Safety, Tolerability and Immunogenicity Study of 2-dose H... | NCT02598388 | Trialant
NCT02598388
Sponsor
Janssen Vaccines & Prevention B.V.
Status
Completed
Last Update Posted
Feb 4, 2025Actual
Enrollment
578Actual
Phase
Phase 2
Conditions
Hemorrhagic Fever, Ebola
Interventions
Ad26.ZEBOV
MVA-BN-Filo
Placebo
Countries
United States
Kenya
Mozambique
Nigeria
Tanzania
Uganda
Protocol Section
Identification Module
NCT ID
NCT02598388
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR108062
Secondary IDs
ID
Type
Description
Link
VAC52150EBL2003
Other Identifier
Janssen Vaccines & Prevention B.V.
Brief Title
Safety, Tolerability and Immunogenicity Study of 2-dose Heterologous Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo
Official Title
A Randomized, Observer-blind, Placebo-controlled, Two-part, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo
Acronym
Not provided
Organization
Janssen Vaccines & Prevention B.V.INDUSTRY
Status Module
Record Verification Date
Jan 2025
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
Dec 10, 2015Actual
Primary Completion Date
Dec 12, 2018Actual
Completion Date
Dec 12, 2018Actual
First Submitted Date
Nov 4, 2015
First Submission Date that Met QC Criteria
Nov 4, 2015
First Posted Date
Nov 5, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 10, 2021
Results First Submitted that Met QC Criteria
Jan 27, 2022
Results First Posted Date
Feb 18, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Dec 11, 2019
Certification/Extension First Submitted that Passed QC Review
Dec 11, 2019
Certification/Extension First Posted Date
Dec 13, 2019Actual
Last Update Submitted Date
Jan 31, 2025
Last Update Posted Date
Feb 4, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen Vaccines & Prevention B.V.INDUSTRY
Collaborators
Name
Class
Walter Reed Army Institute of Research (WRAIR)
FED
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
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 assess the safety, tolerability and immunogenicity of different vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens in healthy and in HIV-infected adults.
Detailed Description
This is a randomized, observer-blind, placebo-controlled, parallel-group, multicenter, 2-part, Phase 2 study of Ad26.ZEBOV and MVA-BN-Filo in healthy and HIV infected adults. In part 1, dose 1 vaccination with MVA-Bn-Filo will be followed by dose 2 vaccination with Ad26 14 days later in the US. In part 2, two regimens will be investigated. The first regimen will be Ad26 dose 1 vaccination followed by MVA-BN-Filo dose 2, 28 days later and the second regimen will be MVA-BN-Filo dose 1 vaccination followed by Ad26.ZEBOV dose 2, 14 days later in Africa. The study consists of a Screening phase of up to 8 weeks (starting from the moment the participants signs the ICF), a Vaccination Phase, in which participants will be vaccinated at baseline (Day 1) followed by a dose 2 vaccination on Day 15 or 29, and a post-dose 2 follow-up phase of maximum 1 year post-dose 2 vaccination. Upon completion of 6-month post dose 2 visit those participants who received active vaccine will enter long-term follow-up until the 1 year post dose 2 vaccination visit to assess long-term safety and immunogenicity.
Conditions Module
Conditions
Hemorrhagic Fever, Ebola
Keywords
Healthy
Vaccine
Ebola viruses
Ebola virus disease (EVD)
Filoviruses
Hemorrhagic fever
Monovalent vaccine
Human adenovirus serotype 26 (Ad26) encoding the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV)
Modified Vaccinia Virus Ankara - Bavarian Nordic (MVA-BN) Filo-vector
Safety
Immunogenicity
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
578Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1 (US Participants)
Experimental
Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.ZEBOV or placebo on Day 15.
Biological: Ad26.ZEBOV
Biological: MVA-BN-Filo
Biological: Placebo
Part 2 Group 1 (African Participants)
Experimental
Participants will receive Ad26.ZEBOV or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 29.
Biological: Ad26.ZEBOV
Biological: MVA-BN-Filo
Biological: Placebo
Part 2 Group 2 (African Participants)
Experimental
Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.ZEBOV or placebo on Day 15.
Biological: Ad26.ZEBOV
Biological: MVA-BN-Filo
Biological: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ad26.ZEBOV
Biological
One 0.5 mL intramuscular (IM) injection of (5x10*10 viral particles).
Part 1 (US Participants)
Part 2 Group 1 (African Participants)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1, Part 2 (Group 2): Number of Participants With Unsolicited Adverse Events
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. 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. As per planned analysis, the data from Parts 1 and 2 (Group 2) of the study was pooled (that is, 14-day interval regimen) and presented separately for the healthy and HIV-infected cohorts.
Up to 28 days post each dose (up to Day 43)
Part 2 (Group 1): Number of Participants With Unsolicited Adverse Events
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. 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 28 days post dose 2 visit (up to Day 57)
Part 1, Part 2 (Group 2): Number of Participants With Serious Adverse Events (SAEs)
A SAE is an adverse event 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. As per planned analysis, the data from Parts 1 and 2 (Group 2) of the study was pooled (that is, 14-day interval regimen) and presented separately for the healthy and HIV-infected cohorts.
Up to 1 year post dose 2 (up to Day 380)
Part 2 (Group 1): Number of Participants With SAEs
A SAE is an adverse event 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.
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Adverse Events
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. As per planned analysis, the data from Parts 1 and 2 (Group 2) of the study was pooled (that is, 14-day interval regimen) and presented separately for the healthy and HIV-infected cohorts. This outcome measure was planned to compare the safety (unsolicited AEs, solicited local and solicited systemic AEs) of Ad26.ZEBOV/MVA-BN-Filo and MVA-BN-Filo/Ad26.ZEBOV regimens in healthy and HIV-infected participants. Therefore, placebo arm is not reported.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participant must be healthy in the Investigator's clinical judgment on the basis of medical history, physical examination and vital signs performed at Screening
Participant must be healthy on the basis of clinical laboratory tests and electrocardiogram (ECG) (only in participants >50 years) performed at Screening. If the results of the laboratory screening tests and ECG are outside the institutional 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
A woman of childbearing potential must have a negative urine β-human chorionic gonadotropin [beta-hCG] pregnancy test at Screening and a negative urine [beta-hCG] pregnancy test immediately prior to each study vaccine administration
A man who is sexually active with a woman of childbearing potential must be willing to use condoms for sexual intercourse beginning prior to dose 1 vaccination until at least 3 months after the dose 2 vaccination, unless a vasectomy was performed more than 1 year prior to Screening
Participant must pass the test of understanding (TOU)
Additional Inclusion Criteria for HIV-infected participants a) participants must have a positive HIV-1 and/or -2 serology test within 6 months of screening, including the day of screening; b) participants must have a Screening CD4+ cell count >200 cells/microliter (mcL); c) in part 1, all participants must be on a stable highly active antiretroviral therapy (HAART) regimen for 4 weeks prior to Screening, in part 2 participants with screening CD4+ cell count <350 cells/mcL must also be on a stable HAART regimen for 4 weeks prior to Screening
Exclusion Criteria:
Has received any candidate Ebola vaccine
Diagnosed with Ebola virus disease, or prior exposure to EBOV, including travel to epidemic Ebola areas less than 1 month prior to Screening
Has received any experimental candidate Ad26- or MVA-based vaccine in the past or received any other investigational drug or investigational vaccine or used an invasive investigational medical device within 3 months prior to Screening
Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products
Presence of significant conditions (eg, history of seizure disorders, (auto)immune disease or deficiency, any spleen disease, active malignancy, ongoing tuberculosis treatment, other systemic infections) or clinically significant findings during screening of medical history, ECG (only in participants >50 years), physical examination, vital signs or laboratory testing for which, in the opinion of the investigator, participation would not be in the best interest of the participants (eg, compromise the safety or well-being) or that could prevent, limit, or confound the protocol-specified assessments
Ake JA, Paolino K, Hutter JN, Cicatelli SB, Eller LA, Eller MA, Costanzo MC, Paquin-Proulx D, Robb ML, Tran CL, Anova L, Jagodzinski LL, Ward LA, Kilgore N, Rusnak J, Bounds C, Badorrek CS, Hooper JW, Kwilas SA, Ilsbroux I, Anumendem DN, Gaddah A, Shukarev G, Bockstal V, Luhn K, Douoguih M, Robinson C. Safety and Immunogenicity of an Accelerated Ebola Vaccination Schedule in People with and without Human Immunodeficiency Virus: A Randomized Clinical Trial. Vaccines (Basel). 2024 May 4;12(5):497. doi: 10.3390/vaccines12050497.
