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NCT02416453

A Study to Assess Safety, Tolerability, and Immunogenicity of Three Heterologus 2-dose Regimens of the Candidate Prophylactic Vaccines for Ebola in Healthy Adults

Completed Phase 2 Results posted Last 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.

Timeline
15 June 2015
Primary endpoint
19 January 2018
19 January 2018

Quick facts

Lead sponsorJanssen Vaccines & Prevention B.V.
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment423
Start date15 June 2015
Primary completion19 January 2018
Estimated completion19 January 2018
Sites11 locations across France, United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Janssen Vaccines & Prevention B.V. — full company profile →

Who can join

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

GroupValue95% 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: Placebo6
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)52
Group 2: Pooled Cohorts II and III: Placebo7
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)46
Group 3: Pooled Cohorts II and III: Placebo8
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.

GroupValue95% 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: Placebo0
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)4
Group 2: Pooled Cohorts II and III: Placebo1
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)5
Group 3: Pooled Cohorts II and III: Placebo1
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

GroupValue95% 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: Placebo0
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)2
Group 2: Pooled Cohorts II and III: Placebo0
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)2
Group 3: Pooled Cohorts II and III: Placebo0
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.

GroupValue95% 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: Placebo3
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)65
Group 2: Pooled Cohorts II and III: Placebo2
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)78
Group 3: Pooled Cohorts II and III: Placebo4
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.

GroupValue95% 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: Placebo2
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)49
Group 2: Pooled Cohorts II and III: Placebo0
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)41
Group 3: Pooled Cohorts II and III: Placebo0
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.

GroupValue95% 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: Placebo7
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)84
Group 2: Pooled Cohorts II and III: Placebo8
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)82
Group 3: Pooled Cohorts II and III: Placebo7
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.

GroupValue95% 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: Placebo5
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)36
Group 2: Pooled Cohorts II and III: Placebo2
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)38
Group 3: Pooled Cohorts II and III: Placebo4
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

GroupValue95% CI
Group 4: Ad26.ZEBOV6
Group 4: Placebo1
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.

GroupValue95% CI
Group 4: Ad26.ZEBOV2
Group 4: Placebo0
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

GroupValue95% CI
Group 4: Ad26.ZEBOV0
Group 4: Placebo0
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.

GroupValue95% CI
Group 4: Ad26.ZEBOV8
Group 4: Placebo0
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.

GroupValue95% CI
Group 4: Ad26.ZEBOV11
Group 4: Placebo1

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)

ReactionSystemGroup 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.ZEBOVGroup 4: Placebo
HaemorrhoidsGastrointestinal disorders
Inguinal herniaGastrointestinal disorders
Cholecystitis acuteHepatobiliary disorders
Food allergyImmune system disorders
CellulitisInfections and infestations
Chronic sinusitisInfections and infestations
Hepatitis AInfections and infestations
Human papilloma virus test positiveInvestigations
Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)
OsteosarcomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebral venous thrombosisNervous system disorders
Miller Fisher syndromeNervous system disorders
Small fibre neuropathyNervous system disorders
Abortion spontaneousPregnancy, puerperium and perinatal conditions
AppendicectomySurgical and medical procedures
Other adverse events (43 terms — click to expand)

ReactionSystemGroup 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.ZEBOVGroup 4: Placebo
RhinitisInfections and infestations
Upper respiratory tract infectionInfections and infestations
HeadacheNervous system disorders
RhinorrhoeaRespiratory, thoracic and mediastinal disorders
NasopharyngitisInfections and infestations
Alanine aminotransferase increasedInvestigations
Aspartate aminotransferase increasedInvestigations
Neutrophil count decreasedInvestigations
Back painMusculoskeletal and connective tissue disorders
NauseaGastrointestinal disorders
Influenza like illnessGeneral disorders
PharyngitisInfections and infestations
Musculoskeletal painMusculoskeletal and connective tissue disorders
CoughRespiratory, thoracic and mediastinal disorders
VertigoEar and labyrinth disorders
Dental discomfortGastrointestinal disorders
DiarrhoeaGastrointestinal disorders
OdynophagiaGastrointestinal disorders
Oral painGastrointestinal disorders
ToothacheGastrointestinal disorders
VomitingGastrointestinal disorders
Application site bruiseGeneral disorders
AstheniaGeneral disorders
Injection site erythemaGeneral disorders
Injection site painGeneral disorders
PyrexiaGeneral disorders
CellulitisInfections and infestations
ConjunctivitisInfections and infestations
Tooth abscessInfections and infestations
Urinary tract infectionInfections and infestations
Ligament sprainInjury, poisoning and procedural complications
Blood creatinine increasedInvestigations
Prothrombin time prolongedInvestigations
ArthralgiaMusculoskeletal and connective tissue disorders
ChondropathyMusculoskeletal and connective tissue disorders
OsteoarthritisMusculoskeletal and connective tissue disorders
Pain in extremityMusculoskeletal and connective tissue disorders
Dizziness posturalNervous system disorders
DysgeusiaNervous system disorders
AsthmaRespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: Haemorrhoids, Inguinal hernia, Cholecystitis acute, Food allergy, Cellulitis, Chronic sinusitis, Hepatitis A, Human papilloma virus test positive.

Data from ClinicalTrials.gov NCT02416453 adverse events section.

Sponsor's own description

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):

  1. Safety and immunogenicity of a two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Europe (EBOVAC2): a randomised, observer-blind, participant-blind, placebo-controlled, phase 2 trial.
    Pollard AJ, Launay O, Lelievre JD, Lacabaratz C, et al · · 2021 · cited 129× · PMID 33217361 · DOI 10.1016/s1473-3099(20)30476-x
  2. Vaccines based on replication incompetent Ad26 viral vectors: Standardized template with key considerations for a risk/benefit assessment.
    Custers J, Kim D, Leyssen M, Gurwith M, et al · · 2021 · cited 59× · PMID 33676782 · DOI 10.1016/j.vaccine.2020.09.018
  3. Targeting natural killer cells to enhance vaccine responses.
    Cox A, Cevik H, Feldman HA, Canaday LM, et al · · 2021 · cited 47× · PMID 34311992 · DOI 10.1016/j.tips.2021.06.004
  4. Ebola: Lessons on Vaccine Development.
    Feldmann H, Feldmann F, Marzi A. · · 2018 · cited 40× · PMID 30200851 · DOI 10.1146/annurev-micro-090817-062414
  5. Ebola vaccines in clinical trial: The promising candidates.
    Wang Y, Li J, Hu Y, Liang Q, et al · · 2017 · cited 40× · PMID 27764560 · DOI 10.1080/21645515.2016.1225637
  6. Vaccines against Ebola virus and Marburg virus: recent advances and promising candidates.
    Suschak JJ, Schmaljohn CS. · · 2019 · cited 37× · PMID 31589088 · DOI 10.1080/21645515.2019.1651140
  7. Safety and Immunogenicity of Heterologous and Homologous 2-Dose Regimens of Adenovirus Serotype 26- and Modified Vaccinia Ankara-Vectored Ebola Vaccines: A Randomized, Controlled Phase 1 Study.
    Goldstein N, Bockstal V, Bart S, Luhn K, et al · · 2022 · cited 31× · PMID 32939546 · DOI 10.1093/infdis/jiaa586
  8. Ebola Virus Infection: Overview and Update on Prevention and Treatment.
    Martínez MJ, Salim AM, Hurtado JC, Kilgore PE. · · 2015 · cited 23× · PMID 26363787 · DOI 10.1007/s40121-015-0079-5

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Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing