Ebola Virus DiseasePhase 3EBOVAC-SaloneNCT02509494

Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo

A Phase 3 study testing Ad26.ZEBOV, MVA-BN-Filo and MenACWY in people with Ebola Virus Disease, run by Janssen Vaccines & Prevention B.V. at 1 site in Sierra Leone.

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 the evaluation of the safety and immunogenicity of two candidate Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo, in a 2-dose heterologous regimen. Read more about this study

Who is it for?: Ages 1 year and olderHealthy volunteers can take part
Conditions the study is for: Ebola Virus Disease
What is being tested?: Ad26.ZEBOV, MVA-BN-Filo and MenACWY
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,023 participants
Where: 1 siteSierra Leone
Study dates: 30 Sep 2015to 3 Jul 2019
Phase: Phase 3
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 1 year and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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 from study area within the next 5 months
Participant must be healthy with no abnormalities in laboratory screening tests within 28 days before Dose 1 vaccination
Female participants of childbearing potential must use adequate birth control measures and must have a negative pregnancy test at screening and immediately prior to each study vaccination
Participant must pass the test of understanding (TOU)
Additional Inclusion criteria Stage 2:

Show all 9Show fewer

One year or older at screening (children of enrolled parents are eligible)
Parent/legal guardian (for children) must pass the TOU before signing the ICF
Subjects aged 7 years and older will be asked to give positive assent in the presence of a witness

Who cannot join

Diagnosed with EVD or under quarantine/exposed to Ebola or body temperature equal of >= 38 degree Celsius (fever)
Having an acute illness (mild in nature that can be treated at home) or any clinically significant acute/chronic medical condition or having a decreased number of red blood cells/hemoglobin in the blood (anemia)
Previously participated in another Ebola interventional study or received any Ad26/MVA-based candidate vaccine
Vaccinated with live attenuated vaccines within 30 days or with inactivated vaccines 15 days before Dose 1 vaccination
Treated with an immunosuppressive drug at the time of screening
Additional exclusion criteria:
Children up to 5 years of age with severe malnutrition (underweight or Z-score weight <2)

Trial locations and contacts

1 site in 1 country.

Sierra Leone1 site

Study site
Freetown

Other trials in Sierra Leone

About this study

Official title: A Staged Phase 3 Study, Including a Double-Blinded Controlled Stage to Evaluate the Safety and Immunogenicity of Ad26.ZEBOV and MVA-BN-Filo as Candidate Prophylactic Vaccines for Ebola

The purpose of this study is the evaluation of the safety and immunogenicity of two candidate Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo, in a 2-dose heterologous regimen.

Read the detailed description

This is staged Phase 3 study to gather information on the safety and immunogenicity of a 2-dose heterologous regimen. In this regimen, Ad26.ZEBOV will be administered as a Dose 1 vaccination followed by the candidate vaccine MVA-BN-Filo (Dose 2 56 days later) and a booster dose of A26.ZEBOV will be administered 2 years post Dose 1 vaccination to participants in Stage 1 who consent to this. The study will take place in Sierra Leone and will consist of a screening phase, an active phase (vaccination) and a follow-up phase. The active phase of the study will be conducted initially in two stages. In the first stage approximately 40 adults aged 18 years or older will be vaccinated to gain information about the safety and immunogenicity of the 2-dose heterologous vaccine regimen. In stage 2 a larger group of approximately 976 individuals will be vaccinated to further evaluate the safety and immunogenicity of the 2 dose heterologous vaccine regimen across different age groups. In this stage, children aged 1 year or older, adolescents and adults will be included. Solicited local and systemic adverse events will be collected until 7 days after the Dose 1 and Dose 2 vaccination. Unsolicited adverse events will be collected from signing of the informed consent form (ICF) onwards until 56 days after the Dose 2 vaccination in Stage 1 and then again from the day of the booster vaccination until 28 days after the booster vaccination, and until 28 days after each vaccination in stage 2. Serious adverse events will be collected from signing of the ICF onwards until 12 and 36 months after the Dose 1 vaccination in Stage 2 and Stage 1, respectively. These data will be reviewed by an independent data monitoring committee (IDMC) to assess whether initiation of vaccination in the next stage or age group can be provided. Safety evaluations will include assessment of adverse events, which will be monitored throughout the study. Participants in Stage 2 will be followed up for safety and immunogenicity until 12 months (children and adolescents) or 24 months (adults) after the Dose 1 vaccination. Participants in Stage 1 will be followed up for safety and immunogenicity until 36 months after the Dose 1 vaccination or until 1 year after the booster vaccination.

