Ebola Virus DiseasePhase 2PROVAENCT04822376
Prophylaxis Vaccine Antibodies Ebola
A Phase 2 study testing ansuvimab and Ervebo in people with Ebola Virus Disease, run by ANRS, Emerging Infectious Diseases at 1 site in Guinea.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ebola Virus Disease
- What is being tested?
- ansuvimab and Ervebo
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteGuinea
- Study dates
- 17 Oct 2021to Apr 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Marie Jaspard, MD contact
Guinea1 site
Centre de Traitement Ebola de N'Zerekore
N'Zerekore
Sakoba Keita, MD, +224 624510581, sakoba54@gmail.com
About this study
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
- 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
- Being tested
- ansuvimab, Ervebo
- Medical subject headings
- Hemorrhagic Fever, Ebola
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ansuvimabDrug
Also called mab114
Human monoclonal antibody to Zaire strain GP (EBOV GP)
ErveboBiological
Also called VSV-ZEBOV
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)
| Study group | Role | What they receive |
|---|---|---|
| High risk arm | Experimental | Mabs at day 0 and vaccine at week 6 Receives: Drug: ansuvimab; Biological: Ervebo |
| High risk arm (Immunological ancillary study) | Experimental | Mabs at day 0 and vaccine at week 6 Receives: Drug: ansuvimab; Biological: Ervebo |
| Control arm (Immunological ancillary study) | Active comparator | Vaccine at day 0 for contacts eligible for vaccination Receives: Biological: Ervebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Proportion of participants with negative RT-PCR
Measured: Week 3
Immunological ancillary study
Anti-GP IgG level (FANG reference technique)
Measured: 6 months after vaccination
Secondary outcomes (4)
Tolerance
Estimating adverse effects
Measured: Day 7 post-PEP and day 7 post-vaccination
Lost of follow-up
Lost of follow-up rate
Measured: Week 6
Humoral immune response
Anti-GP IgG level (FANG reference technique)
Measured: 1 and 3 months after vaccination
Neutralizing antibodies
Neutralizing antibodies level
Measured: 1, 3 and 6 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start17 Oct 2021 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ebola Virus DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822376
- Sponsor's protocol ID
- ANRS 0006S
- Acronym
- PROVAE
- Status last verified
- Oct 2021
- First submitted
- 26 Mar 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04822376
- Acronym / sponsor ID
- PROVAE / ANRS 0006S
- Conditions
- Ebola Virus Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- 17 Oct 2021 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| High risk arm | Experimental | Drug: ansuvimab, Biological: ErveboMabs at day 0 and vaccine at week 6 |
| High risk arm (Immunological ancillary study) | Experimental | Drug: ansuvimab, Biological: ErveboMabs at day 0 and vaccine at week 6 |
| Control arm (Immunological ancillary study) | Active comparator | Biological: ErveboVaccine at day 0 for contacts eligible for vaccination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Be included in the efficacy trial;
- Be available for extended follow-up as specified in the protocol;
- Specifically consent to the immunology ancillary study.
- Be 18 years of age or older at the time of inclusion;
- Have no symptoms of EVD;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ansuvimabAlso: mab114Human monoclonal antibody to Zaire strain GP (EBOV GP) | Drug | High risk arm, High risk arm (Immunological ancillary study) |
| ErveboAlso: VSV-ZEBOVEbola 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) | Biological | Control arm (Immunological ancillary study), High risk arm, High risk arm (Immunological ancillary study) |
Primary outcome
Efficacy
Time frame: Week 3
Proportion of participants with negative RT-PCR
Immunological ancillary study
Time frame: 6 months after vaccination
Anti-GP IgG level (FANG reference technique)
4 secondary outcomes
Tolerance
Time frame: Day 7 post-PEP and day 7 post-vaccination
Lost of follow-up
Time frame: Week 6
Humoral immune response
Time frame: 1 and 3 months after vaccination
Neutralizing antibodies
Time frame: 1, 3 and 6 months after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Jaspard, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ansuvimab and Ervebo in people with Ebola Virus Disease, run by ANRS, Emerging Infectious Diseases at 1 site in Guinea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guinea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Jaspard, MD (marie.jaspard@coral.alima.ngo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: Week 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.