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Study to Evaluate the Immunogenicity and Safety of a Heterologous Vaccine Regimen Against Ebola (EBOVAC3DRC)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04186000
Recruitment Status : Recruiting
First Posted : December 4, 2019
Last Update Posted : January 18, 2020
Sponsor:
Collaborators:
Johnson & Johnson
Ace Africa
Innovative Medicines Initiative
Coalition for epidemic prepardness innovations
University of Kinshasa
Information provided by (Responsible Party):
Pierre Van Damme, Universiteit Antwerpen

Study Description
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Brief Summary:
This Phase 2 study aims to improve preparedness for future Ebola outbreaks by vaccination of a well-known population at risk, ie, a cohort of health care providers (HCP) (such as primary, emergency, and community health care workers) who may be exposed to Ebola in the event of a future outbreak in the Democratic Republic of the Congo (DRC). This study will enhance the immunogenicity database by investigating the kinetics of the humoral immune response. The study will contribute to the safety database (serious adverse events) for VAC52150 following a heterologous vaccine regimen with Ad26.ZEBOV as first vaccine followed by second dose with MVA-BN-Filo administered 56 days later (Day 57). Additionally, after randomization (1:1), a booster vaccination with Ad26.ZEBOV will be executed at 1 year post first dose or 2 years post first dose.

Condition or disease Intervention/treatment Phase
Ebola Virus Disease Biological: Ad26.ZEBOV vaccine Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All participants receive a heterologous vaccine regimen with Ad26.ZEBOV as first vaccine followed by second dose with MVA-BN-Filo administered 56 days later (Day 57). After randomization (1:1), a booster vaccination with Ad26.ZEBOV will be executed at 1 year post first dose or 2 years post first dose.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Open-label Phase 2 Study to Evaluate the Immunogenicity and Safety of a Prophylactic Vaccination of Health Care Providers by Administration of a Heterologous Vaccine Regimen Against Ebola in the Democratic Republic of the Congo
Actual Study Start Date : December 18, 2019
Estimated Primary Completion Date : July 18, 2022
Estimated Study Completion Date : December 18, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

Arms and Interventions
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Arm Intervention/treatment
Experimental: group 1
Booster vaccine with AD26.ZEBOV after 1 year
 Biological: Ad26.ZEBOV vaccine
The booster vaccination with Ad26.ZEBOV (5x10^10 vp, same dosage as during the first dose) will be given at 1 year after the first dose or 2 years post-first dose.
Experimental: group 2
Booster vaccine with AD26.ZEBOV after 2 years
 Biological: Ad26.ZEBOV vaccine
The booster vaccination with Ad26.ZEBOV (5x10^10 vp, same dosage as during the first dose) will be given at 1 year after the first dose or 2 years post-first dose.


Outcome Measures
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Primary Outcome Measures :
  1. Binding antibody responses post-dose 2 vaccination with MVA-BN-Filo [ Time Frame: 21 days post-dose 2 vaccination ]
    To assess binding antibody levels against the EBOV GP using FANG ELISA


Secondary Outcome Measures :
  1. Safety of a heterologous vaccine regimen utilizing Ad26.ZEBOV as dose 1, MVA-BN-Filo as dose 2 and Ad26.ZEBOV as booster dose 3 [ Time Frame: The entire clinical study for SAE reporting and until 7 days post booster for solicited local and system adverse events ]
    To assess serious adverse events (SAE) during the entire clinical study and to assess solicited local and systemic adverse events until 7 days post booster/dose 3 vaccination with Ad26.ZEBOV

  2. Binding antibody responses after booster vaccination with Ad26.ZEBOV [ Time Frame: 7 days post-booster vaccination ]
    To assess binding antibody levels against the EBOV GP using FANG ELISA


Eligibility Criteria
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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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The participant must pass the Test of Understanding (TOU).
  • Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study. In case the participant cannot read or write, the procedures must be explained and informed consent must be witnessed by a trusted literate third party not involved with the conduct of the study.
  • Participant must be a man or woman aged 18 years or older.
  • Participant must be a documented health care provider in DRC.
  • Participant must be healthy in the investigator's clinical judgment and on the basis of vital signs assessed at day 1 screening.
  • Before vaccination, a woman must be either:

Of childbearing potential and practicing (or intending to practice) a highly effective method of birth control consistent with local regulations and/or local culture regarding the use of birth control methods for participants in clinical studies, beginning at least 28 days prior to vaccination and during the study up to at least 3 months after the first (or only) vaccination (Ad26.ZEBOV) and 1 month after the MVA-BN-Filo vaccination (if applicable); and then starting again 14 days before the booster vaccination until 3 months after the booster vaccination.

