Hemorrhagic Fever, Ebola
Conditions
Keywords
Healthy, Vaccine, Ebola viruses, Ebola virus disease (EVD), Filoviruses, Hemorrhagic fever, Monovalent vaccine, Human adenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV), Modified Vaccinia Virus Ankara - Bavarian Nordic (MVA-BN) Filo-vector, Safety, Immunogenicity, Inserm, Centre Muraz
Brief summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of three heterologous prime-boost regimens for Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo. The study will include healthy adults and elderly participants, HIV infected participants and healthy children in 2 age strata.
Detailed description
This is a randomized, observer-blind, placebo-controlled, parallel-group, multicenter, Phase 2 study evaluating the safety, tolerability and immunogenicity of 3 heterologous prime-boost regimens using Ad26.ZEBOV as prime and MVA-BN-Filo as boost vaccination, administered at 28-, 56- and 84-day (Group 1, 2 and 3 as above) intervals, in healthy adults and elderly participants. A 28- and 56-day (Groups 1 and 2, as above) schedule will be evaluated in HIV-infected participants and in healthy children in 2 age strata. The study consists of a screening phase of up to 8 weeks, a vaccination phase in which participants will be vaccinated at baseline (Day 1) followed by a boost vaccination on Day 29, 57 or 85, a post-vaccination phase and long-term follow-up phase until Day 365. Participants in Cohort 1 substudy (Group 1 and 2) who received Ad26.ZEBOV and MVA-BN-Filo (at selected sites) will receive Ad26.ZEBOV as third vaccination and who received placebo will receive placebo as third vaccination (at least 1 year post prime vaccination). All participants within a cohort will be followed in a blinded manner by the site until the last subject in that cohort has completed the study. This study will be conducted in Africa and the enrollment will take place sequentially in three cohorts: the first cohort will consist of healthy participants (18 - 70 years); the second cohort (2a) will include HIV-infected participants (18 to 50 years) and healthy children 12 to 17 years (cohort 2b); the third cohort will include children aged 4 to 11 years inclusive will be enrolled. Within each cohort, participants will be randomized in a 5:1 ratio to receive active vaccine versus placebo. Safety evaluations will include assessments of adverse events, an electrocardiogram (ECG) for adult participants at screening, physical examination, vital signs (blood pressure, pulse/heart rate, body temperature), clinical laboratory and pregnancy testing. An independent data monitoring committee (IDMC) will be established to monitor data on a regular basis to ensure the continuing safety of the participants enrolled in the study.
Interventions
BIOLOGICALAd26.ZEBOV
One 0.5 mL intramuscular (IM) injection of (5x10\*10 viral particles)
BIOLOGICALMVA-BN-Filo
One 0.5 mL IM injection of (1x10\*8 infectious units)
BIOLOGICALPlacebo
One 0.5 mL IM injection of 0.9% saline
Sponsors
EBOVAC2 Consortium
Institut National de la Santé Et de la Recherche Médicale, France
Centre Muraz
Janssen Vaccines & Prevention B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Criteria for healthy adults and elderly participants: * Participant must be healthy in the investigator's clinical judgment on the basis of clinical laboratory tests, medical history, ECG, physical examination and vital signs performed at screening. Participants with hemoglobin values outside the local laboratory reference ranges may be included if the hemoglobin is above the age/gender specific limits * Female participants of childbearing potential must use adequate birth control measures, must have a negative pregnancy test at screening and immediately prior to each study vaccination * A man who is sexually active with a woman of childbearing potential must be willing to use condoms for sexual intercourse beginning prior to enrollment, unless a vasectomy was performed more than 1 year prior to screening * Participant must pass the test of understanding (TOU) * Participant must be available and willing to participate for the duration of the study visits and follow-up, provide verifiable identification, and have a means to be contacted Additional Inclusion Criteria HIV-infected Participants * Participant must be between 18 to 50 years of age and must have a documented HIV-infection for at least 6 months prior to screening * Participant must be on a stable 3 drug regimen of Highly Active Antiretroviral Therapy for at least 4 weeks prior to screening and having a CD4 positive cell count of \>350 cells/microliter. Also participant must be in an otherwise reasonable good medical condition Additional Inclusion Criteria Children Participants * Parent/legal guardian must pass the TOU before signing the inform consent form. Informed assent must be obtained from adolescents and older children, depending on local regulations and practice * Pediatric participant's age on the day of randomization must be within one of the 2 age strata: 12-17 years or 4-11 years (all ages inclusive) * Pediatric participants must have received all routine immunizations appropriate for his or her age as reported by the parent(s)/legal guardian, according to local routine vaccination schedules
Exclusion criteria
* Diagnosed with Ebola virus disease or previously exposed to Ebola virus including travel to epidemic Ebola areas less than 1 month prior to screening * Having received any candidate Ebola vaccine or any experimental candidate Ad26- or MVA-based vaccine in the past * Having HIV type 1 or type 2 infection (for healthy adults/elderly/children) * Pediatric participants with weight-per-height below 10th percentile according to the Centers for Disease Control and Prevention (CDC) growth charts (4- to 11-year-olds) * A woman who is pregnant, breast-feeding or planning to become pregnant while enrolled in the study or within at least 3 months after the prime vaccination or up to 1 month after the boost vaccination (whichever takes longer) or within at least 3 months after the third vaccination * For HIV+ adults, no AIDS-defining illnesses
