A Study to Assess Safety, Tolerability, and Immunogenicity of Three Heterologus 2-dose Regimens of the Candidate Prophylactic Vaccines for Ebola in Healthy Adults
Condition: Ebola Viral Disease
MeSH terms: Hemorrhagic Fever, Ebola; Virus Diseases
Intervention: MVA-BN-Filo; Ad26.ZEBOV; Placebo
Intervention description: One 0.5 mL intramuscular (IM) injection of 1E8 Infectious Unit [Inf. U.] on Day 29, 57, or 85.; One 0.5 mL IM injection of 5E10 viral particles (vp) on Day 1.; One 0.5 mL IM injection of 0.9% saline on Day 1 and Day 29, 57, or 85.
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 423.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy; Ebola viruses; Ebola Viral Disease (EVD); Filoviruses; Monovalent vaccine; Human adenovirus serotype 26 (Ad26) encoding the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV); Modified Vaccinia Virus Ankara - Bavarian Nordic Filo-vector (MVA-BN Filo); Safety; Immunogenicity; Inserm and University of Oxford

Summary:

      The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of 3
      vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as
      2-dose heterologous regimens.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be healthy in the Investigator's clinical judgment on the basis of medical
             history, physical examination, electrocardiogram (ECG) and vital signs performed at
             Screening

          -  Must be healthy on the basis of clinical laboratory tests performed at Screening. If
             the results of the laboratory screening tests are outside the normal reference ranges,
             the participant may be included only if the Investigator judges the abnormalities or
             deviations from normal to be not clinically significant or to be appropriate and
             reasonable for the population under study

          -  Before randomization, a woman must be either of childbearing potential and practicing
             (or intending to practice) a highly effective method of birth control consistent with
             local regulations regarding the use of birth control methods for participants
             participating in clinical studies, beginning at least 28 days prior to vaccination OR
             not of childbearing potential: postmenopausal (greater than [>] 45 years of age with
             amenorrhea for at least 2 years or lesser than or equal to [<=] 45 years of age with
             amenorrhea for at least 6 months, and a serum follicle stimulating hormone (FSH) level
             >40 international unit per milliliter [IU/L]); permanently sterilized (for example,
             bilateral tubal occlusion [which includes tubal ligation procedures as consistent with
             local regulations], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or
             otherwise be incapable of pregnancy

          -  Woman of childbearing potential must have a negative serum (beta-human chorionic
             gonadotropin [beta-hCG]) at Screening and a negative urine beta-hCG pregnancy test
             immediately prior to each study vaccine administration

          -  Man who is sexually active with a woman of childbearing potential and has not had a
             vasectomy performed more than 1 year prior to screening must be willing to use condoms
             for sexual intercourse beginning prior to enrollment

        Exclusion Criteria:

          -  Having received any candidate Ebola vaccine

          -  Diagnosed with Ebola virus disease, or prior exposure to Ebola virus, including travel
             to West Africa less than 1 month prior to screening. West Africa includes but is not
             limited to the countries of Guinea, Liberia, Mali, and Sierra Leone

          -  Having received any experimental candidate adenovirus serotype 26 (vector: Ad26) or
             Modified Vaccinia Ankara (MVA-) based vaccine in the past

          -  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 or temperature greater than or equal to 38.0 C on Day 1