Out of 578 randomized participants, 574 received at least one dose of study vaccine.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: MVA-BN-Filo and Ad26.ZEBOV (Healthy Participants)
Healthy participants received an intramuscular (IM) injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.
FG001
Part 1: Placebo (Healthy Participants)
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
Prot
Yes
No
No
Study Protocol
Sep 18, 2017
Dec 10, 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
MeSH Terms
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
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
Part 2 Group 2 (African Participants)
MVA-BN-Filo
Biological
One 0.5 mL IM injection of (1x10*8 infectious units).
Part 1 (US Participants)
Part 2 Group 1 (African Participants)
Part 2 Group 2 (African Participants)
Placebo
Biological
One 0.5 mL IM injection of 0.9 percent (%) saline.
Part 1 (US Participants)
Part 2 Group 1 (African Participants)
Part 2 Group 2 (African Participants)
Up to 1 year post dose 2 (up to Day 394)
Part 1, Part 2 (Group 2): Number of Participants With Immediate Reportable Events (IREs)
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: 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 1 year post dose 2 (up to Day 380)
Part 2 (Group 1): Number of Participants With IREs
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: 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 1 year post dose 2 (up to Day 394)
Parts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) 7 Days Post First Vaccination
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. As per planned analysis, the data from Parts 1 and 2 (Group 2) of the study was pooled (that is, 14-day interval regimen) and presented separately for the healthy and HIV-infected cohorts.
7 days post dose 1 (up to Day 8)
Part 1, Part 2 (Group 2): Number of Participants With Solicited Local AEs 7 Days Post Second Vaccination
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 second vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site. As per planned analysis, the data from Parts 1 and 2 (Group 2) of the study was pooled (that is, 14-day interval regimen) and presented separately for the healthy and HIV-infected cohorts.
7 days post dose 2 (up to Day 22)
Part 2 (Group 1): Number of Participants With Solicited Local AEs 7 Days Post Second Vaccination
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 second 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 36)
Parts 1 and 2: Number of Participants With Solicited Systemic Adverse Events 7 Days Post First Vaccination
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. As per planned analysis, the data from Parts 1 and 2 (Group 2) of the study was pooled (that is, 14-day interval regimen) and presented separately for the healthy and HIV-infected cohorts.
7 days post dose 1 (up to Day 8)
Part 1, Part 2 (Group 2): Number of Participants With Solicited Systemic AEs 7 Days Post Second Vaccination
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. As per planned analysis, the data from Parts 1 and 2 (Group 2) of the study was pooled (that is, 14-day interval regimen) and presented separately for the healthy and HIV-infected cohorts.
7 days post dose 2 (up to Day 22)
Part 2 (Group 1): Number of Participants With Solicited Systemic AEs 7 Days Post Second Vaccination
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 36)
Part 1, Part 2 (Group 2): 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)
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. A sample was considered positive, if the value was above the lower limit of quantification (LLOQ), that is, 36.11 ELISA units/mL. As per planned analysis, the data from Parts 1 and 2 (Group 2) of the study was pooled (that is, 14-day interval regimen) and presented separately for the healthy and HIV-infected cohorts.
21-days post dose 2 (up to Day 36)
Part 2 (Group 1): GMCs of Binding Antibody Levels Against EBOV GP Measured Using FANG ELISA
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. A sample was considered positive, if the value was above the LLOQ, that is, 36.11 ELISA units/mL.
21-days post dose 2 (Day 50)
Solicited AEs: Up to 7 days post each vaccination (Up to Day 36); Unsolicited AEs: Up to 28 days post each vaccination (Up to Day 57)
Kericho
Kenya
Kisumu
Kenya
Maputo
Mozambique
Abuja
Nigeria
Mbeya
Tanzania
Kampala
Uganda
Derived
Mwesigwa B, Sawe F, Oyieko J, Mwakisisile J, Viegas E, Akintunde GA, Kosgei J, Kokogho A, Ntinginya N, Jani I, Shukarev G, Hooper JW, Kwilas SA, Ward LA, Rusnak J, Bounds C, Overman R, Badorrek CS, Eller LA, Eller MA, Polyak CS, Moodley A, Tran CL, Costanzo MC, Leggat DJ, Paquin-Proulx D, Naluyima P, Anumendem DN, Gaddah A, Luhn K, Hendriks J, McLean C, Douoguih M, Kibuuka H, Robb ML, Robinson C, Ake JA. Safety and Immunogenicity of Accelerated Heterologous 2-Dose Ebola Vaccine Regimens in Adults With and Without HIV in Africa. Clin Infect Dis. 2024 Oct 15;79(4):888-900. doi: 10.1093/cid/ciae215.
Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.
FG002
Part 1: MVA-BN-Filo and Ad26.ZEBOV (HIV-infected Participants)
Human immunodeficiency virus (HIV) infected participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.
FG003
Part 1: Placebo (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.
FG004
Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants)
Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
FG005
Part 2 (Group 1): Placebo (Healthy Participants)
Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
FG006
Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
FG007
Part 2 (Group 1): Placebo (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
FG008
Part 2 (Group 2): MVA-BN-Filo and Ad26.ZEBOV (Healthy Participants)
Healthy participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.
FG009
Part 2 (Group 2): Placebo (Healthy Participants)
Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.
FG010
Part 2 (Group 2): MVA-BN-Filo and Ad26.ZEBOV (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.
FG011
Part 2 (Group 2): Placebo (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.
FG00040 subjects
FG00110 subjects
FG00220 subjects
FG0035 subjects
FG004161 subjects
FG00539 subjects
FG006161 subjects
FG00739 subjects
FG00839 subjects
FG00910 subjects
FG01040 subjects
FG01110 subjects
COMPLETED
FG00039 subjects
FG00110 subjects
FG00218 subjects
FG0035 subjects
FG004151 subjects
FG00538 subjects
FG006156 subjects
FG00738 subjects
FG00839 subjects
FG0099 subjects
FG01039 subjects
FG01110 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG00410 subjects
FG0051 subjects
FG0065 subjects
FG0071 subjects
FG0080 subjects
FG0091 subjects
FG0101 subjects
FG0110 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0045 subjects
FG0051 subjects
FG0062 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: MVA-BN-Filo and Ad26.ZEBOV (Healthy Participants)
Healthy participants received an intramuscular (IM) injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.
BG001
Part 1: Placebo (Healthy Participants)
Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.
BG002
Part 1: MVA-BN-Filo and Ad26.ZEBOV (HIV-infected Participants)
Human immunodeficiency virus (HIV) infected participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.
BG003
Part 1: Placebo (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.
BG004
Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants)
Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
BG005
Part 2 (Group 1): Placebo (Healthy Participants)
Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
BG006
Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
BG007
Part 2 (Group 1): Placebo (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
BG008
Part 2 (Group 2): MVA-BN-Filo and Ad26.ZEBOV (Healthy Participants)
Healthy participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.
BG009
Part 2 (Group 2): Placebo (Healthy Participants)
Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.
BG010
Part 2 (Group 2): MVA-BN-Filo and Ad26.ZEBOV (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.
BG011
Part 2 (Group 2): Placebo (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00040
BG00110
BG00220
BG0035
BG004161
BG00539
BG006161
BG00739
BG00839
BG00910
BG01040
BG01110
BG012574
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
BG00042± 14.42
BG00147.3± 11.84
BG00246.7± 12.89
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00018
BG0017
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0003
BG0010
BG002
Race (NIH/OMB)
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
KENYA
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
Part 1, Part 2 (Group 2): Number of Participants With Unsolicited Adverse Events
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. 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. As per planned analysis, the data from Parts 1 and 2 (Group 2) of the study was pooled (that is, 14-day interval regimen) and presented separately for the healthy and HIV-infected cohorts.
Safety set was based on full analysis set (FAS) which included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
Up to 28 days post each dose (up to Day 43)
ID
Title
Description
OG000
Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV
Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.
OG001
Healthy (Part 1, Part 2; Group 2): Placebo
Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.
OG002
HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV
Human immunodeficiency virus (HIV)- infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.
OG003
HIV-infected (Part 1, Part 2; Group 2): Placebo
HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.
Units
Counts
Participants
OG00079
OG00120
OG00260
OG003
Title
Denominators
Categories
Title
Measurements
OG00033
OG00110
OG00232
OG003
Primary
Part 2 (Group 1): Number of Participants With Unsolicited Adverse Events
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. 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.
Safety set was based on FAS which included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
Up to 28 days post dose 2 visit (up to Day 57)
ID
Title
Description
OG000
Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants)
Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
OG001
Part 2 (Group 1): Placebo (Healthy Participants)
Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
OG002
Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants)
Primary
Part 1, Part 2 (Group 2): Number of Participants With Serious Adverse Events (SAEs)
A SAE is an adverse event 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. As per planned analysis, the data from Parts 1 and 2 (Group 2) of the study was pooled (that is, 14-day interval regimen) and presented separately for the healthy and HIV-infected cohorts.
Safety set was based on FAS which included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
Up to 1 year post dose 2 (up to Day 380)
ID
Title
Description
OG000
Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV
Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.
OG001
Healthy (Part 1, Part 2; Group 2): Placebo
Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.
Primary
Part 2 (Group 1): Number of Participants With SAEs
A SAE is an adverse event 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.
Safety set was based on FAS which included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
Up to 1 year post dose 2 (up to Day 394)
ID
Title
Description
OG000
Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants)
Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
OG001
Part 2 (Group 1): Placebo (Healthy Participants)
Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
OG002
Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
Primary
Part 1, Part 2 (Group 2): Number of Participants With Immediate Reportable Events (IREs)
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: 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.
Safety set was based on FAS which included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations. As per planned analysis, the data from Parts 1 and 2 (Group 2) of the study was pooled (that is, 14-day interval regimen) and presented separately for the healthy and HIV-infected cohorts.
Posted
Count of Participants
Participants
Up to 1 year post dose 2 (up to Day 380)
ID
Title
Description
OG000
Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV
Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.
Primary
Part 2 (Group 1): Number of Participants With IREs
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: 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.
Safety set was based on FAS which included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
Up to 1 year post dose 2 (up to Day 394)
ID
Title
Description
OG000
Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants)
Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
OG001
Part 2 (Group 1): Placebo (Healthy Participants)
Primary
Parts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) 7 Days Post First Vaccination
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. As per planned analysis, the data from Parts 1 and 2 (Group 2) of the study was pooled (that is, 14-day interval regimen) and presented separately for the healthy and HIV-infected cohorts.
Safety set was based on FAS which included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
7 days post dose 1 (up to Day 8)
ID
Title
Description
OG000
Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV
Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.
OG001
Healthy (Part 1, Part 2; Group 2): Placebo
Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.
Primary
Part 1, Part 2 (Group 2): Number of Participants With Solicited Local AEs 7 Days Post Second Vaccination
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 second vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site. As per planned analysis, the data from Parts 1 and 2 (Group 2) of the study was pooled (that is, 14-day interval regimen) and presented separately for the healthy and HIV-infected cohorts.
Safety set was based on FAS which included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations. Here, N (number of participants analyzed) signifies number of participants that were evaluable for this outcome measure.
Posted
Count of Participants
Participants
7 days post dose 2 (up to Day 22)
ID
Title
Description
OG000
Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV
Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.
OG001
Healthy (Part 1, Part 2; Group 2): Placebo
Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.
Primary
Part 2 (Group 1): Number of Participants With Solicited Local AEs 7 Days Post Second Vaccination
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 second vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Safety set was based on FAS which included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations. Here, N (number of participants analyzed) signifies number of participants that were evaluable for this outcome measure.
Posted
Count of Participants
Participants
7 days post dose 2 (up to Day 36)
ID
Title
Description
OG000
Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants)
Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
OG001
Part 2 (Group 1): Placebo (Healthy Participants)
Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
OG002
Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants)
Primary
Parts 1 and 2: Number of Participants With Solicited Systemic Adverse Events 7 Days Post First Vaccination
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. As per planned analysis, the data from Parts 1 and 2 (Group 2) of the study was pooled (that is, 14-day interval regimen) and presented separately for the healthy and HIV-infected cohorts.