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Systemic Adverse Events (Day 372) | Up to 7 days post-dose 3 (Day 372) | 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. |
| Number of Participants With Solicited Systemic Adverse Events (56-Day Interval) | Up 7 days post-dose 2 (Day 64 for Cohort 1, 2a, 2b and 3 [56-Day Interval]) | 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. |
| Number of Participants With Solicited Systemic Adverse Events (84-Day Interval) | Up 7 days post-dose 2 (Day 92 for Cohort 1 [84-Day Interval]) | 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. |
| Number of Participants With Adverse Events (Day 29) | Up to 28 days post-dose 1 (Day 29) | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. |
| Number of Participants With Adverse Events (AEs) (28-Day Interval) | Up to 28 days post-dose 2 (Day 57 for Cohorts 1, 2a, 2b and 3 [28-Day Interval]) | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. |
| Number of Participants With Adverse Events (56-day Interval) | Up 28 days post-dose 2 (Day 85 for Cohorts 1, 2a, 2b and 3 [56-Day Interval]) | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. |
| Number of Participants With Adverse Events (84-day Interval) | Up to 28 days post-dose 2 (Day 113 for Cohort 1 [84-Day Interval]) | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. |
| Number of Participants With Adverse Events Post-dose 3 (Day 393) | Up 28 days post-dose 3 (Day 393) | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. |
| Number of Participants With Serious Adverse Events | Up to 3 years and 3 months | 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. |
| Number of Participants With Immediate Reportable Events (IREs) | Up to 3 years and 3 months | 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. |
| Number of Participants With Solicited Local Adverse Events (Day 8) | 7 days post-dose 1 (Day 8) | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site. |
| Number of Participants With Solicited Local Adverse Events (28-day Interval) | Up to 7 days post-dose 2 (Day 36 for Cohort 1, 2a, 2b and 3 [28-Day Interval]) | 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 vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site. |
| Number of Participants With Solicited Local Adverse Events Post-dose 2 (56-day Interval) | Up to 7 days post-dose 2 (Day 64 for Cohort 1, 2a, 2b and 3 [56-Day Interval]) | 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 vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site. |
| Number of Participants With Solicited Local Adverse Events (84-day Interval) | Up to 7 days post-dose 2 (Day 92 for Cohort 1 [84-Day Interval]) | 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 vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site. |
| Number of Participants With Solicited Local Adverse Events (Day 372) | Up 7 days post-dose 3 (Day 372) | 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 vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site. |
| Number of Participants With Solicited Systemic Adverse Events (Day 8) | Up to 7 days post-dose 1 (Day 8) | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills. |
| Number of Participants With Solicited Systemic Adverse Events (28-Day Interval) | Up to 7 days post-dose 2 (Day 36 for Cohorts 1, 2a, 2b and 3 [28-Day Interval]) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events Post-dose 3 | Up 28 days post-dose 3 (Day 393) | 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. |
| 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 | 21-days post-dose 2 (Day 50 for Cohorts 1, 2a, 2b, 3 [28-day interval] , Day 78 for Cohort 1, 2a, 2b, 3 [56-day interval] and Day 106 Cohort 1 [84-day interval] | 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). |
Countries
Burkina Faso, Côte d’Ivoire, Kenya, Uganda
Participant flow
Pre-assignment details
A total of 1075 participants were enrolled. Among 1075 participants, 1 participant was enrolled twice and 1 participant was enrolled erroneously, but did not receive any study vaccination.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5\*10\^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365). | 225 |
| Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365). | 43 |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365). | 224 |
| Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365). | 44 |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 85. | 110 |
| Cohort 1: Placebo, Placebo, 84-Day Interval Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85. | 22 |
| Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval Participants (human immunodeficiency virus \[HIV\]-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29. | 59 |
| Cohort 2a: Placebo, Placebo, 28-Day Interval Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29. | 12 |
| Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57. | 59 |
| Cohort 2a: Placebo, Placebo, 56-Day Interval Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57. | 12 |
| Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29. | 55 |
| Cohort 2b: Placebo, Placebo, 28-Day Interval Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29. | 11 |
| Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval Participants ((Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57. | 55 |
| Cohort 2b: Placebo, Placebo, 56-Day Interval Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57. | 10 |
| Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29. | 54 |
| Cohort 3: Placebo, Placebo, 28-Day Interval Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29. | 12 |
| Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57. | 54 |
| Cohort 3: Placebo, Placebo, 56-Day Interval Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57. | 12 |
| Total | 1,073 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 2 | 1 | 4 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Other | 3 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 2 | 2 | 5 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval | Cohort 2a: Placebo, Placebo, 56-Day Interval | Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval | Cohort 2a: Placebo, Placebo, 28-Day Interval | Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval | Cohort 1: Placebo, Placebo, 84-Day Interval | Cohort 2b: Placebo, Placebo, 28-Day Interval | Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval | Cohort 2b: Placebo, Placebo, 56-Day Interval | Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval | Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval | Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval | Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | Cohort 3: Placebo, Placebo, 28-Day Interval | Cohort 3: Placebo, Placebo, 56-Day Interval | Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 7.8 years STANDARD_DEVIATION 2.23 | 42.1 years STANDARD_DEVIATION 4.96 | 32 years STANDARD_DEVIATION 10.43 | 34.3 years STANDARD_DEVIATION 7.66 | 14.4 years STANDARD_DEVIATION 1.76 | 38.8 years STANDARD_DEVIATION 6.61 | 39 years STANDARD_DEVIATION 6.69 | 33.7 years STANDARD_DEVIATION 12.31 | 14.5 years STANDARD_DEVIATION 1.86 | 14.1 years STANDARD_DEVIATION 1.56 | 14.2 years STANDARD_DEVIATION 1.81 | 33.3 years STANDARD_DEVIATION 12.41 | 31.4 years STANDARD_DEVIATION 11.53 | 33.3 years STANDARD_DEVIATION 11.57 | 7.6 years STANDARD_DEVIATION 2.06 | 7.1 years STANDARD_DEVIATION 2.07 | 7.3 years STANDARD_DEVIATION 2.09 | 33.3 years STANDARD_DEVIATION 11.52 | 28.3 years STANDARD_DEVIATION 14.07 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants | 12 Participants | 42 Participants | 12 Participants | 55 Participants | 59 Participants | 59 Participants | 21 Participants | 11 Participants | 55 Participants | 10 Participants | 222 Participants | 110 Participants | 43 Participants | 53 Participants | 12 Participants | 12 Participants | 222 Participants | 1063 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 54 Participants | 12 Participants | 42 Participants | 12 Participants | 55 Participants | 59 Participants | 59 Participants | 22 Participants | 11 Participants | 55 Participants | 10 Participants | 223 Participants | 109 Participants | 43 Participants | 54 Participants | 12 Participants | 12 Participants | 224 Participants | 1068 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Region of Enrollment BURKINA FASO | 23 Participants | 2 Participants | 16 Participants | 4 Participants | 26 Participants | 16 Participants | 14 Participants | 1 Participants | 5 Participants | 29 Participants | 4 Participants | 76 Participants | 30 Participants | 16 Participants | 25 Participants | 5 Participants | 4 Participants | 73 Participants | 369 Participants |
| Region of Enrollment COTE D'IVOIRE | 12 Participants | 2 Participants | 9 Participants | 1 Participants | 0 Participants | 8 Participants | 11 Participants | 7 Participants | 0 Participants | 0 Participants | 0 Participants | 38 Participants | 22 Participants | 6 Participants | 12 Participants | 3 Participants | 3 Participants | 44 Participants | 178 Participants |
| Region of Enrollment KENYA | 5 Participants | 3 Participants | 3 Participants | 4 Participants | 12 Participants | 14 Participants | 12 Participants | 4 Participants | 3 Participants | 13 Participants | 2 Participants | 28 Participants | 16 Participants | 5 Participants | 5 Participants | 1 Participants | 1 Participants | 27 Participants | 158 Participants |
| Region of Enrollment UGANDA | 14 Participants | 5 Participants | 15 Participants | 3 Participants | 17 Participants | 21 Participants | 22 Participants | 10 Participants | 3 Participants | 13 Participants | 4 Participants | 83 Participants | 42 Participants | 17 Participants | 12 Participants | 3 Participants | 4 Participants | 80 Participants | 368 Participants |
| Sex: Female, Male Female | 28 Participants | 10 Participants | 15 Participants | 8 Participants | 25 Participants | 39 Participants | 42 Participants | 8 Participants | 5 Participants | 26 Participants | 4 Participants | 73 Participants | 27 Participants | 16 Participants | 27 Participants | 5 Participants | 5 Participants | 71 Participants | 434 Participants |
| Sex: Female, Male Male | 26 Participants | 2 Participants | 28 Participants | 4 Participants | 30 Participants | 20 Participants | 17 Participants | 14 Participants | 6 Participants | 29 Participants | 6 Participants | 152 Participants | 83 Participants | 28 Participants | 27 Participants | 7 Participants | 7 Participants | 153 Participants | 639 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 225 | 0 / 43 | 0 / 224 | 0 / 44 | 0 / 110 | 0 / 22 | 1 / 59 | 0 / 12 | 0 / 59 | 0 / 12 | 1 / 55 | 0 / 11 | 0 / 55 | 0 / 10 | 0 / 54 | 0 / 12 | 0 / 54 | 0 / 12 |
| other Total, other adverse events | 94 / 225 | 17 / 43 | 80 / 224 | 21 / 44 | 43 / 110 | 12 / 22 | 24 / 59 | 9 / 12 | 28 / 59 | 5 / 12 | 29 / 55 | 5 / 11 | 33 / 55 | 6 / 10 | 27 / 54 | 9 / 12 | 22 / 54 | 9 / 12 |
| serious Total, serious adverse events | 7 / 225 | 1 / 43 | 7 / 224 | 0 / 44 | 6 / 110 | 0 / 22 | 1 / 59 | 0 / 12 | 1 / 59 | 0 / 12 | 1 / 55 | 0 / 11 | 0 / 55 | 0 / 10 | 1 / 54 | 0 / 12 | 0 / 54 | 1 / 12 |
Outcome results
Primary
Number of Participants With Adverse Events (56-day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Time frame: Up 28 days post-dose 2 (Day 85 for Cohorts 1, 2a, 2b and 3 [56-Day Interval])
