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Ad26.ZEBOV

Phase 3

Ebola Virus Disease | Monoclonal antibody | Infectious Disease |Johnson & Johnson|Last Updated: May 25, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment1,830
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02509494Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-FiloPHASE3 COMPLETED 1,023Sep 30, 2015Jul 3, 2019Jul 18, 20221 Sierra Leone
NCT04186000Study to Evaluate the Immunogenicity and Safety of a Heterologous Vaccine Regimen Against EbolaPHASE2 COMPLETED 699Dec 18, 2019Oct 12, 2022Jan 4, 20231 Democratic Republic of the Congo
NCT03929757A Study of 2-dose Vaccination Regimen of Ad26.ZEBOV and MVA-BN-Filo in InfantsPHASE2 COMPLETED 108Aug 19, 2019Sep 28, 2022May 25, 20252 Guinea, Sierra Leone
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Study Endpoints
Primary Endpoints
Stages 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) (Day 8)
7 days post dose 1 (Day 8)

Number of participants with solicited local AEs were reported. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.

Stages 1 and 2: Number of Participants With Solicited Local AEs (Day 64)
7 days post dose 2 (Day 64)

Number of participants with solicited local AEs were reported. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.

Stage 1: Number of Participants With Solicited Local AEs (Day 738)
7 days post dose 3 (Day 738)

Number of participants with solicited local AEs were reported. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.

Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 8)
7 days post dose 1 (Day 8)

Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included body temperature, vomiting, reduced activity, somnolence, fatigue, irritability/fussiness/crying/screaming, and loss of appetite (for preverbal children/infants) and body temperature, nausea/vomiting, fatigue/malaise, muscle pain, chills, joint pain and headache (for young children, adolescents, and adults).

Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 64)
7 days post dose 2 (Day 64)

Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included body temperature, vomiting, reduced activity, somnolence, fatigue, irritability/fussiness/crying/screaming, and loss of appetite (for preverbal children/infants) and body temperature, nausea/vomiting, fatigue/malaise, muscle pain, chills, joint pain and headache (for young children, adolescents, and adults).

Stage 1: Number of Participants With Solicited Systemic AEs (Day 738)
7 days post dose 3 (Up to Day 738)

Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included body temperature, vomiting, reduced activity, somnolence, fatigue, irritability/fussiness/crying/screaming, and loss of appetite (for preverbal children/infants) and body temperature, nausea/vomiting, fatigue/malaise, muscle pain, chills, joint pain and headache (for young children, adolescents, and adults).

Stages 1: Number of Participants With Serious Adverse Events (SAEs)
Up to 36 months

Number of Participants with SAEs were reported. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.

Stages 2: Number of Participants With SAEs
Up to 24 months

Number of Participants with SAEs were reported. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.

Stage 1: Number of Participants With Unsolicited AEs (Day 759)
28 days post booster dose (Day 759)

Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Stage 1: Number of Participants With Unsolicited AEs (Day 29)
28 days post dose 1 (Day 29)

Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Stage 2: Number of Participants With Unsolicited AEs (Day 29)
28 days post dose 1 (Day 29)

Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Stage 1: Number of Participants With Unsolicited AEs (Day 85)
28 days post dose 2 (Day 85)

Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Stage 2: Number of Participants With Unsolicited AEs (Day 85)
28 days post dose 2 (Day 85)

Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Stage 1: Number of Participants With Deaths
Up to 36 months

Number of participants with deaths were reported.

Stage 2: Number of Participants With Deaths (Children and Adolescents)
Up to 12 months

Number of participants (children and adolescents) with deaths were reported.

Stage 2: Number of Participants With Deaths (Adults)
Up to 24 months

Number of participants (adults) with deaths were reported.

Stage 1: Number of Participants With Immediate Reportable Event (IREs)
Up to 36 months

Number of participants with IREs were reported. The following list of neuroinflammatory disorders are categorized as IREs: Cranial nerve disorders, including paralyses/paresis, optic neuritis, multiple sclerosis, transverse myelitis, guillain-Barré syndrome, acute disseminated encephalomyelitis, including site specific variants, myasthenia gravis and Lambert-Eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, narcolepsy, isolated paresthesia of greater than (\>) 7 days duration.

Stage 2: Number of Participants With IREs (Children and Adolescents)
Up to 12 months

Number of participants (children and adolescents) with IREs were reported. The following list of neuroinflammatory disorders are categorized as IREs: Cranial nerve disorders, including paralyses/paresis, optic neuritis, multiple sclerosis, transverse myelitis, guillain-Barré syndrome, acute disseminated encephalomyelitis, including site specific variants, myasthenia gravis and Lambert-Eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, narcolepsy, isolated paresthesia of greater than (\>) 7 days duration.

Stage 2: Number of Participants With IREs (Adults)
Up to 24 months

Number of participants (adults) with IREs were reported. The following list of neuroinflammatory disorders are categorized as IREs: Cranial nerve disorders, including paralyses/paresis, optic neuritis, multiple sclerosis, transverse myelitis, guillain-Barré syndrome, acute disseminated encephalomyelitis, including site specific variants, myasthenia gravis and Lambert-Eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, narcolepsy, isolated paresthesia of greater than (\>) 7 days duration.

Binding antibody responses post-dose 2 vaccination with MVA-BN-Filo
21 days post-dose 2 vaccination

To assess binding antibody levels against the EBOV GP using FANG ELISA

Main Study: Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) up to 7 Days Post-dose 1
From dose 1 (Day 1) up to 7 days post-dose 1 (Day 8)

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. Solicited local AEs that included injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site, were pre-defined local (at the injection site) AEs for which participant were specifically questioned and which were noted by participant in their diary for 7 days post vaccination. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.

