A Study to Assess Safety, Tolerability, and Immunogenicit... | NCT02416453 | Trialant
NCT02416453
Sponsor
Janssen Vaccines & Prevention B.V.
Status
Completed
Last Update Posted
Feb 8, 2021Actual
Enrollment
423Actual
Phase
Phase 2
Conditions
Ebola Viral Disease
Interventions
MVA-BN-Filo
Ad26.ZEBOV
Placebo
Countries
France
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02416453
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR107227
Secondary IDs
ID
Type
Description
Link
VAC52150EBL2001
Other Identifier
Janssen Vaccines & Prevention B.V.
2015-000596-27
EudraCT Number
Brief Title
A Study to Assess Safety, Tolerability, and Immunogenicity of Three Heterologus 2-dose Regimens of the Candidate Prophylactic Vaccines for Ebola in Healthy Adults
Official Title
A Randomized, Observer-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Prime-Boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo in Healthy Adults in Europe
Acronym
Not provided
Organization
Janssen Vaccines & Prevention B.V.INDUSTRY
Status Module
Record Verification Date
Jan 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 15, 2015Actual
Primary Completion Date
Jan 19, 2018Actual
Completion Date
Jan 19, 2018Actual
First Submitted Date
Apr 10, 2015
First Submission Date that Met QC Criteria
Apr 10, 2015
First Posted Date
Apr 15, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 15, 2021
Results First Submitted that Met QC Criteria
Jan 15, 2021
Results First Posted Date
Feb 8, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 17, 2019
Certification/Extension First Submitted that Passed QC Review
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
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.
Detailed Description
This is a randomized, observer-blind, placebo-controlled, parallel-group, multicenter, Phase 2 study evaluating the safety, tolerability and immunogenicity of 2-dose heterologous regimens using Ad26.ZEBOV and MVA-BN-Filo administered to healthy adults participants in Europe. The study involves a screening period of up to 12 weeks, a vaccination period in which participants will be vaccinated with Ad26.ZEBOV (dose 1) followed by vaccination with MVA-BN-Filo (dose 2) 28, 56 or 84 days later, and a post-vaccination phase until 6 months post dose 2 visit (Days 209, 237 or 265). After unblinding, only participants who received Ad26.ZEBOV and/or MVA-BN-Filo will continue the study until the Day 365 visit (or until the start of the roll-over study or for an additional 12 months [whichever comes first] for participants in France who agree to continue the long-term follow-up after Day 365) to assess long-term safety and immunogenicity. Participants will enroll into 3 cohorts: that is, Cohort 1 (Participants will receive Ad26.ZEBOV and MVA-BN-Filo in an open-label fashion), Cohort 2 (Participants will be randomized to receive the 2-dose heterologous vaccine regimen with either Ad26.ZEBOV followed by MVA-BN-Filo, or placebo in a 14:1 ratio) and Cohort 3 (Participants will be randomized to receive the 2-dose heterologous vaccine regimen with either Ad26.ZEBOV followed by MVA-BN-Filo, or placebo in a 10:3 ratio). In Cohorts 2 and 3, core immunogenicity assessments (humoral and cellular assays) will be performed. In Cohort 2, additional immunogenicity assessments will be done. In Cohort 1, plasma blast response kinetics will be evaluated. Safety will be monitored during the study.
Conditions Module
Conditions
Ebola Viral Disease
Keywords
Healthy
Ebola viruses
Ebola Viral Disease (EVD)
Filoviruses
Monovalent vaccine
Human adenovirus serotype 26 (Ad26) encoding the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV)
Modified Vaccinia Virus Ankara - Bavarian Nordic Filo-vector (MVA-BN Filo)
Safety
Immunogenicity
Inserm and University of Oxford
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
423Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
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.
Biological: MVA-BN-Filo
Biological: Ad26.ZEBOV
Biological: Placebo
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.
Biological: MVA-BN-Filo
Biological: Ad26.ZEBOV
Biological: Placebo
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.
Biological: MVA-BN-Filo
Biological: Ad26.ZEBOV
Biological: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MVA-BN-Filo
Biological
One 0.5 mL intramuscular (IM) injection of 1E8 Infectious Unit [Inf. U.] on Day 29, 57, or 85.
Group 1
Group 2
Group 3
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Unsolicited Adverse Events (Groups 1, 2 and 3)
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.
Up to 42-day post dose 2 visit (Day 1 to Day 127)
Number of Participants With Serious Adverse Events (Groups 1, 2 and 3)
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.