Population: 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). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval | Number of Participants With Adverse Events (56-day Interval) | 58 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval | Number of Participants With Adverse Events (56-day Interval) | 13 Participants |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval | Number of Participants With Adverse Events (56-day Interval) | 22 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval | Number of Participants With Adverse Events (56-day Interval) | 4 Participants |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval | Number of Participants With Adverse Events (56-day Interval) | 26 Participants |
| Cohort 1: Placebo, Placebo, 84-Day Interval | Number of Participants With Adverse Events (56-day Interval) | 4 Participants |
| Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | Number of Participants With Adverse Events (56-day Interval) | 22 Participants |
| Cohort 2a: Placebo, Placebo, 28-Day Interval | Number of Participants With Adverse Events (56-day Interval) | 8 Participants |
Primary
Number of Participants With Adverse Events (84-day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Time frame: Up to 28 days post-dose 2 (Day 113 for Cohort 1 [84-Day Interval])
Population: 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). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval | Number of Participants With Adverse Events (84-day Interval) | 34 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval | Number of Participants With Adverse Events (84-day Interval) | 7 Participants |
Primary
Number of Participants With Adverse Events (AEs) (28-Day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Time frame: Up to 28 days post-dose 2 (Day 57 for Cohorts 1, 2a, 2b and 3 [28-Day Interval])
Population: 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). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval | Number of Participants With Adverse Events (AEs) (28-Day Interval) | 74 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval | Number of Participants With Adverse Events (AEs) (28-Day Interval) | 15 Participants |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval | Number of Participants With Adverse Events (AEs) (28-Day Interval) | 22 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval | Number of Participants With Adverse Events (AEs) (28-Day Interval) | 4 Participants |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval | Number of Participants With Adverse Events (AEs) (28-Day Interval) | 18 Participants |
| Cohort 1: Placebo, Placebo, 84-Day Interval | Number of Participants With Adverse Events (AEs) (28-Day Interval) | 4 Participants |
| Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | Number of Participants With Adverse Events (AEs) (28-Day Interval) | 20 Participants |
| Cohort 2a: Placebo, Placebo, 28-Day Interval | Number of Participants With Adverse Events (AEs) (28-Day Interval) | 7 Participants |
Primary
Number of Participants With Adverse Events (Day 29)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Time frame: Up to 28 days post-dose 1 (Day 29)
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval | Number of Participants With Adverse Events (Day 29) | 96 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval | Number of Participants With Adverse Events (Day 29) | 17 Participants |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval | Number of Participants With Adverse Events (Day 29) | 68 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval | Number of Participants With Adverse Events (Day 29) | 17 Participants |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval | Number of Participants With Adverse Events (Day 29) | 37 Participants |
| Cohort 1: Placebo, Placebo, 84-Day Interval | Number of Participants With Adverse Events (Day 29) | 6 Participants |
| Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | Number of Participants With Adverse Events (Day 29) | 25 Participants |
| Cohort 2a: Placebo, Placebo, 28-Day Interval | Number of Participants With Adverse Events (Day 29) | 7 Participants |
| Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval | Number of Participants With Adverse Events (Day 29) | 25 Participants |
| Cohort 2a: Placebo, Placebo, 56-Day Interval | Number of Participants With Adverse Events (Day 29) | 3 Participants |
| Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | Number of Participants With Adverse Events (Day 29) | 28 Participants |
| Cohort 2b: Placebo, Placebo, 28-Day Interval | Number of Participants With Adverse Events (Day 29) | 4 Participants |
| Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval | Number of Participants With Adverse Events (Day 29) | 31 Participants |
| Cohort 2b: Placebo, Placebo, 56-Day Interval | Number of Participants With Adverse Events (Day 29) | 5 Participants |
| Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | Number of Participants With Adverse Events (Day 29) | 23 Participants |
| Cohort 3: Placebo, Placebo, 28-Day Interval | Number of Participants With Adverse Events (Day 29) | 4 Participants |
| Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval | Number of Participants With Adverse Events (Day 29) | 19 Participants |
| Cohort 3: Placebo, Placebo, 56-Day Interval | Number of Participants With Adverse Events (Day 29) | 4 Participants |
Primary
Number of Participants With Adverse Events Post-dose 3 (Day 393)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Time frame: Up 28 days post-dose 3 (Day 393)
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval | Number of Participants With Adverse Events Post-dose 3 (Day 393) | 9 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval | Number of Participants With Adverse Events Post-dose 3 (Day 393) | 3 Participants |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval | Number of Participants With Adverse Events Post-dose 3 (Day 393) | 14 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval | Number of Participants With Adverse Events Post-dose 3 (Day 393) | 0 Participants |
Primary
Number of Participants With Immediate Reportable Events (IREs)
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.
