Ebola Viral DiseasePhase 2NCT02416453

A Study to Assess Safety, Tolerability, and Immunogenicity of Three Heterologus 2-dose Regimens of the Candidate Prophylactic Vaccines for Ebola in Healthy Adults

A Phase 2 study testing MVA-BN-Filo and Ad26.ZEBOV in people with Ebola Viral Disease, run by Janssen Vaccines & Prevention B.V. at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Ebola Viral Disease
What is being tested?: MVA-BN-Filo and Ad26.ZEBOV
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 423 participants
Where: 11 sitesin 2 countries
Study dates: 15 Jun 2015to 19 Jan 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

11 sites in 2 countries.

Country

City, postcode or hospital

11 sites in 2 countries

France8 sites

Study site
Créteil
Study site
Marseille
Study site
Paris
Study site
Pierre-Bénite
Study site
Rennes
Study site
Saint-Etienne
Study site
Strasbourg
Study site
Tours

Other trials in France

United Kingdom3 sites

Study site
London
Study site
Oxford
Study site
Southampton

Other trials in United Kingdom

About this study

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

Read the 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.

Conditions: Ebola Viral Disease
Being tested: MVA-BN-Filo, Ad26.ZEBOV, Placebo
Keywords: Healthy, Ebola viruses, Ebola Viral Disease (EVD), Filoviruses, Monovalent vaccine, Human adenovirus serotype 26 (Ad26) encoding the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV), Modified Vaccinia Virus Ankara - Bavarian Nordic Filo-vector (MVA-BN Filo), Safety, Immunogenicity, Inserm and University of Oxford

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MVA-BN-FiloBiological
One 0.5 mL intramuscular (IM) injection of 1E8 Infectious Unit [Inf. U.] on Day 29, 57, or 85.
Ad26.ZEBOVBiological
One 0.5 mL IM injection of 5E10 viral particles (vp) on Day 1.
PlaceboBiological
One 0.5 mL IM injection of 0.9% saline on Day 1 and Day 29, 57, or 85.

Study groups in NCT02416453
Study group	Role	What they receive
Group 1	Experimental	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. Receives: Biological: MVA-BN-Filo; Biological: Ad26.ZEBOV; Biological: Placebo
Group 2	Experimental	Participants will receive IM injection of Ad26.ZEBOV/Placebo on Day 1 followed by IM injection of MVA-BN-Filo/Placebo on Day 57. Receives: Biological: MVA-BN-Filo; Biological: Ad26.ZEBOV; Biological: Placebo
Group 3	Experimental	Participants will receive IM injection of Ad26.ZEBOV/Placebo on Day 1 followed by IM injection of MVA-BN-Filo/Placebo on Day 85. Receives: Biological: MVA-BN-Filo; Biological: Ad26.ZEBOV; Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Unsolicited Adverse Events (Groups 1, 2 and 3)
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.
Measured: Up to 42-day post dose 2 visit (Day 1 to Day 127)
Number of Participants With Serious Adverse Events (Groups 1, 2 and 3)
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Up to Day 365
Number of Participants With Immediate Reportable Events (Groups 1, 2 and 3)
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.
Measured: Up to Day 365
Number of Participants With Solicited Local Adverse Events (Groups 1, 2 and 3)
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.
Measured: 7 days post-dose 1 (Day 8)
Number of Participants With Solicited Local Adverse Events (Groups 1, 2 and 3)
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.
Measured: 7 days post-dose 2 (Up to Day 92)
Number of Participants With Solicited Systemic Adverse Events (Groups 1, 2 and 3)
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.
Measured: 7 days post-dose 1 (Day 8)
Number of Participants With Solicited Systemic Adverse Events (Groups 1, 2 and 3)
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.
Measured: 7 days post-dose 2 (Up to Day 92)

Secondary outcomes (6)

