Safety, Tolerability and Immunogenicity Study of 2-dose Heterologous Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo

• Sponsor: Janssen Vaccines & Prevention B.V. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02598388
• Collaborator: Walter Reed Army Institute of Research (WRAIR) (U.S. Fed)
• Enrollment: 578
• Locations: 7
• Arms: 3
• Actual Duration (Months): 36.1
• Patients Per Site: 82.6
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemorrhagic Fever, Ebola	Biological: Ad26.ZEBOV; Biological: MVA-BN-Filo; Biological: Placebo	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 578 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Randomized, Observer-blind, Placebo-controlled, Two-part, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo
• Actual Study Start Date: Dec 10, 2015
• Actual Primary Completion Date: Dec 12, 2018
• Actual Study Completion Date: Dec 12, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1 (US Participants) Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.ZEBOV or placebo on Day 15.	Biological: Ad26.ZEBOV; One 0.5 mL intramuscular (IM) injection of (5x10*10 viral particles).; Biological: MVA-BN-Filo; One 0.5 mL IM injection of (1x10*8 infectious units).; Biological: Placebo; One 0.5 mL IM injection of 0.9 percent (%) saline.
Experimental: Part 2 Group 1 (African Participants) Participants will receive Ad26.ZEBOV or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 29.	Biological: Ad26.ZEBOV; One 0.5 mL intramuscular (IM) injection of (5x10*10 viral particles).; Biological: MVA-BN-Filo; One 0.5 mL IM injection of (1x10*8 infectious units).; Biological: Placebo; One 0.5 mL IM injection of 0.9 percent (%) saline.
Experimental: Part 2 Group 2 (African Participants) Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.ZEBOV or placebo on Day 15.	Biological: Ad26.ZEBOV; One 0.5 mL intramuscular (IM) injection of (5x10*10 viral particles).; Biological: MVA-BN-Filo; One 0.5 mL IM injection of (1x10*8 infectious units).; Biological: Placebo; One 0.5 mL IM injection of 0.9 percent (%) saline.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

Secondary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Silver Spring	Maryland	United States
2		Kericho		Kenya
3		Kisumu		Kenya
4		Maputo		Mozambique
5		Abuja		Nigeria
6		Mbeya		Tanzania
7		Kampala		Uganda

Sponsors and Collaborators

• Janssen Vaccines & Prevention B.V.
• Walter Reed Army Institute of Research (WRAIR)

Investigators

• Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial, Janssen Vaccines & Prevention B.V.

Study Documents (Full-Text)

• Study Protocol - Sep 18, 2017
• Statistical Analysis Plan - Apr 16, 2019

More Information

Publications

None provided.

• Responsible Party: Janssen Vaccines & Prevention B.V.
• ClinicalTrials.gov Identifier: NCT02598388
• Other Study ID Numbers: CR108062; VAC52150EBL2003
• First Posted: Nov 5, 2015
• Last Update Posted: Feb 18, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Janssen Vaccines & Prevention B.V.: 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
• Additional relevant MeSH terms: Hemorrhagic Fever, Ebola; Hemorrhagic Fevers, Viral

Study Results

Participant Flow

Pre-assignment Detail	Out of 578 randomized participants, 574 received at least one dose of study vaccine.

Arm/Group Title	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)
Arm/Group Description	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Period Title: Overall Study
STARTED	40	10	20	5	161	39	161	39	39	10	40	10
COMPLETED	39	10	18	5	151	38	156	38	39	9	39	10
NOT COMPLETED	1	0	2	0	10	1	5	1	0	1	1	0