Time frame: Up to 3 years and 3 months
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval | Number of Participants With Immediate Reportable Events (IREs) | 0 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval | Number of Participants With Immediate Reportable Events (IREs) | 0 Participants |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval | Number of Participants With Immediate Reportable Events (IREs) | 0 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval | Number of Participants With Immediate Reportable Events (IREs) | 0 Participants |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval | Number of Participants With Immediate Reportable Events (IREs) | 0 Participants |
| Cohort 1: Placebo, Placebo, 84-Day Interval | Number of Participants With Immediate Reportable Events (IREs) | 0 Participants |
| Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | Number of Participants With Immediate Reportable Events (IREs) | 0 Participants |
| Cohort 2a: Placebo, Placebo, 28-Day Interval | Number of Participants With Immediate Reportable Events (IREs) | 0 Participants |
| Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval | Number of Participants With Immediate Reportable Events (IREs) | 0 Participants |
| Cohort 2a: Placebo, Placebo, 56-Day Interval | Number of Participants With Immediate Reportable Events (IREs) | 0 Participants |
| Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | Number of Participants With Immediate Reportable Events (IREs) | 0 Participants |
| Cohort 2b: Placebo, Placebo, 28-Day Interval | Number of Participants With Immediate Reportable Events (IREs) | 0 Participants |
| Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval | Number of Participants With Immediate Reportable Events (IREs) | 0 Participants |
| Cohort 2b: Placebo, Placebo, 56-Day Interval | Number of Participants With Immediate Reportable Events (IREs) | 0 Participants |
| Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | Number of Participants With Immediate Reportable Events (IREs) | 0 Participants |
| Cohort 3: Placebo, Placebo, 28-Day Interval | Number of Participants With Immediate Reportable Events (IREs) | 0 Participants |
| Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval | Number of Participants With Immediate Reportable Events (IREs) | 0 Participants |
| Cohort 3: Placebo, Placebo, 56-Day Interval | Number of Participants With Immediate Reportable Events (IREs) | 0 Participants |
Primary
Number of Participants With Serious Adverse Events
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.
Time frame: Up to 3 years and 3 months
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval | Number of Participants With Serious Adverse Events | 7 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval | Number of Participants With Serious Adverse Events | 1 Participants |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval | Number of Participants With Serious Adverse Events | 7 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval | Number of Participants With Serious Adverse Events | 0 Participants |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval | Number of Participants With Serious Adverse Events | 6 Participants |
| Cohort 1: Placebo, Placebo, 84-Day Interval | Number of Participants With Serious Adverse Events | 0 Participants |
| Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | Number of Participants With Serious Adverse Events | 1 Participants |
| Cohort 2a: Placebo, Placebo, 28-Day Interval | Number of Participants With Serious Adverse Events | 0 Participants |
| Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval | Number of Participants With Serious Adverse Events | 1 Participants |
| Cohort 2a: Placebo, Placebo, 56-Day Interval | Number of Participants With Serious Adverse Events | 0 Participants |
| Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | Number of Participants With Serious Adverse Events | 1 Participants |
| Cohort 2b: Placebo, Placebo, 28-Day Interval | Number of Participants With Serious Adverse Events | 0 Participants |
| Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval | Number of Participants With Serious Adverse Events | 0 Participants |
| Cohort 2b: Placebo, Placebo, 56-Day Interval | Number of Participants With Serious Adverse Events | 0 Participants |
| Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | Number of Participants With Serious Adverse Events | 1 Participants |
| Cohort 3: Placebo, Placebo, 28-Day Interval | Number of Participants With Serious Adverse Events | 0 Participants |
| Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval | Number of Participants With Serious Adverse Events | 0 Participants |
| Cohort 3: Placebo, Placebo, 56-Day Interval | Number of Participants With Serious Adverse Events | 1 Participants |
Primary
Number of Participants With Solicited Local Adverse Events (28-day Interval)
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 vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Time frame: Up to 7 days post-dose 2 (Day 36 for Cohort 1, 2a, 2b and 3 [28-Day Interval])
Population: 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). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval | Number of Participants With Solicited Local Adverse Events (28-day Interval) | 126 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval | Number of Participants With Solicited Local Adverse Events (28-day Interval) | 9 Participants |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval | Number of Participants With Solicited Local Adverse Events (28-day Interval) | 26 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval | Number of Participants With Solicited Local Adverse Events (28-day Interval) | 2 Participants |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval | Number of Participants With Solicited Local Adverse Events (28-day Interval) | 29 Participants |
| Cohort 1: Placebo, Placebo, 84-Day Interval | Number of Participants With Solicited Local Adverse Events (28-day Interval) | 3 Participants |
| Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | Number of Participants With Solicited Local Adverse Events (28-day Interval) | 22 Participants |
| Cohort 2a: Placebo, Placebo, 28-Day Interval | Number of Participants With Solicited Local Adverse Events (28-day Interval) | 2 Participants |
Primary
Number of Participants With Solicited Local Adverse Events (84-day Interval)
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 vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Time frame: Up to 7 days post-dose 2 (Day 92 for Cohort 1 [84-Day Interval])
Population: 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). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval | Number of Participants With Solicited Local Adverse Events (84-day Interval) | 57 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval | Number of Participants With Solicited Local Adverse Events (84-day Interval) | 9 Participants |
Primary
Number of Participants With Solicited Local Adverse Events (Day 372)
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 vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Time frame: Up 7 days post-dose 3 (Day 372)
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval | Number of Participants With Solicited Local Adverse Events (Day 372) | 18 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval | Number of Participants With Solicited Local Adverse Events (Day 372) | 1 Participants |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval | Number of Participants With Solicited Local Adverse Events (Day 372) | 16 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval | Number of Participants With Solicited Local Adverse Events (Day 372) | 3 Participants |
Primary
Number of Participants With Solicited Local Adverse Events (Day 8)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Time frame: 7 days post-dose 1 (Day 8)
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval | Number of Participants With Solicited Local Adverse Events (Day 8) | 123 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval | Number of Participants With Solicited Local Adverse Events (Day 8) | 16 Participants |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval | Number of Participants With Solicited Local Adverse Events (Day 8) | 121 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval | Number of Participants With Solicited Local Adverse Events (Day 8) | 20 Participants |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval | Number of Participants With Solicited Local Adverse Events (Day 8) | 63 Participants |
| Cohort 1: Placebo, Placebo, 84-Day Interval | Number of Participants With Solicited Local Adverse Events (Day 8) | 11 Participants |
| Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | Number of Participants With Solicited Local Adverse Events (Day 8) | 34 Participants |
| Cohort 2a: Placebo, Placebo, 28-Day Interval | Number of Participants With Solicited Local Adverse Events (Day 8) | 4 Participants |
| Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval | Number of Participants With Solicited Local Adverse Events (Day 8) | 35 Participants |
| Cohort 2a: Placebo, Placebo, 56-Day Interval | Number of Participants With Solicited Local Adverse Events (Day 8) | 2 Participants |
| Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | Number of Participants With Solicited Local Adverse Events (Day 8) | 26 Participants |
| Cohort 2b: Placebo, Placebo, 28-Day Interval | Number of Participants With Solicited Local Adverse Events (Day 8) | 3 Participants |
| Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval | Number of Participants With Solicited Local Adverse Events (Day 8) | 30 Participants |
| Cohort 2b: Placebo, Placebo, 56-Day Interval | Number of Participants With Solicited Local Adverse Events (Day 8) | 5 Participants |
| Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | Number of Participants With Solicited Local Adverse Events (Day 8) | 26 Participants |
| Cohort 3: Placebo, Placebo, 28-Day Interval | Number of Participants With Solicited Local Adverse Events (Day 8) | 6 Participants |
| Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval | Number of Participants With Solicited Local Adverse Events (Day 8) | 29 Participants |
| Cohort 3: Placebo, Placebo, 56-Day Interval | Number of Participants With Solicited Local Adverse Events (Day 8) | 5 Participants |
Primary
Number of Participants With Solicited Local Adverse Events Post-dose 2 (56-day Interval)
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 vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Time frame: Up to 7 days post-dose 2 (Day 64 for Cohort 1, 2a, 2b and 3 [56-Day Interval])
Population: 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). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval | Number of Participants With Solicited Local Adverse Events Post-dose 2 (56-day Interval) | 113 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval | Number of Participants With Solicited Local Adverse Events Post-dose 2 (56-day Interval) | 16 Participants |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval | Number of Participants With Solicited Local Adverse Events Post-dose 2 (56-day Interval) | 25 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval | Number of Participants With Solicited Local Adverse Events Post-dose 2 (56-day Interval) | 2 Participants |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval | Number of Participants With Solicited Local Adverse Events Post-dose 2 (56-day Interval) | 20 Participants |
| Cohort 1: Placebo, Placebo, 84-Day Interval | Number of Participants With Solicited Local Adverse Events Post-dose 2 (56-day Interval) | 3 Participants |
| Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | Number of Participants With Solicited Local Adverse Events Post-dose 2 (56-day Interval) | 22 Participants |
| Cohort 2a: Placebo, Placebo, 28-Day Interval | Number of Participants With Solicited Local Adverse Events Post-dose 2 (56-day Interval) | 2 Participants |
Primary
Number of Participants With Solicited Systemic Adverse Events (28-Day Interval)
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.
Time frame: Up to 7 days post-dose 2 (Day 36 for Cohorts 1, 2a, 2b and 3 [28-Day Interval])
Population: 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). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval | Number of Participants With Solicited Systemic Adverse Events (28-Day Interval) | 121 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval | Number of Participants With Solicited Systemic Adverse Events (28-Day Interval) | 14 Participants |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval | Number of Participants With Solicited Systemic Adverse Events (28-Day Interval) | 32 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval | Number of Participants With Solicited Systemic Adverse Events (28-Day Interval) | 4 Participants |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval | Number of Participants With Solicited Systemic Adverse Events (28-Day Interval) | 27 Participants |
| Cohort 1: Placebo, Placebo, 84-Day Interval | Number of Participants With Solicited Systemic Adverse Events (28-Day Interval) | 3 Participants |
| Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | Number of Participants With Solicited Systemic Adverse Events (28-Day Interval) | 10 Participants |
| Cohort 2a: Placebo, Placebo, 28-Day Interval | Number of Participants With Solicited Systemic Adverse Events (28-Day Interval) | 3 Participants |
Primary
Number of Participants With Solicited Systemic Adverse Events (56-Day Interval)
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.
Time frame: Up 7 days post-dose 2 (Day 64 for Cohort 1, 2a, 2b and 3 [56-Day Interval])
Population: 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). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval | Number of Participants With Solicited Systemic Adverse Events (56-Day Interval) | 121 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval | Number of Participants With Solicited Systemic Adverse Events (56-Day Interval) | 21 Participants |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval | Number of Participants With Solicited Systemic Adverse Events (56-Day Interval) | 26 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval | Number of Participants With Solicited Systemic Adverse Events (56-Day Interval) | 6 Participants |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval | Number of Participants With Solicited Systemic Adverse Events (56-Day Interval) | 25 Participants |
| Cohort 1: Placebo, Placebo, 84-Day Interval | Number of Participants With Solicited Systemic Adverse Events (56-Day Interval) | 6 Participants |
| Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | Number of Participants With Solicited Systemic Adverse Events (56-Day Interval) | 10 Participants |
| Cohort 2a: Placebo, Placebo, 28-Day Interval | Number of Participants With Solicited Systemic Adverse Events (56-Day Interval) | 4 Participants |
Primary
Number of Participants With Solicited Systemic Adverse Events (84-Day Interval)
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.
Time frame: Up 7 days post-dose 2 (Day 92 for Cohort 1 [84-Day Interval])
Population: 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). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval | Number of Participants With Solicited Systemic Adverse Events (84-Day Interval) | 64 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval | Number of Participants With Solicited Systemic Adverse Events (84-Day Interval) | 14 Participants |
Primary
Number of Participants With Solicited Systemic Adverse Events (Day 372)
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.