Number of Participants With Unsolicited Adverse Events (Group 4)
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.
Measured: Up to 28-day post dose 1 (Day 29)
Number of Participants With Serious Adverse Events (Group 4)
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.
Measured: Up to Day 180
Number of Participants With Immediate Reportable Events (Group 4)
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.
Measured: Up to Day 180
Number of Participants With Solicited Local Adverse Events (Group 4)
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.
Measured: 7 days after each vaccination (Up to Day 8)
Number of Participants With Solicited Systemic Adverse Events (Group 4)
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.
Measured: 7 days after each vaccination (Up to Day 8)
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)
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.
Measured: At 21-days post dose 2 (Day 50 for Group 1; Day 78 for Group 2; and Day 106 for Group 3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 201519 Jan 2018

First posted15 Apr 2015 (estimated)
Study start15 Jun 2015
Primary completion19 Jan 2018
Study completion19 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Ebola Viral DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 423 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02416453
Sponsor's protocol ID: CR107227
Other IDs: VAC52150EBL2001, 2015-000596-27, 2015
Status last verified: Jan 2021
First submitted: 10 Apr 2015
Last updated: 8 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Lacabaratz C, Durand M, Wiedemann A, Foucat E, Surenaud M, Krief C, Guillaumat L, Robinson C, Luhn K, Bockstal V, Thiebaut R, Richert L, Levy Y. Innate and Cellular Immune Response to the Ebola Vaccine Ad26.ZEBOV, MVA-BN-Filo: An Ancillary Study of the EBL2001 Phase 2 Trial. J Infect Dis. 2025 Feb 4;231(1):230-240. doi: 10.1093/infdis/jiae360.
PubMed 39012798
Barry H, Lhomme E, Surenaud M, Nouctara M, Robinson C, Bockstal V, Valea I, Somda S, Tinto H, Meda N, Greenwood B, Thiebaut R, Lacabaratz C. Helminth exposure and immune response to the two-dose heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen. PLoS Negl Trop Dis. 2024 Apr 11;18(4):e0011500. doi: 10.1371/journal.pntd.0011500. eCollection 2024 Apr.
PubMed 38603720
Pollard AJ, Launay O, Lelievre JD, Lacabaratz C, Grande S, Goldstein N, Robinson C, Gaddah A, Bockstal V, Wiedemann A, Leyssen M, Luhn K, Richert L, Betard C, Gibani MM, Clutterbuck EA, Snape MD, Levy Y, Douoguih M, Thiebaut R; EBOVAC2 EBL2001 study group. Safety and immunogenicity of a two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Europe (EBOVAC2): a randomised, observer-blind, participant-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2021 Apr;21(4):493-506. doi: 10.1016/S1473-3099(20)30476-X. Epub 2020 Nov 17.
PubMed 33217361

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02416453
Acronym / sponsor ID: CR107227
Conditions: Ebola Viral Disease
Keywords: Healthy, Ebola viruses, Ebola Viral Disease (EVD), Filoviruses, Monovalent vaccine, Human adenovirus serotype 26 (Ad26) encoding the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV), Modified Vaccinia Virus Ankara - Bavarian Nordic Filo-vector (MVA-BN Filo), Safety
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 423 participants (actual)
Lead sponsor: Janssen Vaccines & Prevention B.V.Industry (pharma, biotech, devices)
Collaborators: Institut National de la Santé Et de la Recherche Médicale, France, University of Oxford
Study start: 15 Jun 2015 (actual)
Primary completion: 19 Jan 2018 (actual)
Study completion: 19 Jan 2018 (actual)
First posted: 15 Apr 2015 (estimated)
Results: Posted 8 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Group 1	Experimental	Biological: MVA-BN-Filo, Biological: Ad26.ZEBOV, Biological: PlaceboParticipants will receive intramuscular (IM) injection of Ad26.ZEBOV/Placebo on Day 1 followed by IM injection of MVA-BN-Filo/Placebo on Day 29.
Group 2	Experimental	Biological: MVA-BN-Filo, Biological: Ad26.ZEBOV, Biological: PlaceboParticipants will receive IM injection of Ad26.ZEBOV/Placebo on Day 1 followed by IM injection of MVA-BN-Filo/Placebo on Day 57.
Group 3	Experimental	Biological: MVA-BN-Filo, Biological: Ad26.ZEBOV, Biological: PlaceboParticipants will receive IM injection of Ad26.ZEBOV/Placebo on Day 1 followed by IM injection of MVA-BN-Filo/Placebo on Day 85.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MVA-BN-FiloOne 0.5 mL intramuscular (IM) injection of 1E8 Infectious Unit [Inf. U.] on Day 29, 57, or 85.	Biological	Group 1, Group 2, Group 3
Ad26.ZEBOVOne 0.5 mL IM injection of 5E10 viral particles (vp) on Day 1.	Biological	Group 1, Group 2, Group 3
PlaceboOne 0.5 mL IM injection of 0.9% saline on Day 1 and Day 29, 57, or 85.	Biological	Group 1, Group 2, Group 3

Primary outcome

Number of Participants With Unsolicited Adverse Events (Groups 1, 2 and 3)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.

6 secondary outcomes

Number of Participants With Unsolicited Adverse Events (Group 4)
Time frame: Up to 28-day post dose 1 (Day 29)
Number of Participants With Serious Adverse Events (Group 4)
Time frame: Up to Day 180
Number of Participants With Immediate Reportable Events (Group 4)
Time frame: Up to Day 180
Number of Participants With Solicited Local Adverse Events (Group 4)
Time frame: 7 days after each vaccination (Up to Day 8)
Number of Participants With Solicited Systemic Adverse Events (Group 4)
Time frame: 7 days after each vaccination (Up to Day 8)
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)
Time frame: At 21-days post dose 2 (Day 50 for Group 1; Day 78 for Group 2; and Day 106 for Group 3)

Results and safety

Results posted to the registry on 8 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)	10	7
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)	10	7
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)	10	9
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)	112	97
Group 1: Pooled Cohorts II and III: Placebo	13	12
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)	114	98
Group 2: Pooled Cohorts II and III: Placebo	13	11
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)	106	94
Group 3: Pooled Cohorts II and III: Placebo	18	13
Group 4: Ad26.ZEBOV	13	13
Group 4: Placebo	2	2

Primary outcome: Number of Participants With Unsolicited Adverse Events (Groups 1, 2 and 3)

Time frame: Up to 42-day post dose 2 visit (Day 1 to Day 127). Count of participants. Unit: Participants

Measure	Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) n = 10	Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) n = 10	Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval) n = 10	Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) n = 112	Group 1: Pooled Cohorts II and III: Placebo n = 13	Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) n = 114	Group 2: Pooled Cohorts II and III: Placebo n = 13	Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval) n = 106	Group 3: Pooled Cohorts II and III: Placebo n = 18
Value	4	6	6	62	6	52	7	46	8

Population analysed: 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.

Primary outcome: Number of Participants With Serious Adverse Events (Groups 1, 2 and 3)

Time frame: Up to Day 365. Count of participants. Unit: Participants

Measure	Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) n = 10	Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) n = 10	Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval) n = 10	Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) n = 112	Group 1: Pooled Cohorts II and III: Placebo n = 13	Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) n = 114	Group 2: Pooled Cohorts II and III: Placebo n = 13	Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval) n = 106	Group 3: Pooled Cohorts II and III: Placebo n = 18
Value	0	1	0	2	0	4	1	5	1

Primary outcome: Number of Participants With Immediate Reportable Events (Groups 1, 2 and 3)

Time frame: Up to Day 365. Count of participants. Unit: Participants

Measure	Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) n = 10	Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) n = 10	Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval) n = 10	Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) n = 112	Group 1: Pooled Cohorts II and III: Placebo n = 13	Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) n = 114	Group 2: Pooled Cohorts II and III: Placebo n = 13	Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval) n = 106	Group 3: Pooled Cohorts II and III: Placebo n = 18
Value	0	0	0	0	0	2	0	2	0