Conditions: Ebola Virus Disease
Being tested: Ad26.ZEBOV, MVA-BN-Filo, MenACWY, Placebo
Keywords: Vaccine, Ebola, Ebola virus disease, EVD, Hemorrhagic fever, Sierra Leone, Human adenovirus serotype 26 (Ad26) encoding the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV), Safety, Immunogenicity, Modified Vaccinia Virus Ankara - Bavarian Nordic Filo-vector, (MVA-BN Filo)
Medical subject headings: Hemorrhagic Fever, Ebola, Hemorrhagic Fevers, Viral

What participants receive

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

Ad26.ZEBOVBiological
Ebola Zaire vaccine, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5*10^10 viral particles.
MVA-BN-FiloBiological
MVA-BN-Filo- is a non-replicating vaccine, 0.5 mL IM injection of 1*10^8 Infectious Unit (Inf. U.).
MenACWYBiological
MenACWY is a WHO-prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine.
PlaceboBiological
0.9% saline for injection.

Study groups in NCT02509494
Study group	Role	What they receive
Stage 1: Active vaccination	Experimental	Ad26.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). Receives: Biological: Ad26.ZEBOV; Biological: MVA-BN-Filo
Stage 2: Active vaccination	Experimental	Ad26.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). Receives: Biological: Ad26.ZEBOV; Biological: MVA-BN-Filo
Stage 2: Active vaccination for children	Experimental	Ad26.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. Receives: Biological: Ad26.ZEBOV; Biological: MVA-BN-Filo
Stage 2: Control vaccination	Active comparator	MenACWY will be administered as a 0.5 mL IM injection on Day 1 (Dose 1) and placebo on Day 57 (Dose 2). Receives: Biological: MenACWY; Biological: Placebo
Stage 2: Control vaccination for children	Active comparator	MenACWY 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. Receives: Biological: MenACWY; Biological: Placebo

What is being measured

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

Stages 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) (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.
Measured: 7 days post dose 1 (Day 8)
Stages 1 and 2: Number of Participants With Solicited Local AEs (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.
Measured: 7 days post dose 2 (Day 64)
Stage 1: Number of Participants With Solicited Local AEs (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.
Measured: 7 days post dose 3 (Day 738)
Stages 1 and 2: Number of Participants With Solicited Systemic AEs (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).
Measured: 7 days post dose 1 (Day 8)
Stages 1 and 2: Number of Participants With Solicited Systemic AEs (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).
Measured: 7 days post dose 2 (Day 64)
Stage 1: Number of Participants With Solicited Systemic AEs (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).
Measured: 7 days post dose 3 (Up to Day 738)
Stages 1: Number of Participants With Serious Adverse Events (SAEs)
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.
Measured: Up to 36 months
Stages 2: Number of Participants With SAEs
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.
Measured: Up to 24 months
Stage 1: Number of Participants With Unsolicited AEs (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.
Measured: 28 days post booster dose (Day 759)
Stage 1: Number of Participants With Unsolicited AEs (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.
Measured: 28 days post dose 1 (Day 29)
Stage 2: Number of Participants With Unsolicited AEs (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.
Measured: 28 days post dose 1 (Day 29)
Stage 1: Number of Participants With Unsolicited AEs (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.
Measured: 28 days post dose 2 (Day 85)
Stage 2: Number of Participants With Unsolicited AEs (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.
Measured: 28 days post dose 2 (Day 85)
Stage 1: Number of Participants With Deaths
Number of participants with deaths were reported.
Measured: Up to 36 months
Stage 2: Number of Participants With Deaths (Children and Adolescents)
Number of participants (children and adolescents) with deaths were reported.
Measured: Up to 12 months
Stage 2: Number of Participants With Deaths (Adults)
Number of participants (adults) with deaths were reported.
Measured: Up to 24 months
Stage 1: Number of Participants With Immediate Reportable Event (IREs)
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.
Measured: Up to 36 months
Stage 2: Number of Participants With IREs (Children and Adolescents)
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.
Measured: Up to 12 months
Stage 2: Number of Participants With IREs (Adults)
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.
Measured: Up to 24 months

Secondary outcomes (1)

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)
GMCs of antibodies binding to EBOV GP using ELISA were reported and were measured in ELISA units per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using 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).
Measured: 21 days post-dose 2 (Day 78)

Timeline

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

30 Sep 20153 Jul 2019

First posted28 Jul 2015 (estimated)
Study start30 Sep 2015
Primary completion28 Jun 2019
Study completion3 Jul 2019

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 (5)Papers the sponsor has linked to this study.
Other trials for Ebola Virus 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,023 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02509494
Sponsor's protocol ID: CR107372
Other IDs: VAC52150EBL3001, 115854 EBOVAC1, 2019-000691-42, 2019
Acronym: EBOVAC-Salone
Status last verified: Jun 2022
First submitted: 24 Jun 2015
Last updated: 18 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated device: No

Publications

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
Manno D, Patterson C, Drammeh A, Tetteh K, Kroma MT, Otieno GT, Lawal BJ, Soremekun S, Ayieko P, Gaddah A, Kamara AB, Baiden F, Afolabi MO, Tindanbil D, Owusu-Kyei K, Ishola D, Deen GF, Keshinro B, Njie Y, Samai M, Lowe B, Robinson C, Leigh B, Drakeley C, Greenwood B, Watson-Jones D. The Effect of Previous Exposure to Malaria Infection and Clinical Malaria Episodes on the Immune Response to the Two-Dose Ad26.ZEBOV, MVA-BN-Filo Ebola Vaccine Regimen. Vaccines (Basel). 2023 Aug 2;11(8):1317. doi: 10.3390/vaccines11081317.
PubMed 37631885
Ishola D, Manno D, Afolabi MO, Keshinro B, Bockstal V, Rogers B, Owusu-Kyei K, Serry-Bangura A, Swaray I, Lowe B, Kowuor D, Baiden F, Mooney T, Smout E, Kohn B, Otieno GT, Jusu M, Foster J, Samai M, Deen GF, Larson H, Lees S, Goldstein N, Gallagher KE, Gaddah A, Heerwegh D, Callendret B, Luhn K, Robinson C, Leyssen M, Greenwood B, Douoguih M, Leigh B, Watson-Jones D; EBL3001 study group. Safety and long-term immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Sierra Leone: a combined open-label, non-randomised stage 1, and a randomised, double-blind, controlled stage 2 trial. Lancet Infect Dis. 2022 Jan;22(1):97-109. doi: 10.1016/S1473-3099(21)00125-0. Epub 2021 Sep 13.
PubMed 34529963
Afolabi MO, Ishola D, Manno D, Keshinro B, Bockstal V, Rogers B, Owusu-Kyei K, Serry-Bangura A, Swaray I, Lowe B, Kowuor D, Baiden F, Mooney T, Smout E, Kohn B, Otieno GT, Jusu M, Foster J, Samai M, Deen GF, Larson H, Lees S, Goldstein N, Gallagher KE, Gaddah A, Heerwegh D, Callendret B, Luhn K, Robinson C, Greenwood B, Leyssen M, Douoguih M, Leigh B, Watson-Jones D; EBL3001 study group. Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in children in Sierra Leone: a randomised, double-blind, controlled trial. Lancet Infect Dis. 2022 Jan;22(1):110-122. doi: 10.1016/S1473-3099(21)00128-6. Epub 2021 Sep 13.
PubMed 34529962
Mooney T, Smout E, Leigh B, Greenwood B, Enria L, Ishola D, Manno D, Samai M, Douoguih M, Watson-Jones D. EBOVAC-Salone: Lessons learned from implementing an Ebola vaccine trial in an Ebola-affected country. Clin Trials. 2018 Oct;15(5):436-443. doi: 10.1177/1740774518780678. Epub 2018 Jun 12.
PubMed 29895178

