An Open-label, Single Arm Study to Provide Additional Information on Safety and Effectiveness of rVSVΔG-ZEBOV-GP

Providing Additional Information on the Safety and Effectiveness of an Ebola Vaccine



Sponsors


Source

Epicentre

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief 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.

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.

Overall Status

Not yet recruiting

Start Date

2017-06-01

Completion Date

2017-12-31

Primary Completion Date

2017-09-01

Phase

Phase 3

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Cumulative incidence
84 days after vaccination

Secondary Outcome

Measure

Time Frame

Assessment of Adverse and Serious Adverse Events
84 days after vaccination

Enrollment

500

Condition


Intervention

Intervention Type

Biological

Intervention Name


Description

Ring vaccination with vaccination of contacts and contacts of contacts after laboratory confirmation of one Ebola Zaire case

Arm Group Label

Single arm


Eligibility

Criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- 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.

Gender

All

Minimum Age

1 Year

Maximum Age

N/A

Healthy Volunteers

Accepts Healthy Volunteers


Overall Contact

Last Name

Rebecca F GRAIS, PhD

Phone

+33140215475

Email

[email protected]


Verification Date

2017-05-01

Lastchanged Date

2017-05-18

Firstreceived Date

2017-05-18

Responsible Party

Responsible Party Type

Sponsor


Keywords


Has Expanded Access

No

Condition Browse


Number Of Arms

1

Intervention Browse

Mesh Term

Vaccines


Arm Group

Arm Group Label

Single arm

Arm Group Type

Experimental

Description

Vaccination of contacts and contacts of contacts of a confirmed Ebola Zaire case with one dose of rVSVΔG-ZEBOV-GP (≥ 2x10^7 PFU)


Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Micaela SERAFINI, MD

Phone

+41228498250

Email

[email protected]


Patient Data

Sharing Ipd

Undecided

Ipd Description

To be done following MSFdata sharing policy


Firstreceived Results Disposition Date

N/A

Study Design Info

Intervention Model

Single Group Assignment

Intervention Model Description

Interventional, single arm, open-label, non-randomized

Primary Purpose

Prevention

Masking

No masking



ClinicalTrials.gov processed this data on May 19, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



© 2017 ICH GCP