Main Study: Percentage of Participants With Solicited Local and Systemic AEs up to 7 Days Post-dose 2
From dose 2 (Day 57) up to 7 days post-dose 2 (Day 64)

An AE is any untoward medical occurrence in a participants participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site, were pre-defined local (at the injection site) AEs for which participant were specifically questioned and which were noted by participant in their diary for 7 days post vaccination. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.

Main Study: Percentage of Participants With Unsolicited AEs up to 28 Days Post-dose 1
From dose 1 (Day 1) up to 28 days post-dose 1 (Day 29)

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 AEs were events which were reported by the participant voluntarily or obtained by means of interviewing the participants in a nondirected manner.

Main Study: Percentage of Participants With Unsolicited AEs up to 28 Days Post-dose 2
From dose 2 (Day 57) up to 28 days post-dose 2 (Day 85)

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 AEs were events which were reported by the participant voluntarily or obtained by means of interviewing the participant in a nondirected manner.

Main Study: Percentage of Participants With Serious Adverse Events (SAEs) up to 6 Months Post Dose-2 on Day 57
Up to 6 months post dose-2 on Day 57 (Up to 8 months)

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. 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.

Main Study: Percentage of Participants With SAEs Related to Study Intervention
Up to Day 365

Percentage of participants with SAEs related to study intervention were reported. 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.

Secondary Endpoints
Stages 1 and 2: Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Enzyme-linked Immunosorbent Assay (ELISA)
21 days post-dose 2 (Day 78)
Safety of a heterologous vaccine regimen utilizing Ad26.ZEBOV as dose 1, MVA-BN-Filo as dose 2 and Ad26.ZEBOV as booster dose 3
The entire clinical study for SAE reporting and until 7 days post booster for solicited local and system adverse events
Binding antibody responses after booster vaccination with Ad26.ZEBOV
7 days post-booster vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Stage 1: Active vaccinationEXPERIMENTALAd26.ZEBOV will be administered as a 0.5 milliliter (mL) intramuscular (IM) injection (Dose 1); MVA-BN-Filo will be administered as a 0.5 mL IM injection (Dose 2). The booster vaccination using Ad26.ZEBOV will be administered as a 0.5 mL IM injection (2 years post Dose 1).
Stage 2: Active vaccinationEXPERIMENTALAd26.ZEBOV will be administered as a 0.5 mL IM injection (Dose 1); MVA-BN-Filo will be administered as a 0.5 mL IM injection (Dose 2).
Stage 2: Active vaccination for childrenEXPERIMENTALAd26.ZEBOV will be administered as a 0.5 mL IM injection (Dose 1); MVA-BN-Filo will be administered as a 0.5 mL IM injection (Dose 2). Children aged less than 2 years at randomization will receive a booster dose of vaccination at 3 months post Dose 2 with Placebo.
Stage 2: Control vaccinationACTIVE_COMPARATORMenACWY will be administered as a 0.5 mL IM injection on Day 1 (Dose 1) and placebo on Day 57 (Dose 2).
Stage 2: Control vaccination for childrenACTIVE_COMPARATORMenACWY will be administered as a 0.5 mL IM injection on Day 1 (Dose 1) and placebo on Day 57 (Dose 2). Children aged less than 2 years at randomization will receive a booster dose of MenACWY vaccination at 3 months post Dose 2 with MenACWY.
group 1EXPERIMENTALBooster vaccine with AD26.ZEBOV after 1 year
group 2EXPERIMENTALBooster vaccine with AD26.ZEBOV after 2 years
Arm 1: Ad26.ZEBOV, MVA-BN-FiloEXPERIMENTALParticipants will be administered 0.5 mL of Ad26.ZEBOV vaccine (5\*10\^10 viral particles \[vp\]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of MVA-BN-Filo (1\*10\^8 infectious units \[Inf U\]) vaccine by IM injection on Day 57. Participants will also receive a dose of MenACWY at the 6-months post-dose-2 visit. Upon completion of the main study, participants in the extension phase who were originally randomized to the control arm will receive the same vaccine regimen as the participants in the Ad26.ZEBOV, MVA-BN-Filo arm of the main study.
Arm 2: MenACWYACTIVE_COMPARATORParticipants will be administered 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Participants will also receive a dose of MenACWY at the 6-months post-dose-2 visit.
Interventions
NameTypeDescription
Ad26.ZEBOVBIOLOGICALEbola Zaire vaccine, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5\*10\^10 viral particles.
MVA-BN-FiloBIOLOGICALMVA-BN-Filo- is a non-replicating vaccine, 0.5 mL IM injection of 1\*10\^8 Infectious Unit (Inf. U.).
MenACWYBIOLOGICALMenACWY is a WHO-prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine.
PlaceboBIOLOGICAL0.9% saline for injection.
Ad26.ZEBOV vaccineBIOLOGICALThe booster vaccination with Ad26.ZEBOV (5x10\^10 vp, same dosage as during the first dose) will be given at 1 year after the first dose or 2 years post-first dose.
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Eligibility Criteria
Age Range1 Year — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria Stage 1 and 2: * Documented community engagement from community leader and a signed inform consent form (ICF) from each participant must be available * Participant Stage 1 must be 18 years or older at screening and be resident in selected study community with no intention to move...

Countries:Sierra LeoneDemocratic Republic of the CongoGuinea
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