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| ID | Type | Description | Link |
|---|---|---|---|
| VAC52150EBL3003 | Other Identifier | Crucell Holland BV |
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The purpose of this study is to compare the humoral immune response induced by 3 different batches of Ad26.ZEBOV as measured by enzyme - linked immunosorbent assay (ELISA) against the Ebola virus (EBOV) GP (Glycoprotein) at 56 days post prime.
This is a randomized, double - blind, placebo - controlled, parallel - group, multicenter, Phase 3 study to evaluate the immunogenic equivalence of a heterologous prime - boost regimen using 3 different batches of Ad26.ZEBOV in healthy adult participants. The study consists of a screening period of up to 6 weeks, a vaccination period in which participants will be vaccinated at baseline (Day 1), followed by a boost vaccination on Day 57, and a post-vaccination phase until 6 months post-boost visit (Day 237). The participants will be randomized at baseline (on Day 1) in a 2:2:2:1 ratio to Groups 1, 2, 3 and 4. Safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Ad26.ZEBOV -Batch #1, single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo, single dose IM injection on Day 57 |
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| Group 2 | Experimental | Ad26.ZEBOV -Batch #2, single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo, single dose IM injection on Day 57 |
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| Group 3 | Experimental | Ad26.ZEBOV -Batch #3, single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo, single dose IM injection on Day 57 |
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| Group 4 | Experimental | Placebo (0.9% saline)- single dose IM injection on Day 1 and Day 57 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ad26.ZEBOV-Batch #1 | Biological | Ad26.ZEBOV - Batch #1, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5*10^10 viral particles on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein enzyme-linked immunosorbent assay (ELISA) | The humoral immune response will be assessed by enzyme-linked immunosorbent assay (ELISA) binding antibody | At 56 days post prime vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein enzyme-linked immunosorbent assay (ELISA) | The humoral immune response will be assessed by enzyme-linked immunosorbent assay (ELISA) binding antibody | At Days 1, 29 post prime dose and at days 21, 42, and 180 post boost vaccination |
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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 |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34930928 | Derived | Bockstal V, Gaddah A, Goldstein N, Shukarev G, Bart S, Luhn K, Robinson C, Anumendem D, Leyssen M, Douoguih M. Assessments of different batches and dose levels of a two-dose Ad26.ZEBOV and MVA-BN-Filo vaccine regimen. NPJ Vaccines. 2021 Dec 20;6(1):157. doi: 10.1038/s41541-021-00402-8. |
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| Ad26.ZEBOV-Batch #2 | Biological | Ad26.ZEBOV - Batch #2, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5*10^10 viral particles on Day 1 |
|
| Ad26.ZEBOV-Batch #3 | Biological | Ad26.ZEBOV - Batch #3, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5*10^10 viral particles on Day 1 |
|
| MVA-BN-Filo | Biological | MVA-BN-Filo- live replication incompetent vaccine, 0.5 mL IM injection of 1*10^8 Infectious Unit [Inf. U.] once on Day 57. |
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| Placebo | Biological | One 0.5 ml IM injection of 0.9% saline once on Day 1 and Day 57. |
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| Number of Participants with Solicited Local and Systemic Adverse Events (AEs) | Up to 7 days after each vaccination |
| Number of Participants with Adverse Events (AEs) | Up to 42 days post boost vaccination |
| Number of Participants with Serious Adverse Events (SAEs) | Continuous throughout the duration of study (Up to 180 Days post boost vaccination) |
| San Diego |
| California |
| United States |
| Melbourne | Florida | United States |
| Peoria | Illinois | United States |
| Mishawaka | Indiana | United States |
| Rockville | Maryland | United States |
| ID | Term |
|---|---|
| D019142 | Hemorrhagic Fever, Ebola |
| ID | Term |
|---|---|
| D006482 | Hemorrhagic Fevers, Viral |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D018702 | Filoviridae Infections |
| D018701 | Mononegavirales Infections |
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