A Study to Assess Safety, Tolerability, and Immunogenicity of Three Heterologus 2-dose Regimens of the Candidate Prophylactic Vaccines for Ebola in Healthy Adults
Sponsor
Janssen Vaccines & Prevention B.V. (Industry)
Overall Status
Completed
CT.gov ID
NCT02416453
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France (Other), University of Oxford (Other)
423
11
3
31.2
38.5
1.2
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of 3 vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This is a randomized, observer-blind, placebo-controlled, parallel-group, multicenter, Phase 2 study evaluating the safety, tolerability and immunogenicity of 2-dose heterologous regimens using Ad26.ZEBOV and MVA-BN-Filo administered to healthy adults participants in Europe. The study involves a screening period of up to 12 weeks, a vaccination period in which participants will be vaccinated with Ad26.ZEBOV (dose 1) followed by vaccination with MVA-BN-Filo (dose 2) 28, 56 or 84 days later, and a post-vaccination phase until 6 months post dose 2 visit (Days 209, 237 or 265). After unblinding, only participants who received Ad26.ZEBOV and/or MVA-BN-Filo will continue the study until the Day 365 visit (or until the start of the roll-over study or for an additional 12 months [whichever comes first] for participants in France who agree to continue the long-term follow-up after Day 365) to assess long-term safety and immunogenicity. Participants will enroll into 3 cohorts: that is, Cohort 1 (Participants will receive Ad26.ZEBOV and MVA-BN-Filo in an open-label fashion), Cohort 2 (Participants will be randomized to receive the 2-dose heterologous vaccine regimen with either Ad26.ZEBOV followed by MVA-BN-Filo, or placebo in a 14:1 ratio) and Cohort 3 (Participants will be randomized to receive the 2-dose heterologous vaccine regimen with either Ad26.ZEBOV followed by MVA-BN-Filo, or placebo in a 10:3 ratio). In Cohorts 2 and 3, core immunogenicity assessments (humoral and cellular assays) will be performed. In Cohort 2, additional immunogenicity assessments will be done. In Cohort 1, plasma blast response kinetics will be evaluated. Safety will be monitored during the study.
Study Design
Study Type:
Interventional
Actual Enrollment
:
423 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Observer-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Prime-Boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo in Healthy Adults in Europe
Actual Study Start Date
:
Jun 15, 2015
Actual Primary Completion Date
:
Jan 19, 2018
Actual Study Completion Date
:
Jan 19, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1 Participants will receive intramuscular (IM) injection of Ad26.ZEBOV/Placebo on Day 1 followed by IM injection of MVA-BN-Filo/Placebo on Day 29. |
Biological: MVA-BN-Filo
One 0.5 mL intramuscular (IM) injection of 1E8 Infectious Unit [Inf. U.] on Day 29, 57, or 85.
Biological: Ad26.ZEBOV
One 0.5 mL IM injection of 5E10 viral particles (vp) on Day 1.
Biological: Placebo
One 0.5 mL IM injection of 0.9% saline on Day 1 and Day 29, 57, or 85.
|
| Experimental: Group 2 Participants will receive IM injection of Ad26.ZEBOV/Placebo on Day 1 followed by IM injection of MVA-BN-Filo/Placebo on Day 57. |
Biological: MVA-BN-Filo
One 0.5 mL intramuscular (IM) injection of 1E8 Infectious Unit [Inf. U.] on Day 29, 57, or 85.
Biological: Ad26.ZEBOV
One 0.5 mL IM injection of 5E10 viral particles (vp) on Day 1.
Biological: Placebo
One 0.5 mL IM injection of 0.9% saline on Day 1 and Day 29, 57, or 85.
|
| Experimental: Group 3 Participants will receive IM injection of Ad26.ZEBOV/Placebo on Day 1 followed by IM injection of MVA-BN-Filo/Placebo on Day 85. |
Biological: MVA-BN-Filo
One 0.5 mL intramuscular (IM) injection of 1E8 Infectious Unit [Inf. U.] on Day 29, 57, or 85.
Biological: Ad26.ZEBOV
One 0.5 mL IM injection of 5E10 viral particles (vp) on Day 1.
Biological: Placebo
One 0.5 mL IM injection of 0.9% saline on Day 1 and Day 29, 57, or 85.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Unsolicited Adverse Events (Groups 1, 2 and 3) [Up to 42-day post dose 2 visit (Day 1 to Day 127)]
An adverse event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal product, it does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal product. Unsolicited adverse events were events which were reported by the participant voluntarily or obtained by means of interviewing the participant in a nondirected manner at study visits.