OR Not of childbearing potential: postmenopausal (amenorrhea for at least 12 months without alternative medical cause); permanently sterilized (eg, bilateral tubal occlusion [which includes tubal ligation procedures as consistent with local regulations], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); OR otherwise be incapable of pregnancy.

  • Woman of childbearing potential must have a negative urine β-human chorionic gonadotropin (β-hCG) pregnancy test immediately prior to each study vaccine administration.
  • Participant must be available and willing to participate for the duration of the study.
  • Participant must be willing and able to comply with the protocol requirements, including the prohibitions and restrictions specified in Section 4.3.
  • Participant must be willing to provide verifiable identification.
  • Participant must have a means to be contacted.

Exclusion Criteria:

  • Known history of Ebola virus disease.
  • Having received any experimental candidate Ebola vaccine less than 3 months prior to the screening at the first visit.
  • Having received any experimental candidate Ad26-vaccine in the past. Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccines [eg, polysorbate 80, ethylenediaminetetraacetic acid (EDTA) or L-histidine for Ad26.ZEBOV vaccine; and tris (hydroxymethyl)-amino methane (THAM) for MVA BN-Filo vaccine]), including known allergy to egg, egg products and aminoglycosides.
  • Presence of acute illness (this does not include minor illnesses such as mild diarrhea or mild upper respiratory tract infection) or temperature ≥38.0ºC on Day 1. Participants with such symptoms will be excluded from enrollment at that time, but may be rescheduled for enrollment at a later date if feasible.
  • Pregnant or breastfeeding women, or women planning to become pregnant while enrolled in this study until at least 3 months after the Ad26.ZEBOV vaccination or 1 month after MVA-BN-Filo.
  • Presence of significant conditions or clinically significant findings at screening or vital signs for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the safety or well-being) or that could prevent, limit, or confound the protocol-specified assessments.
  • Major surgery (per the investigator's judgment) within the 4 weeks prior to screening, or planned major surgery during the study (from the start of screening onwards).
  • Post-organ and/or stem cell transplant whether or not with chronic immunosuppressive therapy.
  • Received an investigational drug or investigational vaccines or used an invasive investigational medical device within 3 months prior to screening, or current or planned participation in another clinical study during the study.
  • History of chronic urticaria (recurrent hives).
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04186000


Contacts
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Contact: Hypolite Mavoko Muhindo, Dr. 0994406532 ext 00243 hypomavoko@gmail.com
Contact: Pierre Van Damme, Prof. 032652130 ext 0032 pierre.vandamme@uantwerpen.be

Locations
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Congo, The Democratic Republic of the
Hôpital Général de Référence de Boende Recruiting
Boende, Province De La Tshuapa, Congo, The Democratic Republic of the
Contact: Hypolite Muhindo, PhD    0994406532 ext +243    hypomavoko@gmail.com   
Sponsors and Collaborators
Universiteit Antwerpen
Johnson & Johnson
Ace Africa
Innovative Medicines Initiative
Coalition for epidemic prepardness innovations
University of Kinshasa
Investigators
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Principal Investigator: Hypolite Mavoko Muhindo, Dr. University of Kinshasa, Tropical Medicine Department
More Information
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Additional Information:
IMVANEX suspension for injection. UK Summary of Product Characteristics.  This link exits the ClinicalTrials.gov site MVA-BN® (Modified Vaccinia Ankara - Bavarian Nordic).  This link exits the ClinicalTrials.gov site WHO Fact Sheet No103 Ebola Virus Disease 2014  This link exits the ClinicalTrials.gov site Meeting of the Strategic Advisory Group of Experts on immunization, October 2018  This link exits the ClinicalTrials.gov site

Publications of Results:

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Responsible Party: Pierre Van Damme, clinical professor, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT04186000    
Other Study ID Numbers: VAC52150EBL2007
EDMS-ERI-176345633 ( Other Identifier: EDMS )
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Pierre Van Damme, Universiteit Antwerpen:
Ad26.ZEBOV
MVA-BN-Filo
DRC
health care providers
Additional relevant MeSH terms:
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Hemorrhagic Fever, Ebola
Virus Diseases
Hemorrhagic Fevers, Viral
RNA Virus Infections
Filoviridae Infections
 Mononegavirales Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs