Safety, Tolerability and Immunogenicity Study of 2-dose Heterologous Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo
Condition: Hemorrhagic Fever, Ebola
MeSH terms: Hemorrhagic Fever, Ebola; Hemorrhagic Fevers, Viral
Intervention: Ad26.ZEBOV; MVA-BN-Filo; Placebo
Intervention description: One 0.5 mL intramuscular (IM) injection of (5x10*10 viral particles).; One 0.5 mL IM injection of (1x10*8 infectious units).; One 0.5 mL IM injection of 0.9 percent (%) saline.
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: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 578.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy; Vaccine; Ebola viruses; Ebola virus disease (EVD); Filoviruses; Hemorrhagic fever; Monovalent vaccine; Human adenovirus serotype 26 (Ad26) encoding the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV); Modified Vaccinia Virus Ankara - Bavarian Nordic (MVA-BN) Filo-vector; Safety; Immunogenicity

Summary:

      The purpose of this study is to assess the safety, tolerability and immunogenicity of
      different vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly
      (IM) as 2-dose heterologous regimens in healthy and in HIV-infected adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must be healthy in the Investigator's clinical judgment on the basis of
             medical history, physical examination and vital signs performed at Screening

          -  Participant must be healthy on the basis of clinical laboratory tests and
             electrocardiogram (ECG) (only in participants >50 years) performed at Screening. If
             the results of the laboratory screening tests and ECG are outside the institutional
             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

          -  A woman of childbearing potential must have a negative urine β-human chorionic
             gonadotropin [beta-hCG] pregnancy test at Screening and a negative urine [beta-hCG]
             pregnancy test immediately prior to each study vaccine administration

          -  A man who is sexually active with a woman of childbearing potential must be willing to
             use condoms for sexual intercourse beginning prior to dose 1 vaccination until at
             least 3 months after the dose 2 vaccination, unless a vasectomy was performed more
             than 1 year prior to Screening

          -  Participant must pass the test of understanding (TOU)

          -  Additional Inclusion Criteria for HIV-infected participants a) participants must have
             a positive HIV-1 and/or -2 serology test within 6 months of screening, including the
             day of screening; b) participants must have a Screening CD4+ cell count >200
             cells/microliter (mcL); c) in part 1, all participants must be on a stable highly
             active antiretroviral therapy (HAART) regimen for 4 weeks prior to Screening, in part
             2 participants with screening CD4+ cell count <350 cells/mcL must also be on a stable
             HAART regimen for 4 weeks prior to Screening

        Exclusion Criteria:

          -  Has received any candidate Ebola vaccine

          -  Diagnosed with Ebola virus disease, or prior exposure to EBOV, including travel to
             epidemic Ebola areas less than 1 month prior to Screening

          -  Has received any experimental candidate Ad26- or MVA-based vaccine in the past or
             received any other investigational drug or investigational vaccine or used an invasive
             investigational medical device within 3 months prior to Screening

          -  Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines
             or vaccine products

          -  Presence of significant conditions (eg, history of seizure disorders, (auto)immune
             disease or deficiency, any spleen disease, active malignancy, ongoing tuberculosis
             treatment, other systemic infections) or clinically significant findings during
             screening of medical history, ECG (only in participants >50 years), physical
             examination, vital signs or laboratory testing for which, in the opinion of the
             investigator, participation would not be in the best interest of the participants (eg,
             compromise the safety or well-being) or that could prevent, limit, or confound the
             protocol-specified assessments