Hemorrhagic Fever, Ebola
Conditions
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
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.
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 percent (%) saline.
Sponsors
Walter Reed Army Institute of Research (WRAIR)
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
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 2 (Group 1): GMCs of Binding Antibody Levels Against EBOV GP Measured Using FANG ELISA | 21-days post dose 2 (Day 50) | 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. |
| Parts 1 and 2: Number of Participants With Solicited Systemic Adverse Events 7 Days Post First Vaccination | 7 days post dose 1 (up to Day 8) | 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. |
| Part 1, Part 2 (Group 2): Number of Participants With Unsolicited Adverse Events | Up to 28 days post each dose (up to Day 43) | 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. |
| Part 2 (Group 1): Number of Participants With Unsolicited Adverse Events | Up to 28 days post dose 2 visit (up to Day 57) | 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. |
| Part 1, Part 2 (Group 2): Number of Participants With Serious Adverse Events (SAEs) | Up to 1 year post dose 2 (up to Day 380) | 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. |
| Part 2 (Group 1): Number of Participants With SAEs | Up to 1 year post dose 2 (up to Day 394) | 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. |
| Part 1, Part 2 (Group 2): Number of Participants With Immediate Reportable Events (IREs) | Up to 1 year post dose 2 (up to Day 380) | 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. |
| Part 2 (Group 1): Number of Participants With IREs | Up to 1 year post dose 2 (up to Day 394) | 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. |
| Parts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) 7 Days Post First Vaccination | 7 days post dose 1 (up to Day 8) | 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. |
| Part 1, Part 2 (Group 2): Number of Participants With Solicited Local AEs 7 Days Post Second Vaccination | 7 days post dose 2 (up to Day 22) | 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. |
| Part 2 (Group 1): Number of Participants With Solicited Local AEs 7 Days Post Second Vaccination | 7 days post dose 2 (up to Day 36) | 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. |
| Part 1, Part 2 (Group 2): Number of Participants With Solicited Systemic AEs 7 Days Post Second Vaccination | 7 days post dose 2 (up to Day 22) | 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. |
| Part 2 (Group 1): Number of Participants With Solicited Systemic AEs 7 Days Post Second Vaccination | 7 days post dose 2 (up to Day 36) | 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. |
| 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) | 21-days post dose 2 (up to Day 36) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 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) | 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. |
Countries
Kenya, Mozambique, Nigeria, Tanzania, Uganda, United States
Participant flow
Pre-assignment details
Out of 578 randomized participants, 574 received at least one dose of study vaccine.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| 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. | 10 |
| 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. | 20 |
| 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. | 5 |
| 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. | 161 |
| 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. | 39 |
| 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. | 161 |
| 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. | 39 |
| 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. | 39 |
| 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. | 10 |
| 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. | 40 |
| 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. | 10 |
| Total | 574 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 1 | 0 | 5 | 1 | 2 | 1 | 0 | 0 | 1 | 0 |
| Overall Study | Other | 0 | 0 | 1 | 0 | 3 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 2 | 0 | 2 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Part 1: MVA-BN-Filo and Ad26.ZEBOV (Healthy Participants) | Part 1: Placebo (Healthy Participants) | Part 1: MVA-BN-Filo and Ad26.ZEBOV (HIV-infected Participants) | Part 1: Placebo (HIV-infected Participants) | Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants) | Part 2 (Group 1): Placebo (Healthy Participants) | Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants) | Part 2 (Group 1): Placebo (HIV-infected Participants) | Part 2 (Group 2): MVA-BN-Filo and Ad26.ZEBOV (Healthy Participants) | Part 2 (Group 2): Placebo (Healthy Participants) | Part 2 (Group 2): MVA-BN-Filo and Ad26.ZEBOV (HIV-infected Participants) | Part 2 (Group 2): Placebo (HIV-infected Participants) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 42 years STANDARD_DEVIATION 14.42 | 47.3 years STANDARD_DEVIATION 11.84 | 46.7 years STANDARD_DEVIATION 12.89 | 46 years STANDARD_DEVIATION 8.63 | 29.1 years STANDARD_DEVIATION 7.56 | 28.4 years STANDARD_DEVIATION 7.37 | 37.5 years STANDARD_DEVIATION 9.78 | 38.9 years STANDARD_DEVIATION 8.74 | 28 years STANDARD_DEVIATION 7.72 | 26.9 years STANDARD_DEVIATION 12.56 | 38.5 years STANDARD_DEVIATION 9.91 | 41 years STANDARD_DEVIATION 9.78 | 34.8 