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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All Ebola Virus Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Staged Phase 3 Study, Including a Double-Blinded Controlled Stage to Evaluate the Safety and Immunogenicity of Ad26.ZEBOV and MVA-BN-Filo as Candidate Prophylactic Vaccines for Ebola
ClinicalTrials.gov ID: NCT02509494
Acronym / sponsor ID: EBOVAC-Salone / CR107372
Conditions: Ebola Virus Disease
Keywords: Vaccine, Ebola, Ebola virus disease, EVD, Hemorrhagic fever, Sierra Leone, Human adenovirus serotype 26 (Ad26) encoding the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV), Safety
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,023 participants (actual)
Lead sponsor: Janssen Vaccines & Prevention B.V.Industry (pharma, biotech, devices)
Collaborators: London School of Hygiene and Tropical Medicine, Ministry of Health and Sanitation, Sierra Leone, University of Sierra Leone, University of Oxford, Institut National de la Santé Et de la Recherche Médicale, France, Grameen Foundation, World Vision, Ireland
Study start: 30 Sep 2015 (actual)
Primary completion: 28 Jun 2019 (actual)
Study completion: 3 Jul 2019 (actual)
First posted: 28 Jul 2015 (estimated)
Results: Posted 18 Jul 2022

Clinical summary

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

The purpose of this study is the evaluation of the safety and immunogenicity of two candidate Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo, in a 2-dose heterologous regimen.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Stage 1: Active vaccination	Experimental	Biological: Ad26.ZEBOV, Biological: MVA-BN-FiloAd26.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 vaccination	Experimental	Biological: Ad26.ZEBOV, Biological: MVA-BN-FiloAd26.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 children	Experimental	Biological: Ad26.ZEBOV, Biological: MVA-BN-FiloAd26.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 vaccination	Active comparator	Biological: MenACWY, Biological: PlaceboMenACWY 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 children	Active comparator	Biological: MenACWY, Biological: PlaceboMenACWY 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.

Who may qualify

Ages: 1 year and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (9 listed)

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 from study area within the next 5 months
Participant must be healthy with no abnormalities in laboratory screening tests within 28 days before Dose 1 vaccination
Female participants of childbearing potential must use adequate birth control measures and must have a negative pregnancy test at screening and immediately prior to each study vaccination
Participant must pass the test of understanding (TOU)

Key exclusion criteria (7 listed)

Diagnosed with EVD or under quarantine/exposed to Ebola or body temperature equal of >= 38 degree Celsius (fever)
Having an acute illness (mild in nature that can be treated at home) or any clinically significant acute/chronic medical condition or having a decreased number of red blood cells/hemoglobin in the blood (anemia)
Previously participated in another Ebola interventional study or received any Ad26/MVA-based candidate vaccine
Vaccinated with live attenuated vaccines within 30 days or with inactivated vaccines 15 days before Dose 1 vaccination
Treated with an immunosuppressive drug at the time of screening

