Partnership for Research on Ebola VACcinations
Condition: Ebola Virus Disease
MeSH terms: Virus Diseases; Hemorrhagic Fever, Ebola
Intervention: Ad26.ZEBOV; MVA-BN-Filo; rVSVΔG-ZEBOV-GP; Placebo; rVSV boost
Intervention description: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children; 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children; 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children; 0.5 mL or 1 mL (depending upon the arm) sterile normal saline administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children; 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4789.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Ebola Vaccine

Summary:

      The purpose of this study is to evaluate the safety and immunogenicity of three vaccine
      strategies that may prevent Ebola virus disease (EVD) events in children and adults.
      Participants will receive either the Ad26.ZEBOV (rHAd26) vaccine with a MVA-BN-Filo (MVA)
      boost, or the rVSVΔG-ZEBOV-GP (rVSV) vaccine with or without boosting, or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent/assent

          -  Age greater than or equal to 1 year

          -  Planned residency in the area of the study site for the next 12 months

          -  Willingness to comply with the protocol requirements

        Exclusion Criteria:

          -  Fever greater than 38º Celsius

          -  History of EVD (self-report)

          -  Pregnancy (a negative urine pregnancy test is required for females of child-bearing
             potential, i.e., females who have experienced menarche or who are aged 14 years and
             older)

          -  Positive HIV test for participants less than 18 years of age

          -  Reported current breast-feeding

          -  Prior vaccination against Ebola (self-report)

          -  Any vaccination in the past 28 days or planned within the 28 days after randomization
             (initial vaccination)

          -  In the judgement of the clinician, any clinically significant acute/chronic condition
             that would limit the ability of the participant to meet the requirements of the study
             protocol

        Inclusion Criteria for Revaccination Post 12 Month Visit:

          -  Participants who received the placebo

          -  Participants who received an incomplete Ad26.ZEBOV/MVA-BN-Filo vaccine strategy

        Temporary Exclusion Criteria for Revaccination Post 12 Month Visit:

          -  Fever greater than 38º Celsius

          -  Pregnancy (a negative urine pregnancy test is required for females of child-bearing
             potential, i.e., females who have experienced menarche or who are aged 14 years and
             older)

          -  Reported current breast-feeding (self-report)

          -  Any vaccination in the past 28 days or planned within the 28 days after trial
             vaccination

        Exclusion Criteria for Revaccination Post 12 Month Visit:

          -  EVD notified in the electronic case report form

          -  For minor participants: change in HIV status since enrollment (self-report)

          -  Previous Ebola vaccination outside of the study including incomplete vaccine
             strategies

          -  Known medical history or significant risk factors for a thrombotic and/or
             thrombocytopenic event (for participants who will receive the Ad26.ZEBOV or
             MVA-BN-Filo vaccine)