Identifier: NCT04152486    
Other Study ID Numbers: DRC-EB-001
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: November 23, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual level data (de-identified) that underlie results in a publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Six months to 60 months after publication of main trial results.
Access Criteria:

Access request to: (ORCID: 0000-0001-6247-1746) cc. Tansy (ORCID: 0000-0002-6110-014X) cc. (ORCID: 0000-0002-8148-120X)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Virus Diseases
Hemorrhagic Fever, Ebola
Hemorrhagic Fevers, Viral
RNA Virus Infections
Filoviridae Infections
Mononegavirales Infections
Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Antiviral Agents
Anti-Infective Agents