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| ID | Type | Description | Link |
|---|---|---|---|
| VAC52150EBL1003 | Other Identifier | Crucell Holland BV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Participants will receive MVA-BN-filo/ Ad26.ZEBOV (Day 1 /Day 29) or Placebo (Day 1/Day 29). |
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| Group 2 | Experimental | Participants will receive MVA-BN-filo/Ad26.ZEBOV (Day 1 /Day 57) or placebo ( Day 1/Day 57). |
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| Group 3 | Experimental | Participants will receive Ad26.ZEBOV/ MVA-BN-filo (Day 1/Day 29) or placebo (Day 1/Day 29). |
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| Group 4 | Experimental | Participants will receive Ad26.ZEBOV/ MVA-BN-filo (Day 1/Day 57) or placebo (Day 1/Day 57). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MVA-BN-Filo | Biological | One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]) on Day 1, 29, 57. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | 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 | Up to the end of long-term follow-up (day 360) | |
| Number of participants with reactogenicity (ie, solicited local and systemic adverse events) | 1 week after each study vaccine administration |
| Measure | Description | Time Frame |
|---|---|---|
| Immune responses to the study vaccine regimens as measured by a virus neutralization assay | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Crucell Holland BV Clinical Trial | Crucell Holland BV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nairobi | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30796816 | Derived | Mutua G, Anzala O, Luhn K, Robinson C, Bockstal V, Anumendem D, Douoguih M. Safety and Immunogenicity of a 2-Dose Heterologous Vaccine Regimen With Ad26.ZEBOV and MVA-BN-Filo Ebola Vaccines: 12-Month Data From a Phase 1 Randomized Clinical Trial in Nairobi, Kenya. J Infect Dis. 2019 Jun 5;220(1):57-67. doi: 10.1093/infdis/jiz071. |
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| Ad26.ZEBOV | Biological | One 0.5 mL IM injection of 5*10^10 viral particles (vp) on Day 1, 29, 57. |
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| Placebo | Biological | One 0.5 mL IM injection of 0.9% saline on Day 1 and 29 or on Day 1 and 57. |
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| 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 Assay (ELISpot) | 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) |