The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV administered as heterologous prime-boost vaccine regimens in healthy adult participants.
This is a randomized placebo-controlled, double-blind 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 of up to 28 days, a vaccination period in which participants will be vaccinated at Baseline \[Day 1\] followed by a boost on Day 29 or 57 and a post-boost follow-up, until all participants have had their 21-day post-boost visit (Day 50 or Day 78). The participants who received active vaccine will enter a long-term follow-up. 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. Immunogenicity and safety will be monitored during the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
78
One 0.5 milliliter (ml) intramuscular (IM) injection of 1\*10\^8, (50%Tissue Culture Infectious Dose \[TCID50\]) on Day 1, 29 or 57.
One 0.5 mL IM injection of 5\*10\^10 viral particles (vp) on Day 1, 29 or 57.
One 0.5 mL IM injection of 0.9% saline on Day 1 and 29 or on Day 1 and 57.
Unnamed facility
Mwanza, Tanzania
Unnamed facility
Entebbe, Uganda
Number of Participants With Adverse Events
Time frame: Up to 21 days post-boost (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 (that is, 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: Groups 1 and 3: Days 1 (pre-vaccination), 8, 29 (pre-vaccination), 36, 50, 113, 180, 240, and 360; Groups 2 and 4: Days 1 (pre-vaccination), 8, 29, 57 (pre-vaccination), 64, 78, 141, 180, 240, and 360)
Immune Responses to the Study Vaccine Regimens Measured by an Enzyme-linked Immunosorbent Assay (ELISA)
Time frame: Groups 1 and 3: Days 1 (pre-vaccination), 8, 29 (pre-vaccination), 36, 50, 113, 180, 240, and 360; Groups 2 and 4: Days 1 (pre-vaccination), 8, 29, 57 (pre-vaccination), 64, 78, 141, 180, 240, and 360)
Immune Responses to the Study Vaccine Regimens as Measured by an Enzyme-linked Immunospot (ELIspot) Assay
Time frame: Groups 1 and 3: Days 1 (pre-vaccination), 8, 29 (pre-vaccination), 36, 50, 113, 180, 240, and 360; Groups 2 and 4: Days 1 (pre-vaccination), 8, 29, 57 (pre-vaccination), 64, 78, 141, 180, 240, and 360)
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