Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| VAC69120FLV1001 | Other Identifier | Janssen Vaccines & Prevention B.V. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.Filo as heterologous prime-boost vaccine regimens in healthy adult participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: AD26.Filo/MVA-BN-Filo or Placebo | Experimental | Participants will receive Ad26.Filo or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 57. |
|
| Group 2: MVA-BN-Filo/AD26.Filo or Placebo | Experimental | Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.Filo or placebo on Day 57. |
|
| Group 3: MVA-BN-Filo/AD26.Filo or Placebo | Experimental | Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.Filo or placebo on Day 15. |
|
| Subset of Group 3: AD26.Filo or Placebo | Experimental | The first 8 participants in Group 3 who are willing to enroll in the subset for third vaccination, will receive a third vaccination at Day 92. Participants who previously received placebo will receive placebo a third time and participants who previously received MVA-BN-Filo/Ad26.Filo vaccination will receive Ad26.Filo as third vaccination. After enrollment of the 8 participants, the unblinded monitor and unblinded pharmacist will assess whether 7 participants who previously received MVA-BN-Filo/Ad26.Filo vaccination have been enrolled. If less than 7 participants of the active vaccine regimen have been enrolled, 2 additional participants will be enrolled. If at least 7 participants of the active vaccine regimen have been enrolled, no further will be enrolled. The aim is to enroll 7 or 8 participants who will receive Ad26.Filo as third vaccination. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ad26.Filo | Biological | Ad26.Filo intramuscular (IM) injection at a dose of 9*10^10 viral particles (vp). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse events (AEs) | Up to 28 days after the last vaccination | |
| Number of Participants With Reactogenicity (ie, Solicited Local and Systemic Adverse Events) | One Week after each study vaccine administration | |
| Number of Participants With Serious Adverse Events | Up to the end of long-term follow-up (Day 360) |
| Measure | Description | Time Frame |
|---|---|---|
| Binding Antibody Responses Against Ebola Virus (EBOV), Marburg Virus (MARV), and Sudan Virus (SUDV) Glycoproteins (GPs) | Up to Day 360 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Vaccines & Prevention B.V. Clinical Trial | Janssen Vaccines & Prevention B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rockville | Maryland | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36197845 | Derived | Bockstal V, Shukarev G, McLean C, Goldstein N, Bart S, Gaddah A, Anumenden D, Stoop JN, Marit de Groot A, Pau MG, Hendriks J, De Rosa SC, Cohen KW, McElrath MJ, Callendret B, Luhn K, Douoguih M, Robinson C. First-in-human study to evaluate safety, tolerability, and immunogenicity of heterologous regimens using the multivalent filovirus vaccines Ad26.Filo and MVA-BN-Filo administered in different sequences and schedules: A randomized, controlled study. PLoS One. 2022 Oct 5;17(10):e0274906. doi: 10.1371/journal.pone.0274906. eCollection 2022. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Group 4: Ad26.ZEBOV/MVA-BN-Filo or placebo | Experimental | Participants will receive Ad26.ZEBOV or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 57. |
|
| MVA-BN-Filo | Biological | MVA-BN-Filo intramuscular (IM) injection at a dose of 5*10^8 infectious units (Inf U). |
|
| Ad26.ZEBOV | Biological | Ad26.ZEBOV intramuscular (IM) injection at a dose of 5*10^10 vp. |
|
| Placebo | Biological | IM injection of 0.9 percent saline. |
|
| MVA-BN-Filo | Biological | MVA-BN-Filo intramuscular (IM) injection at a dose of 1*10^8 Inf U. |
|