The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV as heterologous prime-boost vaccine regimens in healthy adult participants.
This first-in-human study consists of 2 parts: 1) The main study, which is randomized, placebo-controlled, observer-blind; 2) A sub-study, which is open-label, uncontrolled, non-randomized study evaluating the safety, tolerability, and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV administered in different sequences and schedules to healthy adult participants. The study consists of a Screening period (up to 28 days in the main study and up to 56 days in the sub-study), a vaccination period in which participants will be vaccinated at baseline (Day 1) followed by a boost on Day 15, 29 or 57, and a post-boost follow-up until all participants have had their 21-day post-boost visit (Day 36, 50 or Day 78). The total duration of the study will be about 1 year for participants who received vaccine and about 3 months for participants who received placebo. Safety will be monitored during the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
87
One 0.5 mL intramuscular (IM) injection of 1E8 (50%Tissue Culture Infectious Dose \[TCID50\]) on Day 1 (Groups 1 and 2), or on Day 29 (Group 3), or on Day 57 (Group 4), or on Day 15 (Group 5).
One 0.5 mL IM injection of 5E10 viral particles (vp) on Day 1 (Groups 3, 4 and 5), or on Day 29 (Group 1), or on Day 57 (Group 2).
One 0.5 mL IM injection of 0.9% saline on Day 1 and 29 (Groups 1 and 3), or on Day 1 and 57 (Groups 2 and 4).
Unnamed facility
Oxford, United Kingdom
Number of participants with adverse events
Time frame: Up to 21 days after the 2nd vaccination (Day 36 for Group 5 or Day 50 for Groups 1 and 3 or Day 78 for Groups 2 and 4)
Number of participants with serious adverse events
Time frame: Up to the end of long-term follow-up (Day 360)
Number of participants with reactogenicity (ie, solicited local and systemic adverse events)
Time frame: Up to 1 week after each study vaccine administration
Immune responses to the study vaccine regimens as measured by a virus neutralization assay
Time frame: Groups 1 and 3:Day 1(pre-vaccination), 8, 29(pre-vaccination), 36, 50, 180, 240, 360; Groups 2 and 4:Day 1(pre-vaccination), 8, 29, 57(pre-vaccination), 64, 78, 180, 240, 360; Group 5:Day 1(pre-vaccination), 8, 15(pre-vaccination), 22, 36, 180, 240, 360
Immune responses to the study vaccine regimens measured by an enzyme-linked immunosorbent assay (ELISA)
Time frame: Groups 1 and 3:Day 1(pre-vaccination), 8, 29(pre-vaccination), 36, 50, 180, 240, 360; Groups 2 and 4:Day 1(pre-vaccination), 8, 29, 57(pre-vaccination), 64, 78, 180, 240, 360; Group 5:Day 1(pre-vaccination), 8, 15(pre-vaccination), 22, 36, 180, 240, 360
Immune responses to the study vaccine regimens as measured by an enzyme-linked immunospot (ELISpot) assay
Time frame: Groups 1 and 3:Day 1(pre-vaccination), 8, 29(pre-vaccination), 36, 50, 180, 240, 360; Groups 2 and 4:Day 1(pre-vaccination), 8, 29, 57(pre-vaccination), 64, 78, 180, 240, 360; Group 5:Day 1(pre-vaccination), 8, 15(pre-vaccination), 22, 36, 180, 240, 360
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