Up to Day 365
Number of Participants With Immediate Reportable Events (Groups 1, 2 and 3)
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.
Up to Day 365
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Unsolicited Adverse Events (Group 4)
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 manner at study visits.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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 the laboratory screening tests are outside the normal reference ranges, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study
Before randomization, a woman must be either of childbearing potential and practicing (or intending to practice) a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for participants participating in clinical studies, beginning at least 28 days prior to vaccination OR not of childbearing potential: postmenopausal (greater than [>] 45 years of age with amenorrhea for at least 2 years or lesser than or equal to [<=] 45 years of age with amenorrhea for at least 6 months, and a serum follicle stimulating hormone (FSH) level >40 international unit per milliliter [IU/L]); permanently sterilized (for example, bilateral tubal occlusion [which includes tubal ligation procedures as consistent with local regulations], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy
Woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) at Screening and a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration
Man who is sexually active with a woman of childbearing potential and has not had a vasectomy performed more than 1 year prior to screening must be willing to use condoms for sexual intercourse beginning prior to enrollment
Exclusion Criteria:
Having received any candidate Ebola vaccine
Diagnosed with Ebola virus disease, or prior exposure to Ebola virus, including travel to West Africa less than 1 month prior to screening. West Africa includes but is not limited to the countries of Guinea, Liberia, Mali, and Sierra Leone
Having received any experimental candidate adenovirus serotype 26 (vector: Ad26) or Modified Vaccinia Ankara (MVA-) based vaccine in the past
Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccines including known allergy to egg, egg products and aminoglycosides
Presence of acute illness or temperature greater than or equal to 38.0 C on Day 1
Lacabaratz C, Durand M, Wiedemann A, Foucat E, Surenaud M, Krief C, Guillaumat L, Robinson C, Luhn K, Bockstal V, Thiebaut R, Richert L, Levy Y. Innate and Cellular Immune Response to the Ebola Vaccine Ad26.ZEBOV, MVA-BN-Filo: An Ancillary Study of the EBL2001 Phase 2 Trial. J Infect Dis. 2025 Feb 4;231(1):230-240. doi: 10.1093/infdis/jiae360.
A total of 423 participants were randomized (408 participants in Groups 1 to 3 and 15 participants in Group 4). Among them, 421 participants received at least one dose of study vaccines. Two participants were randomized but not vaccinated.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5*10^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
SAP
No
Yes
No
Statistical Analysis Plan
May 30, 2018
Jan 15, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
Ad26.ZEBOV
Biological
One 0.5 mL IM injection of 5E10 viral particles (vp) on Day 1.
Group 1
Group 2
Group 3
Placebo
Biological
One 0.5 mL IM injection of 0.9% saline on Day 1 and Day 29, 57, or 85.
Group 1
Group 2
Group 3
Number of Participants With Solicited Local Adverse Events (Groups 1, 2 and 3)
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.
7 days post-dose 1 (Day 8)
Number of Participants With Solicited Local Adverse Events (Groups 1, 2 and 3)
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.
7 days post-dose 2 (Up to Day 92)
Number of Participants With Solicited Systemic Adverse Events (Groups 1, 2 and 3)
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.
7 days post-dose 1 (Day 8)
Number of Participants With Solicited Systemic Adverse Events (Groups 1, 2 and 3)
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.
7 days post-dose 2 (Up to Day 92)
Up to 28-day post dose 1 (Day 29)
Number of Participants With Serious Adverse Events (Group 4)
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.
Up to Day 180
Number of Participants With Immediate Reportable Events (Group 4)
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, 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.
Up to Day 180
Number of Participants With Solicited Local Adverse Events (Group 4)
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.
7 days after each vaccination (Up to Day 8)
Number of Participants With Solicited Systemic Adverse Events (Group 4)
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.
7 days after each vaccination (Up to Day 8)
Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Filovirus Animal Non-Clinical Group (FANG) Enzyme-linked Immunosorbent Assay (ELISA) (Groups 1, 2 and 3)
GMCs of antibodies binding to EBOV GP using FANG ELISA were reported and were measured in ELISA unit per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using FANG ELISA to determine humoral responses following vaccination. For ELISA binding antibody responses, values below the lower limit of quantification (LLOQ) (36.11 ELISA units/mL). The outcome measure was planned to be reported at 21-day post dose 2. Therefore, the results are reported for Group 1, 2 and 3 only.
