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Prophylaxis Vaccine Antibodies Ebola (PROVAE)

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ClinicalTrials.gov Identifier: NCT04822376
Recruitment Status : Not yet recruiting
First Posted : March 30, 2021
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
ANRS, Emerging Infectious Diseases

Brief Summary:
  • Three measures are currently being implemented to control Ebola outbreaks:

    • Monitoring of contacts
    • Isolation and treatment of sick people
    • Vaccination of the population in high-risk areas.
  • In contacts with high viral exposure and therefore a high risk of incubation and rapid expression of infection, the r-VSV-ZEBOV vaccine does not provide adequate protection because vaccine antibody production is effective 6 to 10 days after administration.
  • Specific monoclonal antibodies (Mab) from the Regeneron and mAb114 research specialties have been shown to be effective in reducing mortality in patients with Ebola virus disease (EVD).
  • Their use in a single parenteral administration and good tolerability make them candidates for use in post-exposure prophylaxis (PEP) in individuals at high risk of viral exposure.
  • A comprehensive strategy for the protection of high-risk contacts must therefore be implemented, including the vaccine and the Mabs, to ensure both immediate and prolonged protection. Indeed, the efficacy of the vaccine is likely to be diminished when co-administered with Mabs, as both strategies share the same viral target (the GP envelope glycoprotein) and the vaccine is replicative (and therefore may be inhibited by Mabs).

PROVAE aim to evaluate the effectiveness of a comprehensive strategy to prevent transmission of MVE in contacts at high risk of infection, including (i) post-exposure prophylaxis with Mabs and (ii) vaccination with r-VSV-ZEBOV.


Condition or disease Intervention/treatment Phase
Ebola Virus Disease Drug: ansuvimab Biological: Ervebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:

Efficacy trial : Exploratory, non-comparative, unblinded trial with Mab at D0 and vaccine at W6.

Immunological ancillary study : Exploratory, controlled, comparative, non-randomized, 2-group, unblinded study comparing Mab at D0 and vaccine at W6 for high-risk contacts with vaccine at D0 for vaccinated contacts.

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase IIa Pilot Study Evaluating the Efficacy of a Monoclonal Antibody and Vaccine-based Post-exposure Prophylaxis Strategy in High-risk Contact Cases of Ebola Virus Disease Infection
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

Arm Intervention/treatment
Experimental: High risk arm
Mabs at day 0 and vaccine at week 6
Drug: ansuvimab
Human monoclonal antibody to Zaire strain GP (EBOV GP)
Other Name: mab114

Biological: Ervebo
Ebola Zaire vaccine (rVSV∆G-ZEBOV-GP, live, attenuated) ≥ 72 million PFU, composed of the Indiana strain of recombinant vesicular stomatitis virus (rVSV) with a deletion of the envelope glycoprotein (G) of VSV replaced by the surface glycoprotein (GP) of the Kikwit 1995 strain of Ebola virus Zaire (ZEBOV)
Other Name: VSV-ZEBOV

Experimental: High risk arm (Immunological ancillary study)
Mabs at day 0 and vaccine at week 6
Drug: ansuvimab
Human monoclonal antibody to Zaire strain GP (EBOV GP)
Other Name: mab114

Biological: Ervebo
Ebola Zaire vaccine (rVSV∆G-ZEBOV-GP, live, attenuated) ≥ 72 million PFU, composed of the Indiana strain of recombinant vesicular stomatitis virus (rVSV) with a deletion of the envelope glycoprotein (G) of VSV replaced by the surface glycoprotein (GP) of the Kikwit 1995 strain of Ebola virus Zaire (ZEBOV)
Other Name: VSV-ZEBOV

Active Comparator: Control arm (Immunological ancillary study)
Vaccine at day 0 for contacts eligible for vaccination
Biological: Ervebo
Ebola Zaire vaccine (rVSV∆G-ZEBOV-GP, live, attenuated) ≥ 72 million PFU, composed of the Indiana strain of recombinant vesicular stomatitis virus (rVSV) with a deletion of the envelope glycoprotein (G) of VSV replaced by the surface glycoprotein (GP) of the Kikwit 1995 strain of Ebola virus Zaire (ZEBOV)
Other Name: VSV-ZEBOV




Primary Outcome Measures :
  1. Efficacy [ Time Frame: Week 3 ]
    Proportion of participants with negative RT-PCR

  2. Immunological ancillary study [ Time Frame: 6 months after vaccination ]
    Anti-GP IgG level (FANG reference technique)


Secondary Outcome Measures :
  1. Tolerance [ Time Frame: Day 7 post-PEP and day 7 post-vaccination ]
    Estimating adverse effects

  2. Lost of follow-up [ Time Frame: Week 6 ]
    Lost of follow-up rate

  3. Humoral immune response [ Time Frame: 1 and 3 months after vaccination ]
    Anti-GP IgG level (FANG reference technique)

  4. Neutralizing antibodies [ Time Frame: 1, 3 and 6 months after vaccination ]
    Neutralizing antibodies level



Information from the National Library of Medicine

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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

The inclusion criteria for the efficacy trial are:

  • Have had, within the previous 72 hours, a high-risk contact with an Ebola patient confirmed by RT-PCR;
  • Be 18 years of age or older at the time of inclusion;
  • Have no symptoms of EVD;
  • Give consent to participate in the efficacy trial;
  • Agree not to participate in any other therapeutic or vaccine study until the end of the trial follow-up.

The criteria for non-inclusion in the efficacy trial are:

  • Have a history of EVD (self-report);
  • Have been vaccinated with ERVEBO prior to the start of the study;
  • Have participated in another therapeutic or vaccine study within 15 days prior to inclusion.

Inclusion criteria for the immunology ancillary study are:

High Risk Arm:

  • Be included in the efficacy trial;
  • Be available for extended follow-up as specified in the protocol;
  • Specifically consent to the immunology ancillary study.

Control arm:

  • Be 18 years of age or older at the time of inclusion;
  • Have no symptoms of EVD;
  • Eligible for ERVEBO vaccination according to national program criteria;
  • Be available for extended follow-up as specified in the protocol;
  • Consent specifically for the ancillary immunology study.

The criteria for non-inclusion in the immunologic ancillary study are:

  • All efficacy trial non-inclusion criteria;
  • HIV positive;
  • Pregnant women.

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): NCT04822376


Contacts
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Contact: Marie Jaspard, MD marie.jaspard@coral.alima.ngo

Locations
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Guinea
Centre de Traitement Ebola de N'Zerekore
N'Zerekore, Guinea
Contact: Sakoba Keita, MD    +224 624510581    sakoba54@gmail.com   
Sponsors and Collaborators
ANRS, Emerging Infectious Diseases
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Responsible Party: ANRS, Emerging Infectious Diseases
ClinicalTrials.gov Identifier: NCT04822376    
Other Study ID Numbers: ANRS0006S
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021

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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
Additional relevant MeSH terms:
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Virus Diseases
Hemorrhagic Fever, Ebola
Hemorrhagic Fevers, Viral
RNA Virus Infections
Filoviridae Infections
Mononegavirales Infections