Baseline Characteristics

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Total of all reporting groups
Overall Participants	40	10	20	5	161	39	161	39	39	10	40	10	574
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42 (14.42)	47.3 (11.84)	46.7 (12.89)	46 (8.63)	29.1 (7.56)	28.4 (7.37)	37.5 (9.78)	38.9 (8.74)	28 (7.72)	26.9 (12.56)	38.5 (9.91)	41 (9.78)	34.8 (11.02)
Sex: Female, Male (Count of Participants)
Female	18 45%	7 70%	2 10%	1 20%	69 42.9%	19 48.7%	95 59%	22 56.4%	20 51.3%	6 60%	26 65%	4 40%	289 50.3%
Male	22 55%	3 30%	18 90%	4 80%	92 57.1%	20 51.3%	66 41%	17 43.6%	19 48.7%	4 40%	14 35%	6 60%	285 49.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 7.5%	0 0%	2 10%	0 0%	7 4.3%	1 2.6%	3 1.9%	2 5.1%	1 2.6%	1 10%	0 0%	0 0%	20 3.5%
Not Hispanic or Latino	37 92.5%	10 100%	18 90%	5 100%	154 95.7%	38 97.4%	158 98.1%	37 94.9%	38 97.4%	9 90%	40 100%	10 100%	554 96.5%
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%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	2 10%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2 0.3%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
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%	0 0%
Black or African American	19 47.5%	6 60%	13 65%	4 80%	160 99.4%	39 100%	159 98.8%	39 100%	39 100%	10 100%	40 100%	10 100%	538 93.7%
White	21 52.5%	4 40%	5 25%	1 20%	1 0.6%	0 0%	2 1.2%	0 0%	0 0%	0 0%	0 0%	0 0%	34 5.9%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
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%	0 0%
Region of Enrollment (Count of Participants)
KENYA	0 0%	0 0%	0 0%	0 0%	50 31.1%	9 23.1%	79 49.1%	21 53.8%	10 25.6%	6 60%	15 37.5%	7 70%	197 34.3%
MOZAMBIQUE	0 0%	0 0%	0 0%	0 0%	32 19.9%	7 17.9%	23 14.3%	5 12.8%	8 20.5%	3 30%	5 12.5%	0 0%	83 14.5%
NIGERIA	0 0%	0 0%	0 0%	0 0%	17 10.6%	3 7.7%	11 6.8%	1 2.6%	2 5.1%	0 0%	3 7.5%	1 10%	38 6.6%
TANZANIA, UNITED REPUBLIC OF	0 0%	0 0%	0 0%	0 0%	31 19.3%	9 23.1%	14 8.7%	4 10.3%	11 28.2%	1 10%	4 10%	1 10%	75 13.1%
UGANDA	0 0%	0 0%	0 0%	0 0%	31 19.3%	11 28.2%	34 21.1%	8 20.5%	8 20.5%	0 0%	13 32.5%	1 10%	106 18.5%
UNITED STATES	40 100%	10 100%	20 100%	5 100%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	75 13.1%

Outcome Measures

1. Primary Outcome

Title	Part 1, Part 2 (Group 2): Number of Participants With Unsolicited Adverse Events
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV	Healthy (Part 1, Part 2; Group 2): Placebo	HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV	HIV-infected (Part 1, Part 2; Group 2): Placebo
Arm/Group Description	Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	Human immunodeficiency virus (HIV)- infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.
Measure Participants	79	20	60	15
Count of Participants [Participants]	33 82.5%	10 100%	32 160%	3 60%

2. Primary Outcome

Title	Part 2 (Group 1): Number of Participants With Unsolicited Adverse Events
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	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)
Arm/Group Description	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.	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.	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.	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.
Measure Participants	161	39	161	39
Count of Participants [Participants]	83 207.5%	21 210%	78 390%	15 300%

3. Primary Outcome

Title	Part 1, Part 2 (Group 2): Number of Participants With Serious Adverse Events (SAEs)
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV	Healthy (Part 1, Part 2; Group 2): Placebo	HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV	HIV-infected (Part 1, Part 2; Group 2): Placebo
Arm/Group Description	Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.
Measure Participants	79	20	60	15
Count of Participants [Participants]	1 2.5%	1 10%	3 15%	1 20%

4. Primary Outcome

Title	Part 2 (Group 1): Number of Participants With SAEs
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	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)
Arm/Group Description	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.	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.	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.	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.
Measure Participants	161	39	161	39
Count of Participants [Participants]	1 2.5%	1 10%	2 10%	0 0%

