Prophylaxis Vaccine Antibodies Ebola

Ebola Virus Disease Clinical Trial

— PROVAE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04822376
• Other study ID #: ANRS 0006S
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 17, 2021
• Est. completion date: April 2022

Study information

• Verified date: October 2021
• Source: ANRS, Emerging Infectious Diseases
• Contact: Marie Jaspard, MD
• Email: marie.jaspard[@]coral.alima.ngo
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ebola Virus Disease
• Hemorrhagic Fever, Ebola
• Virus Diseases

Intervention

Drug:
• ansuvimab
Human monoclonal antibody to Zaire strain GP (EBOV GP)

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)

Locations

Country	Name	City	State
Guinea	Centre de Traitement Ebola de N'Zerekore	N'Zerekore

Sponsors (1)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases

Country where clinical trial is conducted

Guinea, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	Proportion of participants with negative RT-PCR	Week 3
Primary	Immunological ancillary study	Anti-GP IgG level (FANG reference technique)	6 months after vaccination
Secondary	Tolerance	Estimating adverse effects	Day 7 post-PEP and day 7 post-vaccination
Secondary	Lost of follow-up	Lost of follow-up rate	Week 6
Secondary	Humoral immune response	Anti-GP IgG level (FANG reference technique)	1 and 3 months after vaccination
Secondary	Neutralizing antibodies	Neutralizing antibodies level	1, 3 and 6 months after vaccination