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.
Age range
18 Years – 45 Years
Sex
ALL
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Determine the differential expression from baseline in mRNA after each study vaccination by study group
Timeframe: Screening and Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 for Groups 1 and 4; additionally Days 366, 367, 369, 373, 380, 394, and 546 for Groups 2 and 3.
Determine the number of subjects with a vaccine-related serious adverse event (SAE) from the time of first study vaccination by study group through the duration of the study
Timeframe: Day 1 through Day 366 in Groups 1 and 4; Day 1 through Day 546 in Groups 2 and 3
Determine the number of subjects with a vaccine-related unsolicited adverse event (AE) from the time of each study vaccination by study group
Timeframe: Day 1 through Day 29
Determine the number of subjects with solicited local and systemic reactogenicity events from the time of study vaccination by study group.
Timeframe: Day 1 through Day 8
Determine the peak antibody response against filovirus glycoproteins (GPs) for each study group
Timeframe: Days 1, 15, 29, 36, 43, 57, 209, and 366 for Groups 1 and 4; additionally Days 369, 373, 380, 394, 546 for Groups 2 and 3.