5. Primary Outcome

Title	Part 1, Part 2 (Group 2): Number of Participants With Immediate Reportable Events (IREs)
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: 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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV	Healthy (Part 1, Part 2; Group 2): Placebo	HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV	HIV-infected (Part 1, Part 2; Group 2): Placebo
Arm/Group Description	Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.
Measure Participants	79	20	60	15
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%

6. Primary Outcome

Title	Part 2 (Group 1): Number of Participants With IREs
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: 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)

Outcome Measure Data

Analysis Population Description

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/Group Title	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)
Arm/Group Description	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.	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.	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.	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.
Measure Participants	161	39	161	39
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%

7. Primary Outcome

Title	Parts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) 7 Days Post First Vaccination
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV	Healthy (Part 1, Part 2; Group 2): Placebo	HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV	HIV-infected (Part 1, Part 2; Group 2): Placebo	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)
Arm/Group Description	Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	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.	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.	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.	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.
Measure Participants	79	20	60	15	161	39	161	39
Count of Participants [Participants]	46 115%	5 50%	34 170%	3 60%	71 44.1%	10 25.6%	75 46.6%	7 17.9%

8. Primary Outcome

Title	Part 1, Part 2 (Group 2): Number of Participants With Solicited Local AEs 7 Days Post Second Vaccination
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV	Healthy (Part 1, Part 2; Group 2): Placebo	HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV	HIV-infected (Part 1, Part 2; Group 2): Placebo
Arm/Group Description	Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.
Measure Participants	78	20	58	14
Count of Participants [Participants]	44 110%	4 40%	33 165%	0 0%

9. Primary Outcome

Title	Part 2 (Group 1): Number of Participants With Solicited Local AEs 7 Days Post Second Vaccination
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	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)
Arm/Group Description	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.	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.	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.	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.
Measure Participants	159	37	160	38
Count of Participants [Participants]	82 205%	7 70%	64 320%	7 140%

10. Primary Outcome

Title	Parts 1 and 2: Number of Participants With Solicited Systemic Adverse Events 7 Days Post First Vaccination
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV	Healthy (Part 1, Part 2; Group 2): Placebo	HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV	HIV-infected (Part 1, Part 2; Group 2): Placebo	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)
Arm/Group Description	Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	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.	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.	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.	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.
Measure Participants	79	20	60	15	161	39	161	39
Count of Participants [Participants]	39 97.5%	10 100%	37 185%	7 140%	109 67.7%	24 61.5%	97 60.2%	18 46.2%

11. Primary Outcome

Title	Part 1, Part 2 (Group 2): Number of Participants With Solicited Systemic AEs 7 Days Post Second Vaccination
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV	Healthy (Part 1, Part 2; Group 2): Placebo	HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV	HIV-infected (Part 1, Part 2; Group 2): Placebo
Arm/Group Description	Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.
Measure Participants	78	20	58	14
Count of Participants [Participants]	45 112.5%	8 80%	35 175%	4 80%

12. Primary Outcome

Title	Part 2 (Group 1): Number of Participants With Solicited Systemic AEs 7 Days Post Second Vaccination
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	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)
Arm/Group Description	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.	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.	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.	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.
Measure Participants	159	37	160	38
Count of Participants [Participants]	83 207.5%	20 200%	80 400%	10 200%

13. Primary Outcome

Title	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)
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. 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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV	Healthy (Part 1, Part 2; Group 2): Placebo	HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV	HIV-infected (Part 1, Part 2; Group 2): Placebo
Arm/Group Description	Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.
Measure Participants	68	18	56	13
Geometric Mean (95% Confidence Interval) [EU/mL]	5733	40	2325	NA

14. Primary Outcome

Title	Part 2 (Group 1): GMCs of Binding Antibody Levels Against EBOV GP Measured Using FANG ELISA
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. 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)

Outcome Measure Data

Analysis Population Description

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/Group Title	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)
Arm/Group Description	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.	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.	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.	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.
Measure Participants	151	34	155	36
Geometric Mean (95% Confidence Interval) [EU/mL]	6037	NA	2939	NA

