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Virus Therapy

Ebola Vaccine Immunology

Phase 2

Recruiting

Led By Nadine Rouphael, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Received immunoglobulins and/or any blood products within 120 days prior to study vaccination

Received any Ebola vaccines or have history of Ebola Virus Disease (EVD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 29, day 366

Awards & highlights

No Placebo-Only Group

Summary

This trial will test an Ebola vaccine on 30 healthy adults. Blood & tissue samples will be taken before & after to see how the body responds.

Who is the study for?

Healthy adults who can consent, agree to use contraception, minimize exposure of bodily fluids to others for at least 14 days post-vaccination, and avoid blood donation for 56 days. Excluded are those with acute or chronic diseases needing treatment, substance abuse issues, immunocompromising conditions or treatments within the past 6 months, pregnancy/breastfeeding women, known allergies to vaccine components.

What is being tested?

The trial is testing a single dose of an Ebola vaccine (rVSV∆G-ZEBOV-GP) in 30 participants. It involves collecting blood samples and other biopsies before and after vaccination to study immune responses over time in different body tissues.

What are the potential side effects?

Potential side effects aren't specified here but could include typical vaccine reactions such as soreness at injection site, fever, fatigue or allergic reactions. Since it's an investigational vaccine more unique side effects may be possible.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not received blood products or immunoglobulins in the last 120 days.

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I have received an Ebola vaccine or had Ebola before.

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I haven't taken any experimental drugs within the last 28 days or 5 half-lives, whichever is longer.

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I have not had a fever or any signs of infection in the last 3 days.

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I have a condition that weakens my immune system or have been on strong immune-suppressing drugs recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 29, day 366

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 29, day 366

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 29, day 366 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ebola-specific Antibody Titers

Secondary study objectives

Frequency of Adverse Events (AEs)

Frequency of Adverse Events Related to Bone Marrow Aspiration

Frequency of Adverse Events Related to Fine Needle Aspiration/Biopsy of Lymph Node

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Recombinant Vesicular Stomatitis Vaccine for Ebola (rVSV∆G-ZEBOV-GP)Experimental Treatment1 Intervention

Healthy adults who are at no risk for exposure to Ebola Virus and are not prior recipients of an Ebola vaccine receive a single dose of recombinant Vesicular Stomatitis Vaccine for Ebola (rVSV∆G-ZEBOV-GP).

0 / 5Eligibility criteria met