At 21-days post dose 2 (Day 50 for Group 1; Day 78 for Group 2; and Day 106 for Group 3)
Barry H, Lhomme E, Surenaud M, Nouctara M, Robinson C, Bockstal V, Valea I, Somda S, Tinto H, Meda N, Greenwood B, Thiebaut R, Lacabaratz C. Helminth exposure and immune response to the two-dose heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen. PLoS Negl Trop Dis. 2024 Apr 11;18(4):e0011500. doi: 10.1371/journal.pntd.0011500. eCollection 2024 Apr.
Pollard AJ, Launay O, Lelievre JD, Lacabaratz C, Grande S, Goldstein N, Robinson C, Gaddah A, Bockstal V, Wiedemann A, Leyssen M, Luhn K, Richert L, Betard C, Gibani MM, Clutterbuck EA, Snape MD, Levy Y, Douoguih M, Thiebaut R; EBOVAC2 EBL2001 study group. 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. Lancet Infect Dis. 2021 Apr;21(4):493-506. doi: 10.1016/S1473-3099(20)30476-X. Epub 2020 Nov 17.
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
FG002
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
FG003
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29.
FG004
Group 1: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 29.
FG005
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
FG006
Group 2: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 57.
FG007
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
FG008
Group 3: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 85.
FG009
Group 4: Ad26.ZEBOV
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp on Day 1.
FG010
Group 4: Placebo
Participants received IM injection of placebo Day 1.
FG00010 subjects
FG00110 subjects
FG00210 subjects
FG003112 subjects
FG00413 subjects
FG005114 subjects
FG00613 subjects
FG007106 subjects
FG00818 subjects
FG00913 subjects
FG0102 subjects
COMPLETED
FG0007 subjects
FG0017 subjects
FG0029 subjects
FG00397 subjects
FG00412 subjects
FG00598 subjects
FG00611 subjects
FG00794 subjects
FG00813 subjects
FG00913 subjects
FG0102 subjects
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG0021 subjects
FG00315 subjects
FG0041 subjects
FG00516 subjects
FG0062 subjects
FG00712 subjects
FG0085 subjects
FG0090 subjects
FG0100 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Lost to Follow-up
FG0001 subjects
FG0013 subjects
FG0020 subjects
FG0038 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0035 subjects
FG004
PARTICIPANT UNABLE TO ATTEND ANY FURTHER
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
PARTICIPANT HAS MOVED TO SINGAPORE
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5*10^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
BG001
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
BG002
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
BG003
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29.
BG004
Group 1: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 29.
BG005
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
BG006
Group 2: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 57.
BG007
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
BG008
Group 3: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 85.
BG009
Group 4: Ad26.ZEBOV
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp on Day 1.
BG010
Group 4: Placebo
Participants received IM injection of placebo Day 1.
BG011
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00010
BG00110
BG00210
BG003112
BG00413
BG005114
BG00613
BG007106
BG00818
BG00913
BG0102
BG011421
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00034.2± 12.95
BG00147.4± 16.53
BG00238.7± 13.99
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0016
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
France
Title
Measurements
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Unsolicited Adverse Events (Groups 1, 2 and 3)
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.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
Up to 42-day post dose 2 visit (Day 1 to Day 127)
ID
Title
Description
OG000
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5*10^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
OG001
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
OG002
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
OG003
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29.
OG004
Group 1: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 29.
OG005
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
OG006
Group 2: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 57.
OG007
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
OG008
Group 3: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 85.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG0004
OG0016
OG0026
OG003
Primary
Number of Participants With Serious Adverse Events (Groups 1, 2 and 3)
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.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
Up to Day 365
ID
Title
Description
OG000
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5*10^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
OG001
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
OG002
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
Primary
Number of Participants With Immediate Reportable Events (Groups 1, 2 and 3)
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.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
Up to Day 365
ID
Title
Description
OG000
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5*10^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
OG001
Primary
Number of Participants With Solicited Local Adverse Events (Groups 1, 2 and 3)
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.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
7 days post-dose 1 (Day 8)
ID
Title
Description
OG000
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5*10^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
OG001
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
Primary
Number of Participants With Solicited Local Adverse Events (Groups 1, 2 and 3)
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.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
7 days post-dose 2 (Up to Day 92)
ID
Title
Description
OG000
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5*10^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
OG001
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
Primary
Number of Participants With Solicited Systemic Adverse Events (Groups 1, 2 and 3)
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.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
7 days post-dose 1 (Day 8)
ID
Title
Description
OG000
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5*10^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
OG001
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
Primary
Number of Participants With Solicited Systemic Adverse Events (Groups 1, 2 and 3)
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.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
7 days post-dose 2 (Up to Day 92)
ID
Title
Description
OG000
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5*10^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
OG001
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
Secondary
Number of Participants With Unsolicited Adverse Events (Group 4)
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 manner at study visits.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
Up to 28-day post dose 1 (Day 29)
ID
Title
Description
OG000
Group 4: Ad26.ZEBOV
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp on Day 1.
