Prophylaxis Vaccine Antibodies Ebola | NCT04822376

Studies
Prophylaxis Vaccine Antibodies Ebola

NCT04822376

Sponsor

ANRS, Emerging Infectious Diseases

Status

Unknown status

Last Update Posted

Oct 15, 2021Actual

Enrollment

250Estimated

Phase

Phase 2

Conditions

Ebola Virus Disease

Interventions

ansuvimab
Ervebo

Countries

Guinea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 17, 2021Estimated

Primary Completion Date

Apr 2022Estimated

Completion Date

Apr 2022Estimated

First Submitted Date

Mar 26, 2021

First Submission Date that Met QC Criteria

Mar 26, 2021

First Posted Date

Mar 30, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2021

Last Update Posted Date

Oct 15, 2021Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ansuvimab	Drug	Human monoclonal antibody to Zaire strain GP (EBOV GP)	High risk arm High risk arm (Immunological ancillary study)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Tolerance	Estimating adverse effects	Day 7 post-PEP and day 7 post-vaccination
Lost of follow-up	Lost of follow-up rate	Week 6

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Marie Jaspard, MD	Contact			marie.jaspard@coral.alima.ngo

ID	Term
D019142	Hemorrhagic Fever, Ebola

ID	Term
D006482	Hemorrhagic Fevers, Viral
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections

ID	Term
C000711947	ansuvimab

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.