- Number of Participants With Serious Adverse Events (Groups 1, 2 and 3) [Up to Day 365]
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
- Number of Participants With Immediate Reportable Events (Groups 1, 2 and 3) [Up to Day 365]
The following neuroinflammatory disorders were considered immediate reportable events and which had to be reported to the sponsor within 24 hours of becoming aware of the event. Neuroinflammatory disorders included: cranial nerve disorders including paralyses/paresis (example: bell's palsy), optic neuritis, multiple sclerosis, transverse myelitis, guillain-barre syndrome including miller fisher syndrome, bickerstaff's encephalitis and other variants, acute disseminated encephalomyelitis, including site-specific variants (example: non-infectious encephalitis, encephalomyelitis, myelitis, 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 (Groups 1, 2 and 3) [7 days post-dose 1 (Day 8)]
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post first vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
- Number of Participants With Solicited Local Adverse Events (Groups 1, 2 and 3) [7 days post-dose 2 (Up to Day 92)]
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post first vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
- Number of Participants With Solicited Systemic Adverse Events (Groups 1, 2 and 3) [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 (Groups 1, 2 and 3) [7 days post-dose 2 (Up to Day 92)]
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Secondary Outcome Measures
- Number of Participants With Unsolicited Adverse Events (Group 4) [Up to 28-day post dose 1 (Day 29)]
An AE is any untoward medical occurrence in a clinical study subject administered a medicinal product, it does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal product. Unsolicited adverse events were events which were reported by the participant voluntarily or obtained by means of interviewing the participant in a nondirected manner at study visits.
- Number of Participants With Serious Adverse Events (Group 4) [Up to Day 180]
A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
- Number of Participants With Immediate Reportable Events (Group 4) [Up to Day 180]
The following neuroinflammatory disorders were considered immediate reportable events which had to be reported to the sponsor within 24 hours of becoming aware of the event. Neuroinflammatory disorders included: cranial nerve disorders including paralyses/paresis (example: bell's palsy), optic neuritis, multiple sclerosis, transverse myelitis, guillain-barre syndrome including miller fisher syndrome, bickerstaff's encephalitis and other variants, acute disseminated encephalomyelitis, including site-specific variants (example: non-infectious encephalitis, encephalomyelitis, myelitis, 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 (Group 4) [7 days after each vaccination (Up to Day 8)]
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post first vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
- Number of Participants With Solicited Systemic Adverse Events (Group 4) [7 days after each vaccination (Up to Day 8)]
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
- Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Filovirus Animal Non-Clinical Group (FANG) Enzyme-linked Immunosorbent Assay (ELISA) (Groups 1, 2 and 3) [At 21-days post dose 2 (Day 50 for Group 1; Day 78 for Group 2; and Day 106 for Group 3)]
GMCs of antibodies binding to EBOV GP using FANG ELISA were reported and were measured in ELISA unit per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using FANG ELISA to determine humoral responses following vaccination. For ELISA binding antibody responses, values below the lower limit of quantification (LLOQ) (36.11 ELISA units/mL). The outcome measure was planned to be reported at 21-day post dose 2. Therefore, the results are reported for Group 1, 2 and 3 only.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Must be healthy in the Investigator's clinical judgment on the basis of medical history, physical examination, electrocardiogram (ECG) and vital signs performed at Screening
-
Must be healthy on the basis of clinical laboratory tests performed at Screening. If the results of the laboratory screening tests are outside the normal reference ranges, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study
-
Before randomization, a woman must be either of childbearing potential and practicing (or intending to practice) a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for participants participating in clinical studies, beginning at least 28 days prior to vaccination OR not of childbearing potential: postmenopausal (greater than [>] 45 years of age with amenorrhea for at least 2 years or lesser than or equal to [<=] 45 years of age with amenorrhea for at least 6 months, and a serum follicle stimulating hormone (FSH) level
40 international unit per milliliter [IU/L]); permanently sterilized (for example, bilateral tubal occlusion [which includes tubal ligation procedures as consistent with local regulations], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy
-
Woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) at Screening and a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration
-
Man who is sexually active with a woman of childbearing potential and has not had a vasectomy performed more than 1 year prior to screening must be willing to use condoms for sexual intercourse beginning prior to enrollment
Exclusion Criteria:
-
Having received any candidate Ebola vaccine
-
Diagnosed with Ebola virus disease, or prior exposure to Ebola virus, including travel to West Africa less than 1 month prior to screening. West Africa includes but is not limited to the countries of Guinea, Liberia, Mali, and Sierra Leone
-
Having received any experimental candidate adenovirus serotype 26 (vector: Ad26) or Modified Vaccinia Ankara (MVA-) based vaccine in the past
-
Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccines including known allergy to egg, egg products and aminoglycosides
-
Presence of acute illness or temperature greater than or equal to 38.0 C on Day 1
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Creteil | France | |||
| 2 | Marseille | France | |||
| 3 | Paris | France | |||
| 4 | Pierre Benite | France | |||
| 5 | Rennes | France | |||
| 6 | Saint Etienne | France | |||
| 7 | Strasbourg | France | |||
| 8 | Tours | France | |||
| 9 | London | United Kingdom | |||
| 10 | Oxford | United Kingdom | |||
| 11 | Southampton | United Kingdom |
Sponsors and Collaborators
- Janssen Vaccines & Prevention B.V.