OG001
Group 4: Placebo
Participants received IM injection of placebo Day 1.
Units
Counts
Secondary
Number of Participants With Serious Adverse Events (Group 4)
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.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
Up to Day 180
ID
Title
Description
OG000
Group 4: Ad26.ZEBOV
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp on Day 1.
OG001
Group 4: Placebo
Participants received IM injection of placebo Day 1.
Units
Counts
Participants
OG000
Secondary
Number of Participants With Immediate Reportable Events (Group 4)
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, 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.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
Up to Day 180
ID
Title
Description
OG000
Group 4: Ad26.ZEBOV
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp on Day 1.
OG001
Group 4: Placebo
Participants received IM injection of placebo Day 1.
Secondary
Number of Participants With Solicited Local Adverse Events (Group 4)
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.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
7 days after each vaccination (Up to Day 8)
ID
Title
Description
OG000
Group 4: Ad26.ZEBOV
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp on Day 1.
OG001
Group 4: Placebo
Participants received IM injection of placebo Day 1.
Units
Counts
Participants
Secondary
Number of Participants With Solicited Systemic Adverse Events (Group 4)
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.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
7 days after each vaccination (Up to Day 8)
ID
Title
Description
OG000
Group 4: Ad26.ZEBOV
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp on Day 1.
OG001
Group 4: Placebo
Participants received IM injection of placebo Day 1.
Units
Counts
Participants
Secondary
Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Filovirus Animal Non-Clinical Group (FANG) Enzyme-linked Immunosorbent Assay (ELISA) (Groups 1, 2 and 3)
GMCs of antibodies binding to EBOV GP using FANG ELISA were reported and were measured in ELISA unit per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using FANG ELISA to determine humoral responses following vaccination. For ELISA binding antibody responses, values below the lower limit of quantification (LLOQ) (36.11 ELISA units/mL). The outcome measure was planned to be reported at 21-day post dose 2. Therefore, the results are reported for Group 1, 2 and 3 only.
The per protocol analysis set included all randomized and vaccinated participants, who received both the prime and boost vaccinations (administered within the protocol-defined window), have at least 1 post-vaccination (that is, after the date of vaccination) evaluable immunogenicity sample, and have no major protocol violations influencing the immune response. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
EU/mL
At 21-days post dose 2 (Day 50 for Group 1; Day 78 for Group 2; and Day 106 for Group 3)
ID
Title
Description
OG000
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29.
Time Frame
Up to Day 365
Description
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5*10^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
0
10
0
10
4
10
EG001
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
0
10
1
10
5
10
EG002
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
0
10
0
10
6
10
EG003
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29.
0
112
2
112
41
112
EG004
Group 1: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 29.
0
13
0
13
6
13
EG005
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
0
114
4
114
30
114
EG006
Group 2: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 57.
0
13
1
13
7
13
EG007
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
0
106
5
106
26
106
EG008
Group 3: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 85.
0
18
1
18
8
18
EG009
Group 4: Ad26.ZEBOV
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp on Day 1.
0
13
2
13
6
13
EG010
Group 4: Placebo
Participants received IM injection of placebo Day 1.
0
2
0
2
1
2
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Haemorrhoids
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected112 at risk
EG0040 affected13 at risk
EG0050 affected114 at risk
EG0060 affected13 at risk
EG0070 affected106 at risk
EG0080 affected18 at risk
EG0091 affected13 at risk
EG0100 affected2 at risk
Inguinal hernia
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Food allergy
Immune system disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Hepatitis A
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Human papilloma virus test positive
Investigations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Osteosarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Cerebral venous thrombosis
Nervous system disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Miller Fisher syndrome
Nervous system disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Small fibre neuropathy
Nervous system disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Appendicectomy
Surgical and medical procedures
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Vertigo
Ear and labyrinth disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected112 at risk
EG0041 affected13 at risk
EG0051 affected114 at risk
EG0060 affected13 at risk
EG0070 affected106 at risk
EG0080 affected18 at risk
EG0090 affected13 at risk
EG0100 affected2 at risk
Dental discomfort
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0022 affected10 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Application site bruise
General disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Asthenia
General disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Influenza like illness
General disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Injection site erythema
General disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Injection site pain
General disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Pyrexia
General disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Rhinitis
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected10 at risk
EG0011 affected10 at risk
EG0021 affected10 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Blood creatinine increased
Investigations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected10 at risk
EG0011 affected10 at risk
EG0022 affected10 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Chondropathy
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
OG003
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29.
