Prophylaxis Vaccine Antibodies Ebola

NCT04822376 | Unknown Phase 2 DMC

• 1 other identifier: ANRS 0006S
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Efficacy

  Proportion of participants with negative RT-PCR

  Week 3

• Immunological ancillary study

  Anti-GP IgG level (FANG reference technique)

  6 months after vaccination

Secondary Outcomes (4)

• Tolerance

  Day 7 post-PEP and day 7 post-vaccination

• Lost of follow-up

  Week 6

• Humoral immune response

  1 and 3 months after vaccination

• Neutralizing antibodies

  1, 3 and 6 months after vaccination

Study Arms (3)

High risk arm

EXPERIMENTAL

Mabs at day 0 and vaccine at week 6

Drug: ansuvimab; Biological: Ervebo

High risk arm (Immunological ancillary study)

EXPERIMENTAL

Mabs at day 0 and vaccine at week 6

Drug: ansuvimab; Biological: Ervebo

Control arm (Immunological ancillary study)

ACTIVE COMPARATOR

Vaccine at day 0 for contacts eligible for vaccination

Biological: Ervebo

Interventions

ansuvimab DRUG

Human monoclonal antibody to Zaire strain GP (EBOV GP)

Also known as: mab114

High risk arm; High risk arm (Immunological ancillary study)

Ervebo 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)

Also known as: VSV-ZEBOV

Control arm (Immunological ancillary study); High risk arm; High risk arm (Immunological ancillary study)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have had, within the previous 72 hours, a high-risk contact with an Ebola patient confirmed by RT-PCR;
• 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.
• Have a history of EVD (self-report);
• Have been vaccinated with ERVEBO prior to the start of the study;
• 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:
• 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.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (1)

Centre de Traitement Ebola de N'Zerekore

N'Zerekore, Guinea

Location

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Interventions

ansuvimab

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Central Study Contacts

Marie Jaspard, MD

CONTACT

marie.jaspard@coral.alima.ngo

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 30, 2021
• Study Start: October 17, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: October 15, 2021

Record last verified: 2021-10

Locations

GU (1)