- Institut National de la Santé Et de la Recherche Médicale, France
- University of Oxford
Investigators
- Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial, Janssen Vaccines & Prevention B.V.
- Study Director: Inserm Clinical Trials, Institut National de la Santé Et de la Recherche Médicale, France
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier:
NCT02416453
Other Study ID Numbers:
- CR107227
- VAC52150EBL2001
- 2015-000596-27
First Posted:
Apr 15, 2015
Last Update Posted:
Feb 8, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Janssen Vaccines & Prevention B.V.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | A total of 423 participants were randomized (408 participants in Groups 1 to 3 and 15 participants in Group 4). Among them, 421 participants received at least one dose of study vaccines. Two participants were randomized but not vaccinated. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval) | Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 1: Pooled Cohorts II and III: Placebo | Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 2: Pooled Cohorts II and III: Placebo | Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval) | Group 3: Pooled Cohorts II and III: Placebo | Group 4: Ad26.ZEBOV | Group 4: Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5*10^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29. | Participants received IM injection of placebo on Day 1 and Day 29. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57. | Participants received IM injection of placebo on Day 1 and Day 57. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85. | Participants received IM injection of placebo on Day 1 and Day 85. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp on Day 1. | Participants received IM injection of placebo Day 1. |
| Period Title: Overall Study | |||||||||||
| STARTED | 10 | 10 | 10 | 112 | 13 | 114 | 13 | 106 | 18 | 13 | 2 |
| COMPLETED | 7 | 7 | 9 | 97 | 12 | 98 | 11 | 94 | 13 | 13 | 2 |
| NOT COMPLETED | 3 | 3 | 1 | 15 | 1 | 16 | 2 | 12 | 5 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval) | Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 1: Pooled Cohorts II and III: Placebo | Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 2: Pooled Cohorts II and III: Placebo | Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval) | Group 3: Pooled Cohorts II and III: Placebo | Group 4: Ad26.ZEBOV | Group 4: Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5*10^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29. | Participants received IM injection of placebo on Day 1 and Day 29. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57. | Participants received IM injection of placebo on Day 1 and Day 57. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85. | Participants received IM injection of placebo on Day 1 and Day 85. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp on Day 1. | Participants received IM injection of placebo Day 1. | Total of all reporting groups |
| Overall Participants | 10 | 10 | 10 | 112 | 13 | 114 | 13 | 106 | 18 | 13 | 2 | 421 |
| Age (years) [Mean (Standard Deviation) ] | ||||||||||||
| Mean (Standard Deviation) [years] |
34.2
(12.95)
|
47.4
(16.53)
|
38.7
(13.99)
|
41
(15)
|
39.1
(13.9)
|
41
(14.02)
|
38.2
(13.66)
|
38.3
(14.34)
|
41.1
(15.11)
|
37.9
(11.37)
|
47
(4.24)
|
40
(14.32)
|
| Sex: Female, Male (Count of Participants) | ||||||||||||
| Female |
4
40%
|
6
60%
|
7
70%
|
57
50.9%
|
6
46.2%
|
62
54.4%
|
8
61.5%
|
53
50%
|
10
55.6%
|
3
23.1%
|
1
50%
|
217
51.5%
|
| Male |
6
60%
|
4
40%
|
3
30%
|
55
49.1%
|
7
53.8%
|
52
45.6%
|
5
38.5%
|
53
50%
|
8
44.4%
|
10
76.9%
|
1
50%
|
204
48.5%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||||||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
3
2.7%
|
0
0%
|
3
2.6%
|
1
7.7%
|
5
4.7%
|
1
5.6%
|
0
0%
|
0
0%
|
13
3.1%
|
| Black or African American |
0
0%
|
0
0%
|
2
20%
|
10
8.9%
|
1
7.7%
|
8
7%
|
2
15.4%
|
9
8.5%
|
1
5.6%
|
3
23.1%
|
0
0%
|
36
8.6%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White |
10
100%
|
9
90%
|
8
80%
|
97
86.6%
|
12
92.3%
|
102
89.5%
|
10
76.9%
|
89
84%
|
16
88.9%
|
10
76.9%
|
2
100%
|
365
86.7%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
1
0.9%
|
0
0%
|
0
0%
|
0
0%
|
2
1.9%
|
0
0%
|
0
0%
|
0
0%
|
3
0.7%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Other |
0
0%
|
1
10%
|
0
0%
|
1
0.9%
|
0
0%
|
1
0.9%
|
0
0%
|
1
0.9%
|
0
0%
|
0
0%
|
0
0%
|
4
1%
|
| Region of Enrollment (Count of Participants) | ||||||||||||
| France |
0
0%
|
0
0%
|
0
0%
|
54
48.2%
|
7
53.8%
|
55
48.2%
|
7
53.8%
|
50
47.2%
|
9
50%
|
13
100%
|
2
100%
|
197
46.8%
|
| United Kingdom |
10
100%
|
10
100%
|
10
100%
|
58
51.8%
|
6
46.2%
|
59
51.8%
|
6
46.2%
|
56
52.8%
|
9
50%
|
0
0%
|
0
0%
|
224
53.2%
|
Outcome Measures
| Title | Number of Participants With Unsolicited Adverse Events (Groups 1, 2 and 3) |
|---|---|
| Description | An adverse event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal product, it does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal product. Unsolicited adverse events were events which were reported by the participant voluntarily or obtained by means of interviewing the participant in a nondirected manner at study visits. |
| Time Frame | Up to 42-day post dose 2 visit (Day 1 to Day 127) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations. |
