A Study of 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN-Filo in Adult Participants
Condition: Ebola
Intervention: Ad26.ZEBOV; MVA-BN-Filo; Placebo
Intervention description: Participants will receive IM injection (0.5 mL) of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot A, B, and C) on Day 1 (Groups 1, 2, 3 and 5) and an Ad26.ZEBOV booster dose on Day 177 (Group 5).; Participants will receive IM injection (0.5 mL) of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 1, 2, 3 and 5) on Day 57.; Participants will receive IM injection (0.5 mL) of placebo (0.9 % saline) as Dose 1 on Day 1, followed by placebo as Dose 2 on Day 57 (Groups 4 and 6) and a booster of matching placebo on Day 177 (Group 6).
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 974.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to demonstrate that the paired 2-dose vaccine regimens from 3
      consecutively manufactured lots of Adenovirus serotype 26 encoding the Ebola virus Mayinga
      glycoprotein (Ad26.ZEBOV) as Dose 1 and 3 consecutively manufactured lots of Modified
      Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo)
      including the ebola virus mayinga glycoprotein as Dose 2, administered at a 56-day interval,
      induce an equivalent humoral immune response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed an informed consent form (ICF)

          -  Medically stable in the investigator's clinical judgment on the basis of physical
             examination, medical history, and vital signs performed at screening

          -  Before randomization, a woman must be either: a. Not of childbearing potential; b. Of
             childbearing potential and practicing an acceptable effective method of birth control
             and agrees to remain on such a method of birth control from signing the informed
             consent form (ICF) until at least 3 months post Dose 1 vaccination or 28 days post
             Dose 2 vaccination or 3 months post booster vaccination (Groups 5-6 only), whichever
             comes later. Use of hormonal contraception should start at least 28 days before the
             first administration of study vaccine. Acceptable effective methods for this study
             include: 1) hormonal contraception; 2) intrauterine device (IUD); 3) intrauterine
             hormone-releasing system (IUS); 4) male or female condom with or without spermicide;
             5) cap, diaphragm, or sponge with a vaginal spermicide; 6) vasectomized partner (the
             vasectomized partner should be the sole partner for that participant); 7) sexual
             abstinence

          -  Women of childbearing potential must have a negative urine Beta-human chorionic
             gonadotropin (Beta-hCG) pregnancy test at screening and immediately prior to each
             study vaccine administration

          -  Available and willing to participate for the duration of the study and follow-up visit

          -  Willing to provide verifiable identification

        Exclusion Criteria:

          -  Having received any candidate Ebola vaccine

          -  Diagnosed with Ebola virus disease (EVD), or prior exposure to Ebola virus, including
             travel to an area with Ebola outbreak less than 1 month prior to screening (if
             applicable)

          -  Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines
             or vaccine products (including any of the constituents of the study vaccines),
             including known allergy to egg, egg products, and aminoglycosides

          -  Presence of acute illness (this does not include minor illnesses such as diarrhea or
             mild upper respiratory tract infection) or temperature greater than or equal to (>=)
             38.0ºCelcius on Day 1. Participants with such symptoms will be excluded from
             enrollment at that time but may be rescheduled for enrollment at a later date

          -  Human immunodeficiency virus (HIV) type 1 or type 2 infection, based on the medical
             history reported by the participant

          -  Pregnant, breast-feeding

          -  History of an underlying clinically significant acute or chronic medical condition