15. Secondary Outcome

Title	Number of Participants With Adverse Events
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV	HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants)	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants)
Arm/Group Description	Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo as prime vaccine on Day 1 followed by IM injection of single dose Ad26.ZEBOV as booster vaccine at Day 15.	HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo as prime vaccine on Day 1 followed by IM injection of single dose Ad26.ZEBOV as booster vaccine at Day 15.	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.	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.
Measure Participants	79	60	161	161
Unsolicited AEs	33 82.5%	32 320%	83 415%	78 1560%
Solicited Local AEs	56 140%	47 470%	103 515%	93 1860%
Solicited Systemic AEs	56 140%	46 460%	116 580%	117 2340%

Adverse Events

Time Frame	Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1)
Adverse Event Reporting Description	Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Arm/Group Title	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 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)		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)
Arm/Group Description	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.		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.		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.		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.		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.		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.		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.		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.		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.		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.		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.		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.
All Cause Mortality
	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 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)		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)
	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	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		0/161 (0%)		0/39 (0%)		0/161 (0%)		0/39 (0%)
Serious Adverse Events
	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 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)		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)
	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	Affected / at Risk (%)	# Events
Total	1/40 (2.5%)		1/10 (10%)		1/20 (5%)		1/5 (20%)		0/39 (0%)		0/10 (0%)		2/40 (5%)		0/10 (0%)		1/161 (0.6%)		1/39 (2.6%)		2/161 (1.2%)		0/39 (0%)
Blood and lymphatic system disorders
Anaemia	0/40 (0%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		0/161 (0%)		0/39 (0%)		1/161 (0.6%)		0/39 (0%)
Gastrointestinal disorders
Peptic Ulcer	0/40 (0%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		0/161 (0%)		0/39 (0%)		1/161 (0.6%)		0/39 (0%)
Immune system disorders
Anaphylactic Reaction	0/40 (0%)		1/10 (10%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		0/161 (0%)		0/39 (0%)		0/161 (0%)		0/39 (0%)
Infections and infestations
Appendicitis Perforated	0/40 (0%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		0/161 (0%)		1/39 (2.6%)		0/161 (0%)		0/39 (0%)
Malaria	0/40 (0%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		1/40 (2.5%)		0/10 (0%)		0/161 (0%)		0/39 (0%)		0/161 (0%)		0/39 (0%)
Postoperative Wound Infection	0/40 (0%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		0/161 (0%)		1/39 (2.6%)		0/161 (0%)		0/39 (0%)
Staphylococcal Osteomyelitis	0/40 (0%)		0/10 (0%)		0/20 (0%)		1/5 (20%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		0/161 (0%)		0/39 (0%)		0/161 (0%)		0/39 (0%)