| Arm/Group Title | Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval) | Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 1: Pooled Cohorts II and III: Placebo | Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 2: Pooled Cohorts II and III: Placebo | Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval) | Group 3: Pooled Cohorts II and III: Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5*10^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29. | Participants received IM injection of placebo on Day 1 and Day 29. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57. | Participants received IM injection of placebo on Day 1 and Day 57. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85. | Participants received IM injection of placebo on Day 1 and Day 85. |
| Measure Participants | 10 | 10 | 10 | 112 | 13 | 114 | 13 | 106 | 18 |
| Count of Participants [Participants] |
4
40%
|
6
60%
|
6
60%
|
62
55.4%
|
6
46.2%
|
52
45.6%
|
7
53.8%
|
46
43.4%
|
8
44.4%
|
| Title | Number of Participants With Serious Adverse Events (Groups 1, 2 and 3) |
|---|---|
| Description | 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 Day 365 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations. |
| Arm/Group Title | Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval) | Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 1: Pooled Cohorts II and III: Placebo | Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 2: Pooled Cohorts II and III: Placebo | Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval) | Group 3: Pooled Cohorts II and III: Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5*10^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29. | Participants received IM injection of placebo on Day 1 and Day 29. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57. | Participants received IM injection of placebo on Day 1 and Day 57. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85. | Participants received IM injection of placebo on Day 1 and Day 85. |
| Measure Participants | 10 | 10 | 10 | 112 | 13 | 114 | 13 | 106 | 18 |
| Count of Participants [Participants] |
0
0%
|
1
10%
|
0
0%
|
2
1.8%
|
0
0%
|
4
3.5%
|
1
7.7%
|
5
4.7%
|
1
5.6%
|
| Title | Number of Participants With Immediate Reportable Events (Groups 1, 2 and 3) |
|---|---|
| Description | The following neuroinflammatory disorders were considered immediate reportable events and which had to be reported to the sponsor within 24 hours of becoming aware of the event. Neuroinflammatory disorders included: cranial nerve disorders including paralyses/paresis (example: bell's palsy), optic neuritis, multiple sclerosis, transverse myelitis, guillain-barre syndrome including miller fisher syndrome, bickerstaff's encephalitis and other variants, acute disseminated encephalomyelitis, including site-specific variants (example: non-infectious encephalitis, encephalomyelitis, myelitis, myeloradiculomyelitis), myasthenia gravis and lambert-eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, including chronic inflammatory, demyelinating polyneuropathy, multifocal motor neuropathy, and polyneuropathies associated with monoclonal gammopathy, narcolepsy, isolated paresthesia of more than 7 days duration. |
| Time Frame | Up to Day 365 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations. |
| Arm/Group Title | Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval) | Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 1: Pooled Cohorts II and III: Placebo | Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 2: Pooled Cohorts II and III: Placebo | Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval) | Group 3: Pooled Cohorts II and III: Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5*10^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29. | Participants received IM injection of placebo on Day 1 and Day 29. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57. | Participants received IM injection of placebo on Day 1 and Day 57. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85. | Participants received IM injection of placebo on Day 1 and Day 85. |
| Measure Participants | 10 | 10 | 10 | 112 | 13 | 114 | 13 | 106 | 18 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
1.8%
|
0
0%
|
2
1.9%
|
0
0%
|
| Title | Number of Participants With Solicited Local Adverse Events (Groups 1, 2 and 3) |
|---|---|
| Description | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post first vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site. |
| Time Frame | 7 days post-dose 1 (Day 8) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations. |
| Arm/Group Title | Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval) | Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 1: Pooled Cohorts II and III: Placebo | Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 2: Pooled Cohorts II and III: Placebo | Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval) | Group 3: Pooled Cohorts II and III: Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5*10^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29. | Participants received IM injection of placebo on Day 1 and Day 29. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57. | Participants received IM injection of placebo on Day 1 and Day 57. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85. | Participants received IM injection of placebo on Day 1 and Day 85. |
| Measure Participants | 10 | 10 | 10 | 112 | 13 | 114 | 13 | 106 | 18 |
| Count of Participants [Participants] |
8
80%
|
6
60%
|
8
80%
|
63
56.3%
|
3
23.1%
|
65
57%
|
2
15.4%
|
78
73.6%
|
4
22.2%
|
| Title | Number of Participants With Solicited Local Adverse Events (Groups 1, 2 and 3) |
|---|---|
