Ebola Virus DiseasePhase 3NCT03161366
Providing Additional Information on the Safety and Effectiveness of an Ebola Vaccine
A Phase 3 study testing rVSVΔG-ZEBOV-GP in people with Ebola Virus Disease, run by Epicentre at 2 sites in 2 countries.
Trial summary
Interventional, single arm, open-label, non-randomized, phase IIIb study to accumulate additional data on safety and effectiveness of one dose of rVSVΔG-ZEBOV-GP against Ebola virus disease. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Ebola Virus Disease
- What is being tested?
- rVSVΔG-ZEBOV-GP
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 May 2018to 30 Nov 2018
- Phase
- Phase 3
- 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 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Individuals aged 6 years or older will be enrolled in the study if they are a contact or contact of contact of a laboratory-confirmed Ebola virus disease case. Children aged between 1 and 6 years may also be enrolled in the study in case there is a confirmed contact with a laboratory-confirmed Ebola patient
- willing to accept weekly visits
- intending to remain in the study area for three months
- providing informed consent, and where applicable, assent
Who cannot join
- history of EVD (self-report or laboratory confirmed)
- history of having received other investigational research agents in the previous 28 days
- history of anaphylaxis to a vaccine or vaccine component (self-report)
- severe illness that makes the person bed-bound or requiring hospitalization at the time of the vaccination
- severe immunocompromised status
- history of having received immunosuppressant therapies that would substantially interfere with the mode of action of the Ebola vaccine in the previous 6 months
Show all 12Show fewer
- unwilling to accept weekly visits
- not intending to remain in the study area for three months
- informed consent or assent not provided
- any other condition in which, in the judgment of the investigator, would interfere with or serve as a contraindication to protocol adherence, or impair the subject or caregiver's ability to give informed consent, and where applicable, assent.
- fever above 38°C
- previous receipt of rVSVΔG-ZEBOV-GP in the last 3 years or at being part of another Ebola vaccine clinical trial.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Democratic Republic of the Congo1 site
Médecins Sans Frontières
Kinshasa
About this study
Official title: An Open-label, Single Arm Study to Provide Additional Information on Safety and Effectiveness of rVSVΔG-ZEBOV-GP
Interventional, single arm, open-label, non-randomized, phase IIIb study to accumulate additional data on safety and effectiveness of one dose of rVSVΔG-ZEBOV-GP against Ebola virus disease.
Read the detailed description
Ebola Virus Disease remains ill-known by populations, creating fear and mistrust, is highly contagious, requiring strict isolation measures and with only supportive therapy available that has limited impact on case-fatality which remains high (30 -80%).1 Among vaccines in development, the rVSVΔG-ZEBOV-GP vaccine has given the most promising results in terms of efficacy and safety having been evaluated now in more than 10,000 individuals.
Ring vaccination is a known strategy to control epidemics with specific transmission chains and has been successfully implemented to eradicate smallpox. Ring vaccination enhances standard public health measures of contact tracing, isolation, and community engagement and could be effective when such measures are in place. Building on the interim results of the Ebola ça Suffit trial, there is a need for continued access to a vaccine of which available results suggest that it is safe and likely efficacious against EVD. Although only isolated cases have been reported in Guinea, Sierra Leone and Liberia in 2016, 10 the risk of resurgence or of continued isolated cases in West Africa remains. Moreover, a new outbreak with Ebola Zaïre could start any moment in any of the countries where previous outbreaks occurred as in for example Democratic Republic of Congo and Uganda.
However, the unusual design of the ring trial and the decision to abandon the control group because of strong evidence that the vaccine prevented disease means there may not be enough data to ensure approval from regulatory agencies. Therefore, additional information is still required to consolidate knowledge on the rVSVΔG-ZEBOV-GP vaccine to support regulatory approval and licensure for future access. Additional information is also needed on ring vaccination and contextual adaptations to this approach to ensure its feasibility and effectiveness in the control of Ebola outbreaks in potentially diverse contexts.
- Conditions
- Ebola Virus Disease
- Being tested
- rVSVΔG-ZEBOV-GP
- Keywords
- Ebola Zaire Outbreak, Safety of rVSVΔG-ZEBOV-GP vaccine, Effectiveness of rVSVΔG-ZEBOV-GP vaccine
- 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.