OG004
Group 1: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 29.
OG005
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
OG006
Group 2: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 57.
OG007
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
OG008
Group 3: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 85.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG003112
OG00413
OG005114
OG00613
OG007106
OG00818
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG0032
OG0040
OG0054
OG0061
OG0075
OG0081
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
OG002
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
OG003
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29.
OG004
Group 1: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 29.
OG005
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
OG006
Group 2: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 57.
OG007
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
OG008
Group 3: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 85.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG003112
OG00413
OG005114
OG00613
OG007106
OG00818
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0052
OG0060
OG0072
OG0080
OG002
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
OG003
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29.
OG004
Group 1: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 29.
OG005
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
OG006
Group 2: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 57.
OG007
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
OG008
Group 3: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 85.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG003112
OG00413
OG005114
OG00613
OG007106
OG00818
Title
Denominators
Categories
Title
Measurements
OG0008
OG0016
OG0028
OG00363
OG0043
OG00565
OG0062
OG00778
OG0084
OG002
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
OG003
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29.
OG004
Group 1: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 29.
OG005
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
OG006
Group 2: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 57.
OG007
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
OG008
Group 3: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 85.
Units
Counts
Participants
OG0008
OG0019
OG0029
OG00391
OG00410
OG00583
OG0067
OG00762
OG00811
Title
Denominators
Categories
Title
Measurements
OG0004
OG0015
OG0028
OG00346
OG0042
OG00549
OG0060
OG00741
OG0080
OG002
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
OG003
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29.
OG004
Group 1: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 29.
OG005
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
OG006
Group 2: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 57.
OG007
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
OG008
Group 3: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 85.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG003112
OG00413
OG005114
OG00613
OG007106
OG00818
Title
Denominators
Categories
Title
Measurements
OG0008
OG00110
OG00210
OG00389
OG0047
OG00584
OG0068
OG00782
OG0087
OG002
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
OG003
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29.
OG004
Group 1: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 29.
OG005
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
OG006
Group 2: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 57.
OG007
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
OG008
Group 3: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 85.
Units
Counts
Participants
OG0008
OG0019
OG0029
OG00391
OG00410
OG00583
OG0067
OG00762
OG00811
Title
Denominators
Categories
Title
Measurements
OG0006
OG0015
OG0025
OG00342
OG0045
OG00536
OG0062
OG00738
OG0084
Participants
OG00013
OG0012
Title
Denominators
Categories
Title
Measurements
OG0006
OG0011
13
OG0012
Title
Denominators
Categories
Title
Measurements
OG0002
OG0010
Units
Counts
Participants
OG00013
OG0012
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG00013
OG0012
Title
Denominators
Categories
Title
Measurements
OG0008
OG0010
OG00013
OG0012
Title
Denominators
Categories
Title
Measurements
OG00011
OG0011
OG001
Group 1: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 29.
OG002
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57.
OG003
Group 2: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 57.
OG004
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85.
OG005
Group 3: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 85.
Units
Counts
Participants
OG00077
OG0017
OG00269
OG0037
OG00448
OG0056
Title
Denominators
Categories
Title
Measurements
OG0004627(3649 to 5867)
OG001NA(NA to 55)Here, 'NA' signifies that Geometric mean and lower limit of 95% CI were not calculated because post dose values were less than LLOQ (36.11 ELISA units/mL).
OG00210131(8554 to 11999)
OG003NA(NA to NA)Here, 'NA' signifies that Geometric mean and CI were not calculated because post dose values were less than LLOQ (36.11 ELISA units/mL).
OG00411312(9072 to 14106)
OG005NA(NA to NA)Here, 'NA' signifies that Geometric mean and CI were not calculated because post dose values were less than LLOQ (36.11 ELISA units/mL).