| Description | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post first vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site. |
| Time Frame | 7 days post-dose 2 (Up to Day 92) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. |
| Arm/Group Title | Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval) | Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 1: Pooled Cohorts II and III: Placebo | Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 2: Pooled Cohorts II and III: Placebo | Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval) | Group 3: Pooled Cohorts II and III: Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5*10^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29. | Participants received IM injection of placebo on Day 1 and Day 29. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57. | Participants received IM injection of placebo on Day 1 and Day 57. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85. | Participants received IM injection of placebo on Day 1 and Day 85. |
| Measure Participants | 8 | 9 | 9 | 91 | 10 | 83 | 7 | 62 | 11 |
| Count of Participants [Participants] |
4
40%
|
5
50%
|
8
80%
|
46
41.1%
|
2
15.4%
|
49
43%
|
0
0%
|
41
38.7%
|
0
0%
|
| Title | Number of Participants With Solicited Systemic Adverse Events (Groups 1, 2 and 3) |
|---|---|
| Description | 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 | 7 days post-dose 1 (Day 8) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations. |
| Arm/Group Title | Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval) | Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 1: Pooled Cohorts II and III: Placebo | Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 2: Pooled Cohorts II and III: Placebo | Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval) | Group 3: Pooled Cohorts II and III: Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5*10^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29. | Participants received IM injection of placebo on Day 1 and Day 29. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57. | Participants received IM injection of placebo on Day 1 and Day 57. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85. | Participants received IM injection of placebo on Day 1 and Day 85. |
| Measure Participants | 10 | 10 | 10 | 112 | 13 | 114 | 13 | 106 | 18 |
| Count of Participants [Participants] |
8
80%
|
10
100%
|
10
100%
|
89
79.5%
|
7
53.8%
|
84
73.7%
|
8
61.5%
|
82
77.4%
|
7
38.9%
|
| Title | Number of Participants With Solicited Systemic Adverse Events (Groups 1, 2 and 3) |
|---|---|
| Description | 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 | 7 days post-dose 2 (Up to Day 92) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. |
| Arm/Group Title | Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval) | Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 1: Pooled Cohorts II and III: Placebo | Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 2: Pooled Cohorts II and III: Placebo | Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval) | Group 3: Pooled Cohorts II and III: Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5*10^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29. | Participants received IM injection of placebo on Day 1 and Day 29. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57. | Participants received IM injection of placebo on Day 1 and Day 57. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85. | Participants received IM injection of placebo on Day 1 and Day 85. |
| Measure Participants | 8 | 9 | 9 | 91 | 10 | 83 | 7 | 62 | 11 |
| Count of Participants [Participants] |
6
60%
|
5
50%
|
5
50%
|
42
37.5%
|
5
38.5%
|
36
31.6%
|
2
15.4%
|
38
35.8%
|
4
22.2%
|
| Title | Number of Participants With Unsolicited Adverse Events (Group 4) |
|---|---|
| Description | An AE is any untoward medical occurrence in a clinical study subject administered a medicinal product, it does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal product. Unsolicited adverse events were events which were reported by the participant voluntarily or obtained by means of interviewing the participant in a nondirected manner at study visits. |
| Time Frame | Up to 28-day post dose 1 (Day 29) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations. |
| Arm/Group Title | Group 4: Ad26.ZEBOV | Group 4: Placebo |
|---|---|---|
| Arm/Group Description | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp on Day 1. | Participants received IM injection of placebo Day 1. |
| Measure Participants | 13 | 2 |
| Count of Participants [Participants] |
6
60%
|
1
10%
|
| Title | Number of Participants With Serious Adverse Events (Group 4) |
|---|---|
| Description | A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Time Frame | Up to Day 180 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations. |
| Arm/Group Title | Group 4: Ad26.ZEBOV | Group 4: Placebo |
|---|---|---|
| Arm/Group Description | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp on Day 1. | Participants received IM injection of placebo Day 1. |
| Measure Participants | 13 | 2 |
| Count of Participants [Participants] |
2
20%
|
0
0%
|
| Title | Number of Participants With Immediate Reportable Events (Group 4) |
|---|---|
| Description | 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 Day 180 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations. |
| Arm/Group Title | Group 4: Ad26.ZEBOV | Group 4: Placebo |
|---|---|---|
| Arm/Group Description | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp on Day 1. | Participants received IM injection of placebo Day 1. |
