Status unknownNCT04822376PROVAEUpdated Oct 15, 2021

Prophylaxis Vaccine Antibodies Ebola

A Phase 2 interventional study of ansuvimab and Ervebo in Ebola Virus Disease, sponsored by ANRS, Emerging Infectious Diseases. Status unknown at 1 site in Guinea. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-15.

Sponsored by ANRS, Emerging Infectious Diseases · Phase 2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Phase 2
Study type: Interventional
Enrollment: 250
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study 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 studied

Ebola Virus Disease

Browse trials for

Hemorrhagic Fever, Ebola 104

In context

Hemorrhagic Fever, Ebola

104 studies on the registry are indexed under Hemorrhagic Fever, Ebola; 13 are open to participants now.

This study's planned enrollment of 250 is above the median of 94 across 81 interventional studies indexed under Hemorrhagic Fever, Ebola.

Browse Hemorrhagic Fever, Ebola studies →

Lead sponsor

ANRS, Emerging Infectious Diseases is the lead sponsor of 215 studies on the registry; 38 are open to participants now.

Browse ANRS, Emerging Infectious Diseases studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

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;
positive;
Pregnant women.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 250 participants (estimated)

Study arms

Experimental
High risk arm
Mabs at day 0 and vaccine at week 6
Drug: ansuvimab · Biological: Ervebo
Experimental
High risk arm (Immunological ancillary study)
Mabs at day 0 and vaccine at week 6
Drug: ansuvimab · Biological: Ervebo
Active comparator
Control arm (Immunological ancillary study)
Vaccine at day 0 for contacts eligible for vaccination
Biological: Ervebo

Interventions

Drugansuvimab
Human monoclonal antibody to Zaire strain GP (EBOV GP)
Also known as: mab114
BiologicalErvebo
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

What researchers measure

Primary outcomes

Efficacy
Proportion of participants with negative RT-PCR
Time frame: Week 3
Immunological ancillary study
Anti-GP IgG level (FANG reference technique)
Time frame: 6 months after vaccination

Secondary outcomes

Tolerance
Estimating adverse effects
Time frame: Day 7 post-PEP and day 7 post-vaccination
Lost of follow-up
Lost of follow-up rate
Time frame: Week 6
Humoral immune response
Anti-GP IgG level (FANG reference technique)
Time frame: 1 and 3 months after vaccination
Neutralizing antibodies
Neutralizing antibodies level
Time frame: 1, 3 and 6 months after vaccination

Study locations

1 site

Centre de Traitement Ebola de N'Zerekore
N'Zerekore, Guinea
- Sakoba Keita, MD · Contact · sakoba54@gmail.com · +224 624510581

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2021; primary completion for Apr 2022, 6 months later.

Of 13 phase 2 interventional studies under Hemorrhagic Fever, Ebola, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 39. This study's planned 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 26, 2021
First posted: Mar 30, 2021
StartEst.: Oct 17, 2021
Primary completionEst.: Apr 2022
CompletionEst.: Apr 2022
Last update: Oct 15, 2021

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Oct 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04822376
Lead sponsor: ANRS, Emerging Infectious Diseases
Responsible party: Sponsor
First posted: Mar 30, 2021
Start date: Oct 17, 2021 (estimated)
Primary completion: Apr 2022 (estimated)
Completion: Apr 2022 (estimated)
Last update: Oct 15, 2021

Study contacts

Marie Jaspard, MD

Contact

marie.jaspard@coral.alima.ngo

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Ansuvimab

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