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
Ad26.ZEBOVEbola Zaire vaccine, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5*10^10 viral particles.	Biological	Stage 1: Active vaccination, Stage 2: Active vaccination, Stage 2: Active vaccination for children
MVA-BN-FiloMVA-BN-Filo- is a non-replicating vaccine, 0.5 mL IM injection of 1*10^8 Infectious Unit (Inf. U.).	Biological	Stage 1: Active vaccination, Stage 2: Active vaccination, Stage 2: Active vaccination for children
MenACWYMenACWY is a WHO-prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine.	Biological	Stage 2: Control vaccination, Stage 2: Control vaccination for children
Placebo0.9% saline for injection.	Biological	Stage 2: Control vaccination, Stage 2: Control vaccination for children

Primary outcome

Stages 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) (Day 8)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Up to 36 months
Number of participants with deaths were reported.
Stage 2: Number of Participants With Deaths (Children and Adolescents)
Time frame: Up to 12 months
Number of participants (children and adolescents) with deaths were reported.
Stage 2: Number of Participants With Deaths (Adults)
Time frame: Up to 24 months
Number of participants (adults) with deaths were reported.
Stage 1: Number of Participants With Immediate Reportable Event (IREs)
Time frame: 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)
Time frame: 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)
Time frame: 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.

1 secondary outcome

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)
Time frame: 21 days post-dose 2 (Day 78)

Results and safety

Results posted to the registry on 18 Jul 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)	43	28
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo	298	217
Stage 2 (>=18 Years): MenACWY, Placebo	102	64
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo	143	132
Stage 2 (12-17 Years): MenACWY, Placebo	48	43
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo	144	133
Stage 2 (4-11 Years): MenACWY, Placebo	48	45
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo	144	137
Stage 2 (1-3 Years): MenACWY, Placebo	48	46

Primary outcome: Stages 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) (Day 8)

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

Measure	Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) n = 43	Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo n = 298	Stage 2 (>=18 Years): MenACWY, Placebo n = 102	Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo n = 143	Stage 2 (12-17 Years): MenACWY, Placebo n = 48	Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo n = 144	Stage 2 (4-11 Years): MenACWY, Placebo n = 48	Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo n = 144	Stage 2 (1-3 Years): MenACWY, Placebo n = 48
Value	12	51	17	14	3	30	2	21	5

Population analysed: The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.

Primary outcome: Stages 1 and 2: Number of Participants With Solicited Local AEs (Day 64)

Time frame: 7 days post dose 2 (Day 64). Count of participants. Unit: Participants

Measure	Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) n = 43	Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo n = 246	Stage 2 (>=18 Years): MenACWY, Placebo n = 86	Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo n = 142	Stage 2 (12-17 Years): MenACWY, Placebo n = 46	Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo n = 143	Stage 2 (4-11 Years): MenACWY, Placebo n = 48	Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo n = 143	Stage 2 (1-3 Years): MenACWY, Placebo n = 48
Value	6	58	8	21	1	22	5	7	0

Population analysed: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

Primary outcome: Stage 1: Number of Participants With Solicited Local AEs (Day 738)

Time frame: 7 days post dose 3 (Day 738). Count of participants. Unit: Participants

Measure	Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) n = 29
Value	5

Population analysed: The FAS included all participants who received booster dose with Ad26.ZEBOV, regardless of the occurrence of protocol deviations. This outcome measure was only planned for participants who received booster vaccination with Ad26.ZEBOV hence other arms are not reported.