Safety set was based on FAS which included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
7 days post dose 1 (up to Day 8)
ID
Title
Description
OG000
Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV
Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.
OG001
Healthy (Part 1, Part 2; Group 2): Placebo
Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.
Primary
Part 1, Part 2 (Group 2): Number of Participants With Solicited Systemic AEs 7 Days Post Second Vaccination
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. As per planned analysis, the data from Parts 1 and 2 (Group 2) of the study was pooled (that is, 14-day interval regimen) and presented separately for the healthy and HIV-infected cohorts.
Safety set was based on FAS which included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations. Here, N (number of participants analyzed) signifies number of participants that were evaluable for this outcome measure.
Posted
Count of Participants
Participants
7 days post dose 2 (up to Day 22)
ID
Title
Description
OG000
Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV
Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.
OG001
Healthy (Part 1, Part 2; Group 2): Placebo
Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.
Primary
Part 2 (Group 1): Number of Participants With Solicited Systemic AEs 7 Days Post Second Vaccination
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.
Safety set was based on FAS which included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations. Here, N (number of participants analyzed) signifies number of participants that were evaluable for this outcome measure.
Posted
Count of Participants
Participants
7 days post dose 2 (up to Day 36)
ID
Title
Description
OG000
Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants)
Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
OG001
Part 2 (Group 1): Placebo (Healthy Participants)
Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
OG002
Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants)
Primary
Part 1, Part 2 (Group 2): 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)
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. A sample was considered positive, if the value was above the lower limit of quantification (LLOQ), that is, 36.11 ELISA units/mL. As per planned analysis, the data from Parts 1 and 2 (Group 2) of the study was pooled (that is, 14-day interval regimen) and presented separately for the healthy and HIV-infected cohorts.
The per protocol analysis set included all randomized and vaccinated participants, who received both the dose 1 and dose 2 vaccinations (administered within the protocol-defined visit window), had at least 1 post-vaccination (that is, after the date of vaccination) evaluable immunogenicity sample, and had no major protocol violations influencing the immune responses. Here, N (number of participants analyzed) signifies number of participants that were evaluable for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
EU/mL
21-days post dose 2 (up to Day 36)
ID
Title
Description
OG000
Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV
Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.
Primary
Part 2 (Group 1): GMCs of Binding Antibody Levels Against EBOV GP Measured Using FANG ELISA
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. A sample was considered positive, if the value was above the LLOQ, that is, 36.11 ELISA units/mL.
The per protocol analysis set included all randomized and vaccinated participants, who received both the dose 1 and dose 2 vaccinations (administered within the protocol-defined visit window), had at least 1 post-vaccination (that is, after the date of vaccination) evaluable immunogenicity sample, and had no major protocol violations influencing the immune responses. Here, N (number of participants analyzed) signifies number of participants that were evaluable for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
EU/mL
21-days post dose 2 (Day 50)
ID
Title
Description
OG000
Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants)
Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
OG001
Part 2 (Group 1): Placebo (Healthy Participants)
Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
Secondary
Number of Participants With Adverse Events
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. As per planned analysis, the data from Parts 1 and 2 (Group 2) of the study was pooled (that is, 14-day interval regimen) and presented separately for the healthy and HIV-infected cohorts. This outcome measure was planned to compare the safety (unsolicited AEs, solicited local and solicited systemic AEs) of Ad26.ZEBOV/MVA-BN-Filo and MVA-BN-Filo/Ad26.ZEBOV regimens in healthy and HIV-infected participants. Therefore, placebo arm is not reported.
Safety set was based on FAS which included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
Solicited AEs: Up to 7 days post each vaccination (Up to Day 36); Unsolicited AEs: Up to 28 days post each vaccination (Up to Day 57)
ID
Title
Description
OG000
Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV
Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo as prime vaccine on Day 1 followed by IM injection of single dose Ad26.ZEBOV as booster vaccine at Day 15.
OG001
HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV
HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo as prime vaccine on Day 1 followed by IM injection of single dose Ad26.ZEBOV as booster vaccine at Day 15.