Typhoid Fever	0/40 (0%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		1/40 (2.5%)		0/10 (0%)		0/161 (0%)		0/39 (0%)		0/161 (0%)		0/39 (0%)
Injury, poisoning and procedural complications
Soft Tissue Injury	0/40 (0%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		1/40 (2.5%)		0/10 (0%)		0/161 (0%)		0/39 (0%)		0/161 (0%)		0/39 (0%)
Wound	0/40 (0%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		1/40 (2.5%)		0/10 (0%)		0/161 (0%)		0/39 (0%)		0/161 (0%)		0/39 (0%)
Metabolism and nutrition disorders
Diabetes Mellitus	0/40 (0%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		1/161 (0.6%)		0/39 (0%)		0/161 (0%)		0/39 (0%)
Nervous system disorders
Cervical Cord Compression	0/40 (0%)		0/10 (0%)		0/20 (0%)		1/5 (20%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		0/161 (0%)		0/39 (0%)		0/161 (0%)		0/39 (0%)
Psychiatric disorders
Panic Attack	0/40 (0%)		0/10 (0%)		1/20 (5%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		0/161 (0%)		0/39 (0%)		0/161 (0%)		0/39 (0%)
Vascular disorders
Deep Vein Thrombosis	1/40 (2.5%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		0/161 (0%)		0/39 (0%)		0/161 (0%)		0/39 (0%)
Other (Not Including Serious) Adverse Events
	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 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)		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)
	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	Affected / at Risk (%)	# Events
Total	11/40 (27.5%)		5/10 (50%)		11/20 (55%)		0/5 (0%)		12/39 (30.8%)		5/10 (50%)		13/40 (32.5%)		3/10 (30%)		53/161 (32.9%)		15/39 (38.5%)		51/161 (31.7%)		11/39 (28.2%)
Blood and lymphatic system disorders
Anaemia	2/40 (5%)		0/10 (0%)		3/20 (15%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		2/161 (1.2%)		0/39 (0%)		3/161 (1.9%)		1/39 (2.6%)
Eosinophilia	0/40 (0%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		1/39 (2.6%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		3/161 (1.9%)		2/39 (5.1%)		0/161 (0%)		0/39 (0%)
Gastrointestinal disorders
Abdominal Pain	2/40 (5%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		1/40 (2.5%)		0/10 (0%)		3/161 (1.9%)		0/39 (0%)		2/161 (1.2%)		1/39 (2.6%)
Dental Caries	0/40 (0%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		1/10 (10%)		1/40 (2.5%)		0/10 (0%)		1/161 (0.6%)		0/39 (0%)		2/161 (1.2%)		0/39 (0%)
Diarrhoea	1/40 (2.5%)		0/10 (0%)		1/20 (5%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		2/40 (5%)		0/10 (0%)		0/161 (0%)		0/39 (0%)		3/161 (1.9%)		0/39 (0%)
Gastritis	0/40 (0%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		2/161 (1.2%)		0/39 (0%)		1/161 (0.6%)		4/39 (10.3%)
Nausea	0/40 (0%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		1/10 (10%)		0/40 (0%)		0/10 (0%)		0/161 (0%)		0/39 (0%)		1/161 (0.6%)		0/39 (0%)
Toothache	0/40 (0%)		0/10 (0%)		1/20 (5%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		0/161 (0%)		0/39 (0%)		0/161 (0%)		0/39 (0%)
General disorders
Fatigue	0/40 (0%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		2/40 (5%)		0/10 (0%)		1/161 (0.6%)		0/39 (0%)		1/161 (0.6%)		0/39 (0%)
Injection Site Erosion	0/40 (0%)		1/10 (10%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		0/161 (0%)		0/39 (0%)		0/161 (0%)		0/39 (0%)
Infections and infestations
Body Tinea	0/40 (0%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		1/10 (10%)		0/40 (0%)		0/10 (0%)		3/161 (1.9%)		0/39 (0%)		2/161 (1.2%)		0/39 (0%)
Gastroenteritis	0/40 (0%)		0/10 (0%)		1/20 (5%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		1/161 (0.6%)		0/39 (0%)		1/161 (0.6%)		1/39 (2.6%)
Influenza	0/40 (0%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		1/161 (0.6%)		3/39 (7.7%)		1/161 (0.6%)		0/39 (0%)
