The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV as heterologous and homologous prime-boost vaccine regimens in healthy adult participants.
This study consists of 3 parts: the first and third part with standard doses and the second part with higher doses. All parts are randomized, placebo-controlled, observer-blind to evaluate the safety, tolerability and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV administered in different doses, sequences and schedules to healthy adult participants. The study consists of a screening period of up to 28 days, a vaccination period in which participants will be vaccinated at baseline (Day 1) followed by a boost on Day 15, 29, or 57, and third vaccine 1-year post-prime (3rd vaccination is optional for subjects in groups 1-8). The total duration of the study will be about 1 year for participants who wiil receive boost vaccine and about 3 months for participants who will receive placebo and 2 year for participants who will receive a 3rd dose. Safety will be monitored during the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
164
One 0.5 milliliter (ml) intramuscular (IM) injection of 1\*10\^8, (50%Tissue Culture Infectious Dose \[TCID50\]).
One 0.5 mL IM injection of 5\*10\^10 viral particles (vp).
One 0.5 milliliter (ml) intramuscular (IM) injection of 4.4\*10\^8, (50%Tissue Culture Infectious Dose \[TCID50\]).
Unnamed facility
Rockville, Maryland, United States
Number of participants with adverse events
Time frame: Up to 21 days after the last vaccination (up to Day 381)
Number of participants with serious adverse events
Time frame: Up to the end of long term follow-up (up to Day 720)
Number of participants with reactogenicity (ie, solicited local and systemic adverse events)
Time frame: 1 week after each study vaccine administration
Immune responses to the study vaccine regimens as measured by a virus neutralization assay
Time frame: up to Day 720 (Group 1-8); Day 360 (Group 9, 10)
Immune responses to the study vaccine regimens as measured by an enzyme-linked immunosorbent assay (ELISA)
Time frame: up to Day 720 (Group 1-8); Day 360 (Group 9, 10)
Immune responses to the study vaccine regimens as measured by an enzyme-linked immunospot (ELISpot) assay
Time frame: up to Day 720 (Group 1-8); Day 360 (Group 9, 10)
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One 0.5 mL IM injection of 1\*10\^11 viral particles (vp).
One 0.5 mL IM injection of 0.9% saline.