Time Frame
Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1)
Description
Safety set included all participants who were randomized and received at least 1 dose of study vaccine, 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
Part 1: MVA-BN-Filo and Ad26.ZEBOV (Healthy Participants)
Healthy participants received an intramuscular (IM) injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.
0
40
1
40
11
40
EG001
Part 1: Placebo (Healthy Participants)
Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.
0
10
1
10
5
10
EG002
Part 1: MVA-BN-Filo and Ad26.ZEBOV (HIV-infected Participants)
Human immunodeficiency virus (HIV) infected participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.
0
20
1
20
11
20
EG003
Part 1: Placebo (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.
0
5
1
5
0
5
EG004
Part 2 (Group 2): MVA-BN-Filo and Ad26.ZEBOV (Healthy Participants)
Healthy participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.
0
39
0
39
12
39
EG005
Part 2 (Group 2): Placebo (Healthy Participants)
Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.
0
10
0
10
5
10
EG006
Part 2 (Group 2): MVA-BN-Filo and Ad26.ZEBOV (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.
0
40
2
40
13
40
EG007
Part 2 (Group 2): Placebo (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.
0
10
0
10
3
10
EG008
Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants)
Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
0
161
1
161
53
161
EG009
Part 2 (Group 1): Placebo (Healthy Participants)
Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
0
39
1
39
15
39
EG010
Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
0
161
2
161
51
161
EG011
Part 2 (Group 1): Placebo (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
0
39
0
39
11
39
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG0030 affected5 at risk
EG0040 affected39 at risk
EG0050 affected10 at risk
EG0060 affected40 at risk
EG0070 affected10 at risk
EG0080 affected161 at risk
EG0090 affected39 at risk
EG0101 affected161 at risk
EG0110 affected39 at risk
Peptic Ulcer
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Anaphylactic Reaction
Immune system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0011 affected10 at risk
EG0020 affected20 at risk
EG003
Appendicitis Perforated
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Malaria
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Postoperative Wound Infection
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Staphylococcal Osteomyelitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Typhoid Fever
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Soft Tissue Injury
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Cervical Cord Compression
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Panic Attack
Psychiatric disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0021 affected20 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0002 affected40 at risk
EG0010 affected10 at risk
EG0023 affected20 at risk
EG0030 affected5 at risk
EG0040 affected39 at risk
EG0050 affected10 at risk
EG0060 affected40 at risk
EG0070 affected10 at risk
EG0082 affected161 at risk
EG0090 affected39 at risk
EG0103 affected161 at risk
EG0111 affected39 at risk
Eosinophilia
Blood and lymphatic system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0002 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Dental Caries
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected40 at risk
EG0010 affected10 at risk
EG0021 affected20 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0021 affected20 at risk
EG003
Fatigue
General disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Injection Site Erosion
General disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0011 affected10 at risk
EG0020 affected20 at risk
EG003
Body Tinea
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0021 affected20 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Malaria
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Otitis Media
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0022 affected20 at risk
EG003
Rash Pustular
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Rhinitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0002 affected40 at risk
EG0010 affected10 at risk
EG0021 affected20 at risk
EG003
Apheresis Related Complication
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0003 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Meniscus Injury
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0021 affected20 at risk
EG003
Muscle Strain
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0011 affected10 at risk
EG0020 affected20 at risk
EG003
Procedural Pain
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0021 affected20 at risk
EG003
Soft Tissue Injury
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0021 affected20 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0011 affected10 at risk
EG0020 affected20 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0002 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Dizziness
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0021 affected20 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0021 affected20 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Presyncope
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected40 at risk
EG0010 affected10 at risk
EG0021 affected20 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0011 affected10 at risk
EG0020 affected20 at risk
EG003
Rhinitis Allergic
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected10 at risk
EG0020 affected20 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected40 at risk
EG0012 affected10 at risk
EG0020 affected20 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.
HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
OG003
Part 2 (Group 1): Placebo (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
Units
Counts
Participants
OG000161
OG00139
OG002161
OG00339
Title
Denominators
Categories
Title
Measurements
OG00083
OG00121
OG00278
OG00315
OG002
HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV
HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.
OG003
HIV-infected (Part 1, Part 2; Group 2): Placebo
HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.
