Prophylaxis Vaccine Antibodies Ebola

NCT ID: NCT04822376

Last Updated: 2021-10-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-17
• Study Completion Date: 2022-04-30

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.

Conditions

Ebola Virus Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

High risk arm

Mabs at day 0 and vaccine at week 6

Group Type: EXPERIMENTAL

ansuvimab

Intervention Type: DRUG

Human monoclonal antibody to Zaire strain GP (EBOV GP)

Ervebo

Intervention Type: BIOLOGICAL

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)

High risk arm (Immunological ancillary study)

Mabs at day 0 and vaccine at week 6

Group Type: EXPERIMENTAL

ansuvimab

Intervention Type: DRUG

Human monoclonal antibody to Zaire strain GP (EBOV GP)

Ervebo

Intervention Type: BIOLOGICAL

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)

Control arm (Immunological ancillary study)

Vaccine at day 0 for contacts eligible for vaccination

Group Type: ACTIVE_COMPARATOR

Ervebo

Intervention Type: BIOLOGICAL

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)

Interventions

ansuvimab

Human monoclonal antibody to Zaire strain GP (EBOV GP)

Intervention Type: DRUG

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)

Intervention Type: BIOLOGICAL

Other Intervention Names

mab114; VSV-ZEBOV

Eligibility Criteria

Inclusion Criteria

• 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.

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:

• HIV positive;
• Pregnant women.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre de Traitement Ebola de N'Zerekore

N'Zerekore, , Guinea

Countries

Guinea

Central Contacts

Marie Jaspard, MD

Role: CONTACT

marie.jaspard@coral.alima.ngo

Facility Contacts

Sakoba Keita, MD

Role: primary

sakoba54@gmail.com

+224 624510581

Other Identifiers

ANRS 0006S

Identifier Type: -

Identifier Source: org_study_id