Partnership for Research on Ebola Vaccines in Liberia (PREVAIL)
Condition: Ebola Virus
MeSH terms: Hemorrhagic Fever, Ebola
Intervention: VSVG-ZEBOV; ChAd3-EBO Z; Placebo
Intervention description: The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV); The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1500.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Zaire Ebola Virus Disease

Summary:

      Background:

      - Ebola virus disease (EVD) affects many people in Liberia and other countries in West
      Africa. It is caused by the Ebola virus and makes people sick with fever, headache, vomiting,
      diarrhea, rash, and bleeding. About half the people with EVD die. There is no approved
      treatment for it. Researchers are studying two Ebola vaccines. The vaccines do not cause
      Ebola.

      Objectives:

      - To study the safety and efficacy of two Ebola vaccines.

      Eligibility:

      - Adults 18 and older who live in Liberia and are at risk for Ebola infection but have never
      had Ebola.

      Design:

        -  Participants will give information including birthdate, gender, occupation, and location
           of home. They will give contact information for themselves and 2 alternate contacts.
           They will give a history of their contact with people with Ebola. Some participants may
           have a physical. They may have blood taken.

        -  Participants will be injected with either an Ebola vaccine or a placebo with a needle in
           the upper arm. The placebo is a salt solution.

        -  Participants will have blood taken.

        -  Participants will be watched for 30 minutes.

        -  Participants will return to the clinic 1 week and 1 month after they get the shot. They
           will have blood taken.

        -  After that, participants will be contacted monthly to discuss how they are feeling. They
           may be contacted by phone, may visit the clinic, or may have a home visit.

        -  The study ends 8-12 months after participants get the shot. If one of the vaccines works
           against Ebola and does not have many side effects, participants can get the vaccine if
           they did not get it in the study.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

        The inclusion criteria for the study are broad reflecting the target population that would
        eventually receive an efficacious vaccine.

          -  Informed consent

          -  Age greater than or equal to 18 years

          -  Likely to be in the surrounding area of the vaccination center for at least one year.

        EXCLUSION CRITERIA:

          -  Fever greater than or equal to 38.0 degrees Celsius

          -  History of EVD (self-report)

          -  Current pregnancy (a negative urine pregnancy test is required for women of
             child-bearing potential)

          -  Breast-feeding an infant

          -  Any condition which would limit the ability of the participant to meet the
             requirements of the study protocol