Primary outcome: Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 8)

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

Measure	Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) n = 43	Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo n = 298	Stage 2 (>=18 Years): MenACWY, Placebo n = 102	Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo n = 143	Stage 2 (12-17 Years): MenACWY, Placebo n = 48	Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo n = 144	Stage 2 (4-11 Years): MenACWY, Placebo n = 48	Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo n = 144	Stage 2 (1-3 Years): MenACWY, Placebo n = 48
Value	18	161	51	52	14	45	15	36	12

Population analysed: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)	3 of 43 (7%)	22 of 43 (51.2%)	0 of 43
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo	16 of 298 (5.4%)	194 of 298 (65.1%)	1 of 298
Stage 2 (>=18 Years): MenACWY, Placebo	4 of 102 (3.9%)	63 of 102 (61.8%)	0 of 102
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo	0 of 143 (0%)	56 of 143 (39.2%)	0 of 143
Stage 2 (12-17 Years): MenACWY, Placebo	1 of 48 (2.1%)	18 of 48 (37.5%)	1 of 48
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo	5 of 144 (3.5%)	69 of 144 (47.9%)	0 of 144
Stage 2 (4-11 Years): MenACWY, Placebo	0 of 48 (0%)	21 of 48 (43.8%)	0 of 48
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo	15 of 144 (10.4%)	108 of 144 (75%)	1 of 144
Stage 2 (1-3 Years): MenACWY, Placebo	3 of 48 (6.3%)	38 of 48 (79.2%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 37631885Manno D, Patterson C, Drammeh A, Tetteh K, Kroma MT, Otieno GT, Lawal BJ, Soremekun S, Ayieko P, Gaddah A, Kamara AB, Baiden F, Afolabi MO, Tindanbil D, Owusu-Kyei K, Ishola D, Deen GF, Keshinro B, Njie Y, Samai M, Lowe B, Robinson C, Leigh B, Drakeley C, Greenwood B, Watson-Jones D. The Effect of Previous Exposure to Malaria Infection and Clinical Malaria Episodes on the Immune Response to the Two-Dose Ad26.ZEBOV, MVA-BN-Filo Ebola Vaccine Regimen. Vaccines (Basel). 2023 Aug 2;11(8):1317. doi: 10.3390/vaccines11081317.
Derived from this study: PubMed 34529963Ishola D, Manno D, Afolabi MO, Keshinro B, Bockstal V, Rogers B, Owusu-Kyei K, Serry-Bangura A, Swaray I, Lowe B, Kowuor D, Baiden F, Mooney T, Smout E, Kohn B, Otieno GT, Jusu M, Foster J, Samai M, Deen GF, Larson H, Lees S, Goldstein N, Gallagher KE, Gaddah A, Heerwegh D, Callendret B, Luhn K, Robinson C, Leyssen M, Greenwood B, Douoguih M, Leigh B, Watson-Jones D; EBL3001 study group. Safety and long-term immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Sierra Leone: a combined open-label, non-randomised stage 1, and a randomised, double-blind, controlled stage 2 trial. Lancet Infect Dis. 2022 Jan;22(1):97-109. doi: 10.1016/S1473-3099(21)00125-0. Epub 2021 Sep 13.
Derived from this study: PubMed 34529962Afolabi MO, Ishola D, Manno D, Keshinro B, Bockstal V, Rogers B, Owusu-Kyei K, Serry-Bangura A, Swaray I, Lowe B, Kowuor D, Baiden F, Mooney T, Smout E, Kohn B, Otieno GT, Jusu M, Foster J, Samai M, Deen GF, Larson H, Lees S, Goldstein N, Gallagher KE, Gaddah A, Heerwegh D, Callendret B, Luhn K, Robinson C, Greenwood B, Leyssen M, Douoguih M, Leigh B, Watson-Jones D; EBL3001 study group. Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in children in Sierra Leone: a randomised, double-blind, controlled trial. Lancet Infect Dis. 2022 Jan;22(1):110-122. doi: 10.1016/S1473-3099(21)00128-6. Epub 2021 Sep 13.
Derived from this study: PubMed 29895178Mooney T, Smout E, Leigh B, Greenwood B, Enria L, Ishola D, Manno D, Samai M, Douoguih M, Watson-Jones D. EBOVAC-Salone: Lessons learned from implementing an Ebola vaccine trial in an Ebola-affected country. Clin Trials. 2