A Study to Assess Safety, Tolerability, and Immunogenicity of Three Heterologus 2-dose Regimens of the Candidate Prophylactic Vaccines for Ebola in Healthy Adults
CompletedPhase 2Results postedLast updated 8 February 2021
What this trial tests
Phase 2 trial testing MVA-BN-Filo in Ebola Viral Disease in 423 participants. Completed in 19 January 2018.
Adults 18 to 65, any sex, with Ebola Viral Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Unsolicited Adverse Events (Groups 1, 2 and 3)Primary· Up to 42-day post dose 2 visit (Day 1 to Day 127)
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
Group
Value
95% CI
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
4
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
6
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
6
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
62
Group 1: Pooled Cohorts II and III: Placebo
6
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
52
Group 2: Pooled Cohorts II and III: Placebo
7
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
46
Group 3: Pooled Cohorts II and III: Placebo
8
Number of Participants With Serious Adverse Events (Groups 1, 2 and 3)Primary· Up to Day 365
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.
Group
Value
95% CI
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
0
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
1
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
0
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
2
Group 1: Pooled Cohorts II and III: Placebo
0
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
4
Group 2: Pooled Cohorts II and III: Placebo
1
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
5
Group 3: Pooled Cohorts II and III: Placebo
1
Number of Participants With Immediate Reportable Events (Groups 1, 2 and 3)Primary· Up to Day 365
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, myelor
Group
Value
95% CI
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
0
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
0
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
0
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
0
Group 1: Pooled Cohorts II and III: Placebo
0
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
2
Group 2: Pooled Cohorts II and III: Placebo
0
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
2
Group 3: Pooled Cohorts II and III: Placebo
0
Number of Participants With Solicited Local Adverse Events (Groups 1, 2 and 3)Primary· 7 days post-dose 1 (Day 8)
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.
Group
Value
95% CI
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
8
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
6
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
8
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
63
Group 1: Pooled Cohorts II and III: Placebo
3
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
65
Group 2: Pooled Cohorts II and III: Placebo
2
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
78
Group 3: Pooled Cohorts II and III: Placebo
4
Number of Participants With Solicited Local Adverse Events (Groups 1, 2 and 3)Primary· 7 days post-dose 2 (Up to Day 92)
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.
Group
Value
95% CI
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
4
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
5
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
8
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
46
Group 1: Pooled Cohorts II and III: Placebo
2
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
49
Group 2: Pooled Cohorts II and III: Placebo
0
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
41
Group 3: Pooled Cohorts II and III: Placebo
0
Number of Participants With Solicited Systemic Adverse Events (Groups 1, 2 and 3)Primary· 7 days post-dose 1 (Day 8)
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.
Group
Value
95% CI
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
8
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
10
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
10
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
89
Group 1: Pooled Cohorts II and III: Placebo
7
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
84
Group 2: Pooled Cohorts II and III: Placebo
8
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
82
Group 3: Pooled Cohorts II and III: Placebo
7
Number of Participants With Solicited Systemic Adverse Events (Groups 1, 2 and 3)Primary· 7 days post-dose 2 (Up to Day 92)
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.
Group
Value
95% CI
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
6
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
5
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
5
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
42
Group 1: Pooled Cohorts II and III: Placebo
5
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
36
Group 2: Pooled Cohorts II and III: Placebo
2
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
38
Group 3: Pooled Cohorts II and III: Placebo
4
Number of Participants With Unsolicited Adverse Events (Group 4)Secondary· Up to 28-day post dose 1 (Day 29)
An 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 mann
Group
Value
95% CI
Group 4: Ad26.ZEBOV
6
Group 4: Placebo
1
Number of Participants With Serious Adverse Events (Group 4)Secondary· Up to Day 180
A SAE was 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.