| Measure Participants | 13 | 2 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| Title | Number of Participants With Solicited Local Adverse Events (Group 4) |
|---|---|
| Description | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post first vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site. |
| Time Frame | 7 days after each vaccination (Up to Day 8) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations. |
| Arm/Group Title | Group 4: Ad26.ZEBOV | Group 4: Placebo |
|---|---|---|
| Arm/Group Description | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp on Day 1. | Participants received IM injection of placebo Day 1. |
| Measure Participants | 13 | 2 |
| Count of Participants [Participants] |
8
80%
|
0
0%
|
| Title | Number of Participants With Solicited Systemic Adverse Events (Group 4) |
|---|---|
| Description | 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 | 7 days after each vaccination (Up to Day 8) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations. |
| Arm/Group Title | Group 4: Ad26.ZEBOV | Group 4: Placebo |
|---|---|---|
| Arm/Group Description | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp on Day 1. | Participants received IM injection of placebo Day 1. |
| Measure Participants | 13 | 2 |
| Count of Participants [Participants] |
11
110%
|
1
10%
|
| Title | Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Filovirus Animal Non-Clinical Group (FANG) Enzyme-linked Immunosorbent Assay (ELISA) (Groups 1, 2 and 3) |
|---|---|
| Description | GMCs of antibodies binding to EBOV GP using FANG ELISA were reported and were measured in ELISA unit per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using FANG ELISA to determine humoral responses following vaccination. For ELISA binding antibody responses, values below the lower limit of quantification (LLOQ) (36.11 ELISA units/mL). The outcome measure was planned to be reported at 21-day post dose 2. Therefore, the results are reported for Group 1, 2 and 3 only. |
| Time Frame | At 21-days post dose 2 (Day 50 for Group 1; Day 78 for Group 2; and Day 106 for Group 3) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The per protocol analysis set included all randomized and vaccinated participants, who received both the prime and boost vaccinations (administered within the protocol-defined window), have at least 1 post-vaccination (that is, after the date of vaccination) evaluable immunogenicity sample, and have no major protocol violations influencing the immune response. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. |
| Arm/Group Title | Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 1: Pooled Cohorts II and III: Placebo | Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 2: Pooled Cohorts II and III: Placebo | Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval) | Group 3: Pooled Cohorts II and III: Placebo |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29. | Participants received IM injection of placebo on Day 1 and Day 29. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57. | Participants received IM injection of placebo on Day 1 and Day 57. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85. | Participants received IM injection of placebo on Day 1 and Day 85. |
| Measure Participants | 77 | 7 | 69 | 7 | 48 | 6 |
| Geometric Mean (95% Confidence Interval) [EU/mL] |
4627
|
NA
|
10131
|
NA
|
11312
|
NA
|
Adverse Events
| Time Frame | Up to Day 365 | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations. | |||||||||||||||||||||
| Arm/Group Title | Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval) | Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 1: Pooled Cohorts II and III: Placebo | Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 2: Pooled Cohorts II and III: Placebo | Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval) | Group 3: Pooled Cohorts II and III: Placebo | Group 4: Ad26.ZEBOV | Group 4: Placebo | |||||||||||
| Arm/Group Description | Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5*10^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 29. | Participants received IM injection of placebo on Day 1 and Day 29. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 57. | Participants received IM injection of placebo on Day 1 and Day 57. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1*10^8 Inf.U (nominal titer) as dose 2 on Day 85. | Participants received IM injection of placebo on Day 1 and Day 85. | Participants received IM injection of Ad26.ZEBOV at 5*10^10 vp on Day 1. | Participants received IM injection of placebo Day 1. | |||||||||||
All Cause Mortality |
||||||||||||||||||||||
| Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval) | Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 1: Pooled Cohorts II and III: Placebo | Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 2: Pooled Cohorts II and III: Placebo | Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval) | Group 3: Pooled Cohorts II and III: Placebo | Group 4: Ad26.ZEBOV | Group 4: Placebo | ||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
Serious Adverse Events |
||||||||||||||||||||||
| Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval) | Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 1: Pooled Cohorts II and III: Placebo | Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 2: Pooled Cohorts II and III: Placebo | Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval) | Group 3: Pooled Cohorts II and III: Placebo | Group 4: Ad26.ZEBOV | Group 4: Placebo | ||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 2/112 (1.8%) | 0/13 (0%) | 4/114 (3.5%) | 1/13 (7.7%) | 5/106 (4.7%) | 1/18 (5.6%) | 2/13 (15.4%) | 0/2 (0%) | |||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||||
