Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MVA-BN-Filo · 1 trial · 1 indication
An adverse event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal product, it does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal product. Unsolicited adverse events were events which were reported by the participant voluntarily or obtained by means of interviewing the participant in a nondirected manner at study visits.
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
The following neuroinflammatory disorders were considered immediate reportable events and which had to be reported to the sponsor within 24 hours of becoming aware of the event. Neuroinflammatory disorders included: cranial nerve disorders including paralyses/paresis (example: bell's palsy), optic neuritis, multiple sclerosis, transverse myelitis, guillain-barre syndrome including miller fisher syndrome, bickerstaff's encephalitis and other variants, acute disseminated encephalomyelitis, including site-specific variants (example: non-infectious encephalitis, encephalomyelitis, myelitis, myeloradiculomyelitis), myasthenia gravis and lambert-eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, including chronic inflammatory, demyelinating polyneuropathy, multifocal motor neuropathy, and polyneuropathies associated with monoclonal gammopathy, narcolepsy, isolated paresthesia of more than 7 days duration.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post first vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Participants will receive intramuscular (IM) injection of Ad26.ZEBOV/Placebo on Day 1 followed by IM injection of MVA-BN-Filo/Placebo on Day 29. |
| Group 2 | EXPERIMENTAL | Participants will receive IM injection of Ad26.ZEBOV/Placebo on Day 1 followed by IM injection of MVA-BN-Filo/Placebo on Day 57. |
| Group 3 | EXPERIMENTAL | Participants will receive IM injection of Ad26.ZEBOV/Placebo on Day 1 followed by IM injection of MVA-BN-Filo/Placebo on Day 85. |
| Name | Type | Description |
|---|---|---|
| MVA-BN-Filo | BIOLOGICAL | One 0.5 mL intramuscular (IM) injection of 1E8 Infectious Unit \[Inf. U.\] on Day 29, 57, or 85. |
| Ad26.ZEBOV | BIOLOGICAL | One 0.5 mL IM injection of 5E10 viral particles (vp) on Day 1. |
| Placebo | BIOLOGICAL | One 0.5 mL IM injection of 0.9% saline on Day 1 and Day 29, 57, or 85. |
Inclusion Criteria: * Must be healthy in the Investigator's clinical judgment on the basis of medical history, physical examination, electrocardiogram (ECG) and vital signs performed at Screening * Must be healthy on the basis of clinical laboratory tests performed at Screening. If the results of t...
MVA-BN-Filo is an investigational prophylactic vaccine candidate developed for the prevention of Ebola viral disease. It was studied in healthy adult volunteers as part of a heterologous two-dose vaccination regimen. It is not an approved product and remains in clinical development.
MVA-BN-Filo is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the clinical evaluation of the candidate Ebola vaccine regimen in healthy adult volunteers.
MVA-BN-Filo has been evaluated in a Phase 2 clinical trial. That study has completed, and no trials of this candidate are currently listed as active. It is an investigational vaccine candidate and has not been approved for commercial use.
MVA-BN-Filo was studied in NCT02416453, a Phase 2 trial titled A Study to Assess Safety, Tolerability, and Immunogenicity of Three Heterologous 2-dose Regimens of the Candidate Prophylactic Vaccines for Ebola in Healthy Adults. The completed trial enrolled 423 participants across France and the United Kingdom.
The Phase 2 study NCT02416453 was a randomized, double-blind, controlled trial evaluating three heterologous two-dose regimens of candidate prophylactic Ebola vaccines. It enrolled 423 healthy adults aged 18 years and older of all sexes in France and the United Kingdom, and the trial has completed.