Group
Value
95% CI
Group 4: Ad26.ZEBOV
2
Group 4: Placebo
0
Number of Participants With Immediate Reportable Events (Group 4)Secondary· Up to Day 180
The following neuroinflammatory disorders were considered immediate reportable events 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, myeloradic
Group
Value
95% CI
Group 4: Ad26.ZEBOV
0
Group 4: Placebo
0
Number of Participants With Solicited Local Adverse Events (Group 4)Secondary· 7 days after each vaccination (Up to Day 8)
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.
Group
Value
95% CI
Group 4: Ad26.ZEBOV
8
Group 4: Placebo
0
Number of Participants With Solicited Systemic Adverse Events (Group 4)Secondary· 7 days after each vaccination (Up to Day 8)
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.
Group
Value
95% CI
Group 4: Ad26.ZEBOV
11
Group 4: Placebo
1
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to Day 365.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Serious: 0/10 (0%)
Deaths: 0/10
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Serious: 1/10 (10%)
Deaths: 0/10
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
Serious: 0/10 (0%)
Deaths: 0/10
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Serious: 2/112 (2%)
Deaths: 0/112
Group 1: Pooled Cohorts II and III: Placebo
Serious: 0/13 (0%)
Deaths: 0/13
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Serious: 4/114 (4%)
Deaths: 0/114
Group 2: Pooled Cohorts II and III: Placebo
Serious: 1/13 (8%)
Deaths: 0/13
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
Serious: 5/106 (5%)
Deaths: 0/106
Group 3: Pooled Cohorts II and III: Placebo
Serious: 1/18 (6%)
Deaths: 0/18
Group 4: Ad26.ZEBOV
Serious: 2/13 (15%)
Deaths: 0/13
Group 4: Placebo
Serious: 0/2 (0%)
Deaths: 0/2
Serious adverse events (15 terms)
Reaction
System
Group 1: Cohort I: Ad26.ZE…
Group 2: Cohort I: Ad26.ZE…
Group 3: Cohort I: Ad26.ZE…
Group 1: Pooled Cohorts II…
Group 1: Pooled Cohorts II…
Group 2: Pooled Cohorts II…
Group 2: Pooled Cohorts II…
Group 3: Pooled Cohorts II…
Group 3: Pooled Cohorts II…
Group 4: Ad26.ZEBOV
Group 4: Placebo
Haemorrhoids
Gastrointestinal disorders
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Inguinal hernia
Gastrointestinal disorders
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Cholecystitis acute
Hepatobiliary disorders
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Food allergy
Immune system disorders
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Cellulitis
Infections and infestations
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Chronic sinusitis
Infections and infestations
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Hepatitis A
Infections and infestations
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Human papilloma virus test positive
Investigations
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Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Osteosarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of 3 vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04556526 — A Study of a 2-dose Ebola Vaccine Regimen of Ad26.ZEBOV Followed by MVA-BN-Filo in Healthy Pregnant Women
· Phase 3
· completed
NCT04228783 — A Study of 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN-Filo in Adult Participants
· Phase 3
· completed
NCT03929757 — A Study of 2-dose Vaccination Regimen of Ad26.ZEBOV and MVA-BN-Filo in Infants
· Phase 2
· completed
NCT02876328 — Partnership for Research on Ebola VACcinations
· Phase 2
· completed
NCT02661464 — Long-term Safety Follow-up of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo
· Phase 3
· terminated
Other Janssen Vaccines & Prevention B.V. trials
Trials by the same sponsor.
NCT05901636 — A Clinical Study to Evaluate an Experimental Universal Influenza Vaccine, INFLUENZA G1 mHA, in Healthy Adults
· Phase 1, PHASE2
· completed
NCT05327816 — A Study of Various Respiratory Syncytial Virus (RSV) Pre-Fusion (preF)-Based Vaccine Formulations in Adults Aged 60 Year
· Phase 1, PHASE2
· terminated
NCT05091307 — A Study of Ad26.COV2.S and Influenza Vaccines in Healthy Adults
· Phase 3
· completed
NCT05101486 — A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years
· Phase 3
· completed
NCT05083585 — A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Ag
· Phase 3
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Janssen Vaccines & Prevention B.V.
Last refreshed: 8 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02416453.