Units
Counts
Participants
OG00079
OG00120
OG00260
OG00315
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0023
OG0031
OG003
Part 2 (Group 1): Placebo (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
Units
Counts
Participants
OG000161
OG00139
OG002161
OG00339
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0022
OG0030
OG001
Healthy (Part 1, Part 2; Group 2): Placebo
Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.
OG002
HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV
HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.
OG003
HIV-infected (Part 1, Part 2; Group 2): Placebo
HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.
Units
Counts
Participants
OG00079
OG00120
OG00260
OG00315
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
OG002
Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
OG003
Part 2 (Group 1): Placebo (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
Units
Counts
Participants
OG000161
OG00139
OG002161
OG00339
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG002
HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV
HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.
OG003
HIV-infected (Part 1, Part 2; Group 2): Placebo
HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.
OG004
Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants)
Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
OG005
Part 2 (Group 1): Placebo (Healthy Participants)
Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
OG006
Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
OG007
Part 2 (Group 1): Placebo (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
Units
Counts
Participants
OG00079
OG00120
OG00260
OG00315
OG004161
OG00539
OG006161
OG00739
Title
Denominators
Categories
Title
Measurements
OG00046
OG0015
OG00234
OG0033
OG00471
OG00510
OG00675
OG0077
OG002
HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV
HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.
OG003
HIV-infected (Part 1, Part 2; Group 2): Placebo
HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.
Units
Counts
Participants
OG00078
OG00120
OG00258
OG00314
Title
Denominators
Categories
Title
Measurements
OG00044
OG0014
OG00233
OG0030
HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
OG003
Part 2 (Group 1): Placebo (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
Units
Counts
Participants
OG000159
OG00137
OG002160
OG00338
Title
Denominators
Categories
Title
Measurements
OG00082
OG0017
OG00264
OG0037
OG002
HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV
HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.
OG003
HIV-infected (Part 1, Part 2; Group 2): Placebo
HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.
OG004
Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants)
Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
OG005
Part 2 (Group 1): Placebo (Healthy Participants)
Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
OG006
Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
OG007
Part 2 (Group 1): Placebo (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
Units
Counts
Participants
OG00079
OG00120
OG00260
OG00315
OG004161
OG00539
OG006161
OG00739
Title
Denominators
Categories
Title
Measurements
OG00039
OG00110
OG00237
OG0037
OG004109
OG00524
OG00697
OG00718
OG002
HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV
HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.
OG003
HIV-infected (Part 1, Part 2; Group 2): Placebo
HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.
Units
Counts
Participants
OG00078
OG00120
OG00258
OG00314
Title
Denominators
Categories
Title
Measurements
OG00045
OG0018
OG00235
OG0034
HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
OG003
Part 2 (Group 1): Placebo (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
Units
Counts
Participants
OG000159
OG00137
OG002160
OG00338
Title
Denominators
Categories
Title
Measurements
OG00083
OG00120
OG00280
OG00310
OG001
Healthy (Part 1, Part 2; Group 2): Placebo
Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.
OG002
HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV
HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.
OG003
HIV-infected (Part 1, Part 2; Group 2): Placebo
HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.
Units
Counts
Participants
OG00068
OG00118
OG00256
OG00313
Title
Denominators
Categories
Title
Measurements
OG0005733(4245 to 7742)
OG00140(NA to 112)Here, 'NA' signifies that lower limit of calculated 95% CI was less than LLOQ.
OG0022325(1632 to 3313)
OG003NA(NA to 38)Here, 'NA' signifies that geometric mean and lower limit of calculated 95% CI was less than LLOQ.
OG002
Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
OG003
Part 2 (Group 1): Placebo (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
Units
Counts
Participants
OG000151
OG00134
OG002155
OG00336
Title
Denominators
Categories
Title
Measurements
OG0006037(4996 to 7297)
OG001NA(NA to NA)Here, "NA" signifies that calculated Geometric mean and the limits of the 95% CI were less than LLOQ
OG0022939(2316 to 3729)
OG003NA(NA to NA)Here, "NA" signifies that calculated Geometric mean and the limits of the 95% CI were less than LLOQ
OG002
Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants)
Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.
OG003
Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants)
HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.