| Haemorrhoids | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 1/13 (7.7%) | 0/2 (0%) | |||||||||||
| Inguinal hernia | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 1/106 (0.9%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Hepatobiliary disorders | ||||||||||||||||||||||
| Cholecystitis acute | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Immune system disorders | ||||||||||||||||||||||
| Food allergy | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 1/106 (0.9%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Infections and infestations | ||||||||||||||||||||||
| Cellulitis | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 1/106 (0.9%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Chronic sinusitis | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/112 (0.9%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Hepatitis A | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 1/114 (0.9%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Investigations | ||||||||||||||||||||||
| Human papilloma virus test positive | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 0/114 (0%) | 1/13 (7.7%) | 0/106 (0%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||||||
| Breast cancer | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/112 (0.9%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Osteosarcoma | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 0/106 (0%) | 1/18 (5.6%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Nervous system disorders | ||||||||||||||||||||||
| Cerebral venous thrombosis | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 1/106 (0.9%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Miller Fisher syndrome | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 1/114 (0.9%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Small fibre neuropathy | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 1/13 (7.7%) | 0/2 (0%) | |||||||||||
| Pregnancy, puerperium and perinatal conditions | ||||||||||||||||||||||
| Abortion spontaneous | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 1/114 (0.9%) | 0/13 (0%) | 1/106 (0.9%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Surgical and medical procedures | ||||||||||||||||||||||
| Appendicectomy | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 1/114 (0.9%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||||
| Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval) | Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) | Group 1: Pooled Cohorts II and III: Placebo | Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) | Group 2: Pooled Cohorts II and III: Placebo | Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval) | Group 3: Pooled Cohorts II and III: Placebo | Group 4: Ad26.ZEBOV | Group 4: Placebo | ||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/10 (40%) | 5/10 (50%) | 6/10 (60%) | 41/112 (36.6%) | 6/13 (46.2%) | 30/114 (26.3%) | 7/13 (53.8%) | 26/106 (24.5%) | 8/18 (44.4%) | 6/13 (46.2%) | 1/2 (50%) | |||||||||||
| Ear and labyrinth disorders | ||||||||||||||||||||||
| Vertigo | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/112 (0%) | 1/13 (7.7%) | 1/114 (0.9%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||||
| Dental discomfort | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 1/114 (0.9%) | 1/13 (7.7%) | 0/106 (0%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Diarrhoea | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 1/114 (0.9%) | 0/13 (0%) | 1/106 (0.9%) | 1/18 (5.6%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Nausea | 0/10 (0%) | 0/10 (0%) | 2/10 (20%) | 0/112 (0%) | 0/13 (0%) | 2/114 (1.8%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Odynophagia | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 0/114 (0%) | 1/13 (7.7%) | 0/106 (0%) | 0/18 (0%) | 1/13 (7.7%) | 0/2 (0%) | |||||||||||
| Oral pain | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 0/106 (0%) | 1/18 (5.6%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Toothache | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/112 (0%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 1/106 (0.9%) | 1/18 (5.6%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Vomiting | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/112 (0%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| General disorders | ||||||||||||||||||||||
| Application site bruise | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 0/106 (0%) | 1/18 (5.6%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Asthenia | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 1/114 (0.9%) | 0/13 (0%) | 0/106 (0%) | 1/18 (5.6%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Influenza like illness | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 2/112 (1.8%) | 0/13 (0%) | 2/114 (1.8%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 1/13 (7.7%) | 0/2 (0%) | |||||||||||
| Injection site erythema | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 1/112 (0.9%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Injection site pain | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/112 (0%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Pyrexia | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 0/106 (0%) | 1/18 (5.6%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Infections and infestations | ||||||||||||||||||||||