rVSVΔG-ZEBOV-GPBiological
Ring vaccination with vaccination of contacts and contacts of contacts after laboratory confirmation of one Ebola Zaire case
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Vaccination of contacts and contacts of contacts of a confirmed Ebola Zaire case with one dose of rVSVΔG-ZEBOV-GP (≥ 2x10^7 PFU) Receives: Biological: rVSVΔG-ZEBOV-GP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence
Occurrence of Ebola Zaire cases amongst contacts and contacts of contacts
Measured: 84 days after vaccination
Secondary outcomes (1)
Assessment of Adverse and Serious Adverse Events
Safety of a single dose of rVSVΔG-ZEBOV-GP
Measured: 84 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start28 May 2018
- Primary completion14 Jul 2018
- Study completion30 Nov 2018
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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional, single arm, open-label, non-randomized
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- Medecins Sans Frontieres, Netherlands
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161366
- Sponsor's protocol ID
- V920-01
- Status last verified
- Dec 2018
- First submitted
- 18 May 2017
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be done following MSFdata sharing policy
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Arm Study to Provide Additional Information on Safety and Effectiveness of rVSVΔG-ZEBOV-GP
- ClinicalTrials.gov ID
- NCT03161366
- Acronym / sponsor ID
- V920-01
- Conditions
- Ebola Virus Disease
- Keywords
- Ebola Zaire Outbreak, Safety of rVSVΔG-ZEBOV-GP vaccine, Effectiveness of rVSVΔG-ZEBOV-GP vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- Medecins Sans Frontieres, Netherlands
- Study start
- 28 May 2018 (actual)
- Primary completion
- 14 Jul 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 19 May 2017 (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.
Interventional, single arm, open-label, non-randomized, phase IIIb study to accumulate additional data on safety and effectiveness of one dose of rVSVΔG-ZEBOV-GP against Ebola virus disease.
Detailed description
Ebola Virus Disease remains ill-known by populations, creating fear and mistrust, is highly contagious, requiring strict isolation measures and with only supportive therapy available that has limited impact on case-fatality which remains high (30 -80%).1 Among vaccines in development, the rVSVΔG-ZEBOV-GP vaccine has given the most promising results in terms of efficacy and safety having been evaluated now in more than 10,000 individuals.
Ring vaccination is a known strategy to control epidemics with specific transmission chains and has been successfully implemented to eradicate smallpox. Ring vaccination enhances standard public health measures of contact tracing, isolation, and community engagement and could be effective when such measures are in place. Building on the interim results of the Ebola ça Suffit trial, there is a need for continued access to a vaccine of which available results suggest that it is safe and likely efficacious against EVD. Although only isolated cases have been reported in Guinea, Sierra Leone and Liberia in 2016, 10 the risk of resurgence or of continued isolated cases in West Africa remains. Moreover, a new outbreak with Ebola Zaïre could start any moment in any of the countries where previous outbreaks occurred as in for example Democratic Republic of Congo and Uganda.
However, the unusual design of the ring trial and the decision to abandon the control group because of strong evidence that the vaccine prevented disease means there may not be enough data to ensure approval from regulatory agencies. Therefore, additional information is still required to consolidate knowledge on the rVSVΔG-ZEBOV-GP vaccine to support regulatory approval and licensure for future access. Additional information is also needed on ring vaccination and contextual adaptations to this approach to ensure its feasibility and effectiveness in the control of Ebola outbreaks in potentially diverse contexts.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional, single arm, open-label, non-randomized
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Biological: rVSVΔG-ZEBOV-GPVaccination of contacts and contacts of contacts of a confirmed Ebola Zaire case with one dose of rVSVΔG-ZEBOV-GP (≥ 2x10^7 PFU) |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals aged 6 years or older will be enrolled in the study if they are a contact or contact of contact of a laboratory-confirmed Ebola virus disease case. Children aged between 1 and 6 years may also be enrolled in the study in case there is a confirmed contact with a laboratory-confirmed Ebola patient
- willing to accept weekly visits
- intending to remain in the study area for three months
- providing informed consent, and where applicable, assent
Key exclusion criteria (12 listed)
- history of EVD (self-report or laboratory confirmed)
- history of having received other investigational research agents in the previous 28 days
- history of anaphylaxis to a vaccine or vaccine component (self-report)
- severe illness that makes the person bed-bound or requiring hospitalization at the time of the vaccination
- severe immunocompromised status
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 |
|---|---|---|
| rVSVΔG-ZEBOV-GPRing vaccination with vaccination of contacts and contacts of contacts after laboratory confirmation of one Ebola Zaire case | Biological | Single arm |
Primary outcome
Cumulative incidence
Time frame: 84 days after vaccination
Occurrence of Ebola Zaire cases amongst contacts and contacts of contacts
1 secondary outcome
Assessment of Adverse and Serious Adverse Events
Time frame: 84 days after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Individual participant dataSharing planned: Undecided. To be done following MSFdata sharing policy
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rVSVΔG-ZEBOV-GP in people with Ebola Virus Disease, run by Epicentre at 2 sites in 2 countries.
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Democratic Republic of the Congo, Uganda. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence (time frame: 84 days after vaccination). 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 19 Dec 2018.