Time frame: Up to 7 days post-dose 3 (Day 372)
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval | Number of Participants With Solicited Systemic Adverse Events (Day 372) | 17 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval | Number of Participants With Solicited Systemic Adverse Events (Day 372) | 2 Participants |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval | Number of Participants With Solicited Systemic Adverse Events (Day 372) | 18 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval | Number of Participants With Solicited Systemic Adverse Events (Day 372) | 4 Participants |
Primary
Number of Participants With Solicited Systemic Adverse Events (Day 8)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Time frame: Up to 7 days post-dose 1 (Day 8)
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval | Number of Participants With Solicited Systemic Adverse Events (Day 8) | 146 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval | Number of Participants With Solicited Systemic Adverse Events (Day 8) | 27 Participants |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval | Number of Participants With Solicited Systemic Adverse Events (Day 8) | 140 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval | Number of Participants With Solicited Systemic Adverse Events (Day 8) | 26 Participants |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval | Number of Participants With Solicited Systemic Adverse Events (Day 8) | 75 Participants |
| Cohort 1: Placebo, Placebo, 84-Day Interval | Number of Participants With Solicited Systemic Adverse Events (Day 8) | 14 Participants |
| Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | Number of Participants With Solicited Systemic Adverse Events (Day 8) | 44 Participants |
| Cohort 2a: Placebo, Placebo, 28-Day Interval | Number of Participants With Solicited Systemic Adverse Events (Day 8) | 7 Participants |
| Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval | Number of Participants With Solicited Systemic Adverse Events (Day 8) | 36 Participants |
| Cohort 2a: Placebo, Placebo, 56-Day Interval | Number of Participants With Solicited Systemic Adverse Events (Day 8) | 2 Participants |
| Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | Number of Participants With Solicited Systemic Adverse Events (Day 8) | 29 Participants |
| Cohort 2b: Placebo, Placebo, 28-Day Interval | Number of Participants With Solicited Systemic Adverse Events (Day 8) | 4 Participants |
| Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval | Number of Participants With Solicited Systemic Adverse Events (Day 8) | 30 Participants |
| Cohort 2b: Placebo, Placebo, 56-Day Interval | Number of Participants With Solicited Systemic Adverse Events (Day 8) | 5 Participants |
| Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | Number of Participants With Solicited Systemic Adverse Events (Day 8) | 24 Participants |
| Cohort 3: Placebo, Placebo, 28-Day Interval | Number of Participants With Solicited Systemic Adverse Events (Day 8) | 2 Participants |
| Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval | Number of Participants With Solicited Systemic Adverse Events (Day 8) | 23 Participants |
| Cohort 3: Placebo, Placebo, 56-Day Interval | Number of Participants With Solicited Systemic Adverse Events (Day 8) | 2 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
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).
Time frame: 21-days post-dose 2 (Day 50 for Cohorts 1, 2a, 2b, 3 [28-day interval] , Day 78 for Cohort 1, 2a, 2b, 3 [56-day interval] and Day 106 Cohort 1 [84-day interval]
Population: The per protocol analysis set included all randomized and vaccinated participants, who received both the prime and boost vaccinations (administered not more than 10 days outside the visit window), have immunogenicity data, from baseline and at least one post-vaccination evaluable immunogenicity sample, and have no major protocol violations influencing the immune response.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval | 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 | Day 50 (21 days post-dose 2) | 3085 ELISA units/mL |
| Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval | 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 | Day 50 (21 days post-dose 2) | NA ELISA units/mL |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval | 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 | Day 78 (21 days post-dose 2) | 7518 ELISA units/mL |
| Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval | 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 | Day 78 (21 days post-dose 2) | NA ELISA units/mL |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval | 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 | Day 106 (21 days post-dose 2) | 7300 ELISA units/mL |
| Cohort 1: Placebo, Placebo, 84-Day Interval | 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 | Day 106 (21 days post-dose 2) | NA ELISA units/mL |
| Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | 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 | Day 50 (21 days post-dose 2) | 4207 ELISA units/mL |
| Cohort 2a: Placebo, Placebo, 28-Day Interval | 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 | Day 50 (21 days post-dose 2) | NA ELISA units/mL |
| Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval | 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 | Day 78 (21 days post-dose 2) | 5283 ELISA units/mL |
| Cohort 2a: Placebo, Placebo, 56-Day Interval | 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 | Day 78 (21 days post-dose 2) | NA ELISA units/mL |
| Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | 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 | Day 50 (21 days post-dose 2) | 6993 ELISA units/mL |
| Cohort 2b: Placebo, Placebo, 28-Day Interval | 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 | Day 50 (21 days post-dose 2) | NA ELISA units/mL |
| Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval | 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 | Day 78 (21 days post-dose 2) | 13532 ELISA units/mL |
| Cohort 2b: Placebo, Placebo, 56-Day Interval | 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 | Day 78 (21 days post-dose 2) | 37 ELISA units/mL |
| Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval | 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 | Day 50 (21 days post-dose 2) | 8007 ELISA units/mL |
| Cohort 3: Placebo, Placebo, 28-Day Interval | 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 | Day 50 (21 days post-dose 2) | NA ELISA units/mL |
| Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval | 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 | Day 78 (21 days post-dose 2) | 17388 ELISA units/mL |
| Cohort 3: Placebo, Placebo, 56-Day Interval | 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 | Day 78 (21 days post-dose 2) | NA ELISA units/mL |
Secondary
Number of Participants With Serious Adverse Events Post-dose 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.
Time frame: Up 28 days post-dose 3 (Day 393)
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval | Number of Participants With Serious Adverse Events Post-dose 3 | 0 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval | Number of Participants With Serious Adverse Events Post-dose 3 | 0 Participants |
| Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval | Number of Participants With Serious Adverse Events Post-dose 3 | 0 Participants |
| Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval | Number of Participants With Serious Adverse Events Post-dose 3 | 0 Participants |