NCT04152486

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20,426

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
9 days until next milestone

Study Start

First participant enrolled

November 14, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

November 23, 2021

Status Verified

June 1, 2021

Enrollment Period

2.2 years

First QC Date

October 25, 2019

Last Update Submit

November 15, 2021

Conditions

Ebola Virus Disease

Outcome Measures

Primary Outcomes (1)

  • Numbers and odds of vaccination status in Ebola Virus Diseases cases and in EVD-negative controls.

    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.

    Through study completion, an average of 2 years.

Secondary Outcomes (4)

  • Number and proportion of adults and children with solicited and unsolicited serious adverse events.

    From date of first vaccination to the one month post-dose 2 assessment of the last vaccinated participant.

  • Number and proportion of adults and children receiving dose 1.

    From date of first vaccination up to month 12.

  • Number and proportion of adults and children receiving dose 2.

    From date of first vaccination up to month 12.

  • Number of participants participating in in-depth interviews and focus group discussions

    Through to study completion at month 24.

Other Outcomes (1)

  • Samples collected for immunogenicity subset at 2 time points

    From date of dose 2 through to 21 days post-dose 2.

Study Arms (1)

Intervention arm

EXPERIMENTAL

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

Interventions

Ad26.ZEBOV, MVA-BN-Filo vaccineBIOLOGICAL

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.

Intervention arm

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Must be aged 1 year or older.
  • Must be healthy in the investigator's clinical judgment as assessed on the day of vaccination.
  • Must be willing to have a photograph taken.
  • Participant must be available and willing to participate for duration of study visits and follow up.

You may not qualify if:

  • Known history of Ebola virus disease.
  • Has received any experimental Ebola vaccine less than one month prior to Visit 1.
  • Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products, egg and egg proteins or gentamicin.
  • 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.
  • 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.
  • History of recurrent generalized hives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

L'Institut National de Recherche Biomédicale RDC

Kinshasa, Democratic Republic of the Congo

Location

Related Publications (1)

  • Watson-Jones D, Kavunga-Membo H, Grais RF, Ahuka S, Roberts N, Edmunds WJ, Choi EM, Roberts CH, Edwards T, Camacho A, Lees S, Leyssen M, Spiessens B, Luhn K, Douoguih M, Hatchett R, Bausch DG, Muyembe JJ; DRC-EB-001 protocol writing team. Protocol for a phase 3 trial to evaluate the effectiveness and safety of a heterologous, two-dose vaccine for Ebola virus disease in the Democratic Republic of the Congo. BMJ Open. 2022 Mar 8;12(3):e055596. doi: 10.1136/bmjopen-2021-055596.

    PMID: 35260458DERIVED

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, ViralRNA Virus InfectionsVirus DiseasesInfectionsFiloviridae InfectionsMononegavirales Infections

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Single arm, open-label, non-randomized interventional trial of the two dose, Ad26.ZEBOV, MVA-BN-Filo Ebola preventative vaccine
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2019

First Posted

November 5, 2019

Study Start

November 14, 2019

Primary Completion

January 31, 2022

Study Completion

February 28, 2022

Last Updated

November 23, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

Individual level data (de-identified) that underlie results in a publication.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Six months to 60 months after publication of main trial results.
Access Criteria
Access request to: Deborah.Watson-Jones@lshtm.ac.uk (ORCID: 0000-0001-6247-1746) cc. Tansy Edwards@lshtm.ac.uk (ORCID: 0000-0002-6110-014X) cc. Edward.Choi@lshtm.ac.uk (ORCID: 0000-0002-8148-120X)

Locations

DE(1)