Primary outcome: Number of Participants With Solicited Local Adverse Events (Groups 1, 2 and 3)

Time frame: 7 days post-dose 1 (Day 8). Count of participants. Unit: Participants

Measure	Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) n = 10	Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) n = 10	Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval) n = 10	Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval) n = 112	Group 1: Pooled Cohorts II and III: Placebo n = 13	Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval) n = 114	Group 2: Pooled Cohorts II and III: Placebo n = 13	Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval) n = 106	Group 3: Pooled Cohorts II and III: Placebo n = 18
Value	8	6	8	63	3	65	2	78	4

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Day 365. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)	0 of 10 (0%)	4 of 10 (40%)	0 of 10
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)	1 of 10 (10%)	5 of 10 (50%)	0 of 10
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)	0 of 10 (0%)	6 of 10 (60%)	0 of 10
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)	2 of 112 (1.8%)	41 of 112 (36.6%)	0 of 112
Group 1: Pooled Cohorts II and III: Placebo	0 of 13 (0%)	6 of 13 (46.2%)	0 of 13
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)	4 of 114 (3.5%)	30 of 114 (26.3%)	0 of 114
Group 2: Pooled Cohorts II and III: Placebo	1 of 13 (7.7%)	7 of 13 (53.8%)	0 of 13
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)	5 of 106 (4.7%)	26 of 106 (24.5%)	0 of 106
Group 3: Pooled Cohorts II and III: Placebo	1 of 18 (5.6%)	8 of 18 (44.4%)	0 of 18
Group 4: Ad26.ZEBOV	2 of 13 (15.4%)	6 of 13 (46.2%)	0 of 13
Group 4: Placebo	0 of 2 (0%)	1 of 2 (50%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39012798Lacabaratz C, Durand M, Wiedemann A, Foucat E, Surenaud M, Krief C, Guillaumat L, Robinson C, Luhn K, Bockstal V, Thiebaut R, Richert L, Levy Y. Innate and Cellular Immune Response to the Ebola Vaccine Ad26.ZEBOV, MVA-BN-Filo: An Ancillary Study of the EBL2001 Phase 2 Trial. J Infect Dis. 2025 Feb 4;231(1):230-240. doi: 10.1093/infdis/jiae360.
Derived from this study: PubMed 38603720Barry H, Lhomme E, Surenaud M, Nouctara M, Robinson C, Bockstal V, Valea I, Somda S, Tinto H, Meda N, Greenwood B, Thiebaut R, Lacabaratz C. Helminth exposure and immune response to the two-dose heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen. PLoS Negl Trop Dis. 2024 Apr 11;18(4):e0011500. doi: 10.1371/journal.pntd.0011500. eCollection 2024 Apr.
Derived from this study: PubMed 33217361Pollard AJ, Launay O, Lelievre JD, Lacabaratz C, Grande S, Goldstein N, Robinson C, Gaddah A, Bockstal V, Wiedemann A, Leyssen M, Luhn K, Richert L, Betard C, Gibani MM, Clutterbuck EA, Snape MD, Levy Y, Douoguih M, Thiebaut R; EBOVAC2 EBL2001 study group. Safety and immunogenicity of a two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Europe (EBOVAC2): a randomised, observer-blind, participant-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2021 Apr;21(4):493-506. doi: 10.1016/S1473-3099(20)30476-X. Epub 2020 Nov 17.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen Vaccines & Prevention B.V. Clinical Trial study director

Janssen Vaccines & Prevention B.V.

Inserm Clinical Trials study director

Institut National de la Santé Et de la Recherche Médicale, France

11 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MVA-BN-Filo and Ad26.ZEBOV in people with Ebola Viral Disease, run by Janssen Vaccines & Prevention B.V. at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Unsolicited Adverse Events (Groups 1, 2 and 3) (time frame: Up to 42-day post dose 2 visit (Day 1 to Day 127)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02416453, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.