A Safety Trial to Test MVA-BN(R)-Filo and Ad26.ZEBOV Vaccines in Healthy Volunteers
Condition: Ebola Disease; Marburg Disease
MeSH terms: Marburg Virus Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, double-blind, randomized trial to evaluate the safety and immunogenicity
      of two heterologous and two homologous prime-boost regimens using MVA-BN(R)-Filo and
      Ad26.ZEBOV administered in different sequences at Days 1 and 29 in healthy adult subjects
      aged 18 - 45 years. The study will evaluate the 'omics (transcriptomics, proteomics,
      lipidomics, metabolomics), antibodies for immunogenicity, CMI, ADCC, and plasmablast
      responses to MVA-BN(R)-Filo and Ad26.ZEBOV vaccines. The primary objectives of this study
      are: 1) To assess the safety and reactogenicity of each study group. 2) To assess responses
      to the study vaccination by study group after the first, second and third dose by
      transcriptomics. 3) To assess the peak antibody response to the study vaccination by study
      group to filovirus antigens.
    

Detailed description: 
      This is a Phase 1, double-blind, randomized trial to evaluate the safety and immunogenicity
      of two heterologous and two homologous prime-boost regimens using MVA-BN(R)-Filo and
      Ad26.ZEBOV administered in different sequences at Days 1 and 29 in healthy adult subjects
      aged 18 - 45 years. The two heterologous prime-boost groups will also receive MVA-BN(R)-Filo
      at day 366. Sixty subjects will be randomized 1:1:1:1 to one of four study groups (15 per
      group). Subjects and study staff will be blinded to a subject's study vaccine assignment
      within study vaccination schedule (e.g., enrollment into Group 1 or 4 versus 2 or 3 will be
      known). The study will evaluate the 'omics (transcriptomics, proteomics, lipidomics,
      metabolomics), antibodies for immunogenicity, CMI, ADCC, and plasmablast responses to
      MVA-BN(R)-Filo and Ad26.ZEBOV vaccines. The primary objectives of this study are: 1) To
      assess the safety and reactogenicity of each study group. 2) To assess responses to the study
      vaccination by study group after the first, second and third dose by transcriptomics. 3) To
      assess the peak antibody response to the study vaccination by study group to filovirus
      antigens. Secondary objectives are: 1) To assess antigen-specific cell-mediated immune (CMI)
      responses to the study vaccination by study group. 2) To assess antibody-dependent
      cell-mediated cytotoxicity (ADCC) responses to the study vaccination by study group.
    

Intervention name(s): Ad26 Zaire Ebola Vaccine; MVA Multi-Filo Ebola Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): A recombinant adenovirus vector comprising a polynucleotide encoding a filovirus antigenic protein, wherein the recombinant adenovirus vector comprises an adenovirus 26 capsid protein.; A multivalent MVA-BN Filovirus vaccine, designed to protect against Ebola Zaire, Ebola Sudan and Marburg virus.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Ad26.ZEBOV; Ebola; Immunogenicity; Marburg; MVA-BN-Filo; Omics; Zaire