Malaria	0/40 (0%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		4/39 (10.3%)		2/10 (20%)		2/40 (5%)		0/10 (0%)		5/161 (3.1%)		1/39 (2.6%)		5/161 (3.1%)		1/39 (2.6%)
Otitis Media	0/40 (0%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		1/10 (10%)		0/40 (0%)		0/10 (0%)		1/161 (0.6%)		0/39 (0%)		2/161 (1.2%)		0/39 (0%)
Pharyngitis	0/40 (0%)		0/10 (0%)		2/20 (10%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		1/161 (0.6%)		0/39 (0%)		4/161 (2.5%)		0/39 (0%)
Rash Pustular	0/40 (0%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		1/10 (10%)		0/40 (0%)		0/10 (0%)		0/161 (0%)		0/39 (0%)		0/161 (0%)		0/39 (0%)
Rhinitis	0/40 (0%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		2/39 (5.1%)		0/10 (0%)		1/40 (2.5%)		1/10 (10%)		2/161 (1.2%)		1/39 (2.6%)		3/161 (1.9%)		0/39 (0%)
Upper Respiratory Tract Infection	2/40 (5%)		0/10 (0%)		1/20 (5%)		0/5 (0%)		5/39 (12.8%)		3/10 (30%)		3/40 (7.5%)		3/10 (30%)		23/161 (14.3%)		4/39 (10.3%)		25/161 (15.5%)		5/39 (12.8%)
Injury, poisoning and procedural complications
Apheresis Related Complication	3/40 (7.5%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		0/161 (0%)		0/39 (0%)		0/161 (0%)		0/39 (0%)
Meniscus Injury	0/40 (0%)		0/10 (0%)		1/20 (5%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		0/161 (0%)		0/39 (0%)		0/161 (0%)		0/39 (0%)
Muscle Strain	0/40 (0%)		1/10 (10%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		0/161 (0%)		0/39 (0%)		0/161 (0%)		0/39 (0%)
Procedural Pain	0/40 (0%)		0/10 (0%)		1/20 (5%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		0/161 (0%)		0/39 (0%)		0/161 (0%)		0/39 (0%)
Soft Tissue Injury	0/40 (0%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		1/10 (10%)		0/40 (0%)		1/10 (10%)		2/161 (1.2%)		0/39 (0%)		0/161 (0%)		0/39 (0%)
Investigations
Alanine Aminotransferase Increased	0/40 (0%)		0/10 (0%)		1/20 (5%)		0/5 (0%)		1/39 (2.6%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		3/161 (1.9%)		0/39 (0%)		1/161 (0.6%)		0/39 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/40 (0%)		1/10 (10%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		1/161 (0.6%)		1/39 (2.6%)		1/161 (0.6%)		0/39 (0%)
Back Pain	0/40 (0%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		1/39 (2.6%)		0/10 (0%)		2/40 (5%)		0/10 (0%)		2/161 (1.2%)		3/39 (7.7%)		4/161 (2.5%)		1/39 (2.6%)
Musculoskeletal Chest Pain	2/40 (5%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		1/161 (0.6%)		0/39 (0%)		0/161 (0%)		0/39 (0%)
Nervous system disorders
Dizziness	0/40 (0%)		0/10 (0%)		1/20 (5%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		2/161 (1.2%)		0/39 (0%)		0/161 (0%)		0/39 (0%)
Headache	0/40 (0%)		0/10 (0%)		1/20 (5%)		0/5 (0%)		0/39 (0%)		1/10 (10%)		4/40 (10%)		0/10 (0%)		9/161 (5.6%)		3/39 (7.7%)		9/161 (5.6%)		1/39 (2.6%)
Paraesthesia	0/40 (0%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		0/161 (0%)		2/39 (5.1%)		0/161 (0%)		0/39 (0%)
Presyncope	1/40 (2.5%)		0/10 (0%)		1/20 (5%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		0/161 (0%)		0/39 (0%)		0/161 (0%)		0/39 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	0/40 (0%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		2/39 (5.1%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		2/161 (1.2%)		0/39 (0%)		1/161 (0.6%)		0/39 (0%)
Oropharyngeal Pain	0/40 (0%)		1/10 (10%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		0/40 (0%)		0/10 (0%)		1/161 (0.6%)		0/39 (0%)		1/161 (0.6%)		0/39 (0%)
Rhinitis Allergic	0/40 (0%)		0/10 (0%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		1/10 (10%)		0/40 (0%)		0/10 (0%)		0/161 (0%)		0/39 (0%)		1/161 (0.6%)		0/39 (0%)
Vascular disorders
Hypertension	1/40 (2.5%)		2/10 (20%)		0/20 (0%)		0/5 (0%)		0/39 (0%)		0/10 (0%)		1/40 (2.5%)		0/10 (0%)		1/161 (0.6%)		0/39 (0%)		0/161 (0%)		0/39 (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.