years STANDARD_DEVIATION 11.02 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 2 Participants | 0 Participants | 7 Participants | 1 Participants | 3 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 10 Participants | 18 Participants | 5 Participants | 154 Participants | 38 Participants | 158 Participants | 37 Participants | 38 Participants | 9 Participants | 40 Participants | 10 Participants | 554 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 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 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) Black or African American | 19 Participants | 6 Participants | 13 Participants | 4 Participants | 160 Participants | 39 Participants | 159 Participants | 39 Participants | 39 Participants | 10 Participants | 40 Participants | 10 Participants | 538 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 |
| 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 |
| 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 |
| Race (NIH/OMB) White | 21 Participants | 4 Participants | 5 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 34 Participants |
| Region of Enrollment KENYA | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 50 Participants | 9 Participants | 79 Participants | 21 Participants | 10 Participants | 6 Participants | 15 Participants | 7 Participants | 197 Participants |
| Region of Enrollment MOZAMBIQUE | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 32 Participants | 7 Participants | 23 Participants | 5 Participants | 8 Participants | 3 Participants | 5 Participants | 0 Participants | 83 Participants |
| Region of Enrollment NIGERIA | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 17 Participants | 3 Participants | 11 Participants | 1 Participants | 2 Participants | 0 Participants | 3 Participants | 1 Participants | 38 Participants |
| Region of Enrollment TANZANIA, UNITED REPUBLIC OF | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 31 Participants | 9 Participants | 14 Participants | 4 Participants | 11 Participants | 1 Participants | 4 Participants | 1 Participants | 75 Participants |
| Region of Enrollment UGANDA | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 31 Participants | 11 Participants | 34 Participants | 8 Participants | 8 Participants | 0 Participants | 13 Participants | 1 Participants | 106 Participants |
| Region of Enrollment UNITED STATES | 40 Participants | 10 Participants | 20 Participants | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 75 Participants |
| Sex: Female, Male Female | 18 Participants | 7 Participants | 2 Participants | 1 Participants | 69 Participants | 19 Participants | 95 Participants | 22 Participants | 20 Participants | 6 Participants | 26 Participants | 4 Participants | 289 Participants |
| Sex: Female, Male Male | 22 Participants | 3 Participants | 18 Participants | 4 Participants | 92 Participants | 20 Participants | 66 Participants | 17 Participants | 19 Participants | 4 Participants | 14 Participants | 6 Participants | 285 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 10 | 0 / 20 | 0 / 5 | 0 / 39 | 0 / 10 | 0 / 40 | 0 / 10 | 0 / 161 | 0 / 39 | 0 / 161 | 0 / 39 |
| other Total, other adverse events | 11 / 40 | 5 / 10 | 11 / 20 | 0 / 5 | 12 / 39 | 5 / 10 | 13 / 40 | 3 / 10 | 53 / 161 | 15 / 39 | 51 / 161 | 11 / 39 |
| serious Total, serious adverse events | 1 / 40 | 1 / 10 | 1 / 20 | 1 / 5 | 0 / 39 | 0 / 10 | 2 / 40 | 0 / 10 | 1 / 161 | 1 / 39 | 2 / 161 | 0 / 39 |
Outcome results
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.
Time frame: 21-days post dose 2 (up to Day 36)
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | 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) | 5733 EU/mL |
| Healthy (Part 1, Part 2; Group 2): Placebo | 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) | 40 EU/mL |
| HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | 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) | 2325 EU/mL |
| HIV-infected (Part 1, Part 2; Group 2): Placebo | 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) | NA EU/mL |
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.
Time frame: Up to 1 year post dose 2 (up to Day 380)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Part 1, Part 2 (Group 2): Number of Participants With Immediate Reportable Events (IREs) | 0 Participants |
| Healthy (Part 1, Part 2; Group 2): Placebo | Part 1, Part 2 (Group 2): Number of Participants With Immediate Reportable Events (IREs) | 0 Participants |
| HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Part 1, Part 2 (Group 2): Number of Participants With Immediate Reportable Events (IREs) | 0 Participants |
| HIV-infected (Part 1, Part 2; Group 2): Placebo | Part 1, Part 2 (Group 2): Number of Participants With Immediate Reportable Events (IREs) | 0 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.
Time frame: Up to 1 year post dose 2 (up to Day 380)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Part 1, Part 2 (Group 2): Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Healthy (Part 1, Part 2; Group 2): Placebo | Part 1, Part 2 (Group 2): Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Part 1, Part 2 (Group 2): Number of Participants With Serious Adverse Events (SAEs) | 3 Participants |
| HIV-infected (Part 1, Part 2; Group 2): Placebo | Part 1, Part 2 (Group 2): Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
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.
Time frame: 7 days post dose 2 (up to Day 22)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Part 1, Part 2 (Group 2): Number of Participants With Solicited Local AEs 7 Days Post Second Vaccination | 44 Participants |
| Healthy (Part 1, Part 2; Group 2): Placebo | Part 1, Part 2 (Group 2): Number of Participants With Solicited Local AEs 7 Days Post Second Vaccination | 4 Participants |
| HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Part 1, Part 2 (Group 2): Number of Participants With Solicited Local AEs 7 Days Post Second Vaccination | 33 Participants |
| HIV-infected (Part 1, Part 2; Group 2): Placebo | Part 1, Part 2 (Group 2): Number of Participants With Solicited Local AEs 7 Days Post Second Vaccination | 0 Participants |
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.
Time frame: 7 days post dose 2 (up to Day 22)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Part 1, Part 2 (Group 2): Number of Participants With Solicited Systemic AEs 7 Days Post Second Vaccination | 45 Participants |
| Healthy (Part 1, Part 2; Group 2): Placebo | Part 1, Part 2 (Group 2): Number of Participants With Solicited Systemic AEs 7 Days Post Second Vaccination | 8 Participants |
| HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Part 1, Part 2 (Group 2): Number of Participants With Solicited Systemic AEs 7 Days Post Second Vaccination | 35 Participants |
| HIV-infected (Part 1, Part 2; Group 2): Placebo | Part 1, Part 2 (Group 2): Number of Participants With Solicited Systemic AEs 7 Days Post Second Vaccination | 4 Participants |
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.
Time frame: Up to 28 days post each dose (up to Day 43)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Part 1, Part 2 (Group 2): Number of Participants With Unsolicited Adverse Events | 33 Participants |
| Healthy (Part 1, Part 2; Group 2): Placebo | Part 1, Part 2 (Group 2): Number of Participants With Unsolicited Adverse Events | 10 Participants |
| HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Part 1, Part 2 (Group 2): Number of Participants With Unsolicited Adverse Events | 32 Participants |
| HIV-infected (Part 1, Part 2; Group 2): Placebo | Part 1, Part 2 (Group 2): Number of Participants With Unsolicited Adverse Events | 3 Participants |
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.
Time frame: 21-days post dose 2 (Day 50)
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Part 2 (Group 1): GMCs of Binding Antibody Levels Against EBOV GP Measured Using FANG ELISA | 6037 EU/mL |
| Healthy (Part 1, Part 2; Group 2): Placebo | Part 2 (Group 1): GMCs of Binding Antibody Levels Against EBOV GP Measured Using FANG ELISA | NA EU/mL |
| HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Part 2 (Group 1): GMCs of Binding Antibody Levels Against EBOV GP Measured Using FANG ELISA | 2939 EU/mL |
| HIV-infected (Part 1, Part 2; Group 2): Placebo | Part 2 (Group 1): GMCs of Binding Antibody Levels Against EBOV GP Measured Using FANG ELISA | NA EU/mL |
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.
Time frame: Up to 1 year post dose 2 (up to Day 394)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Part 2 (Group 1): Number of Participants With IREs | 0 Participants |
| Healthy (Part 1, Part 2; Group 2): Placebo | Part 2 (Group 1): Number of Participants With IREs | 0 Participants |
| HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Part 2 (Group 1): Number of Participants With IREs | 0 Participants |
| HIV-infected (Part 1, Part 2; Group 2): Placebo | Part 2 (Group 1): Number of Participants With IREs | 0 Participants |
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.
Time frame: Up to 1 year post dose 2 (up to Day 394)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Part 2 (Group 1): Number of Participants With SAEs | 1 Participants |
| Healthy (Part 1, Part 2; Group 2): Placebo | Part 2 (Group 1): Number of Participants With SAEs | 1 Participants |
| HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Part 2 (Group 1): Number of Participants With SAEs | 2 Participants |
| HIV-infected (Part 1, Part 2; Group 2): Placebo | Part 2 (Group 1): Number of Participants With SAEs | 0 Participants |
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.
Time frame: 7 days post dose 2 (up to Day 36)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Part 2 (Group 1): Number of Participants With Solicited Local AEs 7 Days Post Second Vaccination | 82 Participants |
| Healthy (Part 1, Part 2; Group 2): Placebo | Part 2 (Group 1): Number of Participants With Solicited Local AEs 7 Days Post Second Vaccination | 7 Participants |
| HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Part 2 (Group 1): Number of Participants With Solicited Local AEs 7 Days Post Second Vaccination | 64 Participants |
| HIV-infected (Part 1, Part 2; Group 2): Placebo | Part 2 (Group 1): Number of Participants With Solicited Local AEs 7 Days Post Second Vaccination | 7 Participants |
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.
Time frame: 7 days post dose 2 (up to Day 36)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Part 2 (Group 1): Number of Participants With Solicited Systemic AEs 7 Days Post Second Vaccination | 83 Participants |
| Healthy (Part 1, Part 2; Group 2): Placebo | Part 2 (Group 1): Number of Participants With Solicited Systemic AEs 7 Days Post Second Vaccination | 20 Participants |
| HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Part 2 (Group 1): Number of Participants With Solicited Systemic AEs 7 Days Post Second Vaccination | 80 Participants |
| HIV-infected (Part 1, Part 2; Group 2): Placebo | Part 2 (Group 1): Number of Participants With Solicited Systemic AEs 7 Days Post Second Vaccination | 10 Participants |
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.
Time frame: Up to 28 days post dose 2 visit (up to Day 57)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Part 2 (Group 1): Number of Participants With Unsolicited Adverse Events | 83 Participants |
| Healthy (Part 1, Part 2; Group 2): Placebo | Part 2 (Group 1): Number of Participants With Unsolicited Adverse Events | 21 Participants |
| HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Part 2 (Group 1): Number of Participants With Unsolicited Adverse Events | 78 Participants |
| HIV-infected (Part 1, Part 2; Group 2): Placebo | Part 2 (Group 1): Number of Participants With Unsolicited Adverse Events | 15 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.
Time frame: 7 days post dose 1 (up to Day 8)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Parts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) 7 Days Post First Vaccination | 46 Participants |
| Healthy (Part 1, Part 2; Group 2): Placebo | Parts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) 7 Days Post First Vaccination | 5 Participants |
| HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Parts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) 7 Days Post First Vaccination | 34 Participants |
| HIV-infected (Part 1, Part 2; Group 2): Placebo | Parts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) 7 Days Post First Vaccination | 3 Participants |
| Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants) | Parts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) 7 Days Post First Vaccination | 71 Participants |
| Part 2 (Group 1): Placebo (Healthy Participants) | Parts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) 7 Days Post First Vaccination | 10 Participants |
| Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants) | Parts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) 7 Days Post First Vaccination | 75 Participants |
| Part 2 (Group 1): Placebo (HIV-infected Participants) | Parts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) 7 Days Post First Vaccination | 7 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.
Time frame: 7 days post dose 1 (up to Day 8)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Parts 1 and 2: Number of Participants With Solicited Systemic Adverse Events 7 Days Post First Vaccination | 39 Participants |
| Healthy (Part 1, Part 2; Group 2): Placebo | Parts 1 and 2: Number of Participants With Solicited Systemic Adverse Events 7 Days Post First Vaccination | 10 Participants |
| HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Parts 1 and 2: Number of Participants With Solicited Systemic Adverse Events 7 Days Post First Vaccination | 37 Participants |
| HIV-infected (Part 1, Part 2; Group 2): Placebo | Parts 1 and 2: Number of Participants With Solicited Systemic Adverse Events 7 Days Post First Vaccination | 7 Participants |
| Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants) | Parts 1 and 2: Number of Participants With Solicited Systemic Adverse Events 7 Days Post First Vaccination | 109 Participants |
| Part 2 (Group 1): Placebo (Healthy Participants) | Parts 1 and 2: Number of Participants With Solicited Systemic Adverse Events 7 Days Post First Vaccination | 24 Participants |
| Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants) | Parts 1 and 2: Number of Participants With Solicited Systemic Adverse Events 7 Days Post First Vaccination | 97 Participants |
| Part 2 (Group 1): Placebo (HIV-infected Participants) | Parts 1 and 2: Number of Participants With Solicited Systemic Adverse Events 7 Days Post First Vaccination | 18 Participants |
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Number of Participants With Adverse Events | Unsolicited AEs | 33 Participants |
| Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Number of Participants With Adverse Events | Solicited Systemic AEs | 56 Participants |
| Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Number of Participants With Adverse Events | Solicited Local AEs | 56 Participants |
| Healthy (Part 1, Part 2; Group 2): Placebo | Number of Participants With Adverse Events | Unsolicited AEs | 32 Participants |
| Healthy (Part 1, Part 2; Group 2): Placebo | Number of Participants With Adverse Events | Solicited Systemic AEs | 46 Participants |
| Healthy (Part 1, Part 2; Group 2): Placebo | Number of Participants With Adverse Events | Solicited Local AEs | 47 Participants |
| HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Number of Participants With Adverse Events | Solicited Local AEs | 103 Participants |
| HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Number of Participants With Adverse Events | Unsolicited AEs | 83 Participants |
| HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV | Number of Participants With Adverse Events | Solicited Systemic AEs | 116 Participants |
| HIV-infected (Part 1, Part 2; Group 2): Placebo | Number of Participants With Adverse Events | Unsolicited AEs | 78 Participants |
| HIV-infected (Part 1, Part 2; Group 2): Placebo | Number of Participants With Adverse Events | Solicited Systemic AEs | 117 Participants |
| HIV-infected (Part 1, Part 2; Group 2): Placebo | Number of Participants With Adverse Events | Solicited Local AEs | 93 Participants |