| Cellulitis | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Conjunctivitis | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/112 (0%) | 1/13 (7.7%) | 0/114 (0%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Nasopharyngitis | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 3/112 (2.7%) | 0/13 (0%) | 0/114 (0%) | 1/13 (7.7%) | 1/106 (0.9%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Pharyngitis | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 2/112 (1.8%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 0/106 (0%) | 1/18 (5.6%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Rhinitis | 1/10 (10%) | 1/10 (10%) | 1/10 (10%) | 7/112 (6.3%) | 0/13 (0%) | 6/114 (5.3%) | 0/13 (0%) | 3/106 (2.8%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Tooth abscess | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 1/114 (0.9%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Upper respiratory tract infection | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 6/112 (5.4%) | 1/13 (7.7%) | 6/114 (5.3%) | 1/13 (7.7%) | 3/106 (2.8%) | 1/18 (5.6%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Urinary tract infection | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/112 (0.9%) | 1/13 (7.7%) | 0/114 (0%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||||||
| Ligament sprain | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/112 (0.9%) | 1/13 (7.7%) | 0/114 (0%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 1/13 (7.7%) | 0/2 (0%) | |||||||||||
| Investigations | ||||||||||||||||||||||
| Alanine aminotransferase increased | 1/10 (10%) | 1/10 (10%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 1/114 (0.9%) | 0/13 (0%) | 3/106 (2.8%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Aspartate aminotransferase increased | 1/10 (10%) | 1/10 (10%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 3/114 (2.6%) | 0/13 (0%) | 3/106 (2.8%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Blood creatinine increased | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 1/112 (0.9%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Neutrophil count decreased | 1/10 (10%) | 1/10 (10%) | 2/10 (20%) | 3/112 (2.7%) | 0/13 (0%) | 2/114 (1.8%) | 0/13 (0%) | 2/106 (1.9%) | 1/18 (5.6%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Prothrombin time prolonged | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/112 (0.9%) | 0/13 (0%) | 1/114 (0.9%) | 1/13 (7.7%) | 0/106 (0%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||
| Arthralgia | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/112 (0.9%) | 0/13 (0%) | 1/114 (0.9%) | 1/13 (7.7%) | 0/106 (0%) | 1/18 (5.6%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Back pain | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 3/112 (2.7%) | 0/13 (0%) | 1/114 (0.9%) | 1/13 (7.7%) | 3/106 (2.8%) | 0/18 (0%) | 2/13 (15.4%) | 0/2 (0%) | |||||||||||
| Chondropathy | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 0/13 (0%) | 1/2 (50%) | |||||||||||
| Musculoskeletal pain | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 2/112 (1.8%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 1/13 (7.7%) | 0/2 (0%) | |||||||||||
| Osteoarthritis | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 1/13 (7.7%) | 0/2 (0%) | |||||||||||
| Pain in extremity | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 1/112 (0.9%) | 0/13 (0%) | 1/114 (0.9%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Nervous system disorders | ||||||||||||||||||||||
| Dizziness postural | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 1/112 (0.9%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 1/106 (0.9%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Dysgeusia | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 1/106 (0.9%) | 1/18 (5.6%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Headache | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 3/112 (2.7%) | 1/13 (7.7%) | 3/114 (2.6%) | 1/13 (7.7%) | 5/106 (4.7%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||
| Asthma | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/112 (0%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Cough | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 2/112 (1.8%) | 0/13 (0%) | 2/114 (1.8%) | 1/13 (7.7%) | 0/106 (0%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Rhinorrhoea | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 4/112 (3.6%) | 0/13 (0%) | 1/114 (0.9%) | 2/13 (15.4%) | 3/106 (2.8%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||||
| Eczema | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 0/106 (0%) | 1/18 (5.6%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Pruritus | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 1/112 (0.9%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
| Urticaria | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/112 (0%) | 0/13 (0%) | 0/114 (0%) | 0/13 (0%) | 0/106 (0%) | 0/18 (0%) | 0/13 (0%) | 0/2 (0%) | |||||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
| Name/Title | Medical Leader |
|---|---|
| Organization | Janssen Research & Development, LLC |
| Phone | 844-434-4210 |
| ClinicalTrialDisclosure@its.jnj.com |
Responsible Party:
Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier:
NCT02416453
Other Study ID Numbers:
- CR107227
- VAC52150EBL2001
- 2015-000596-27
First Posted:
Apr 15, 2015
Last Update Posted:
Feb 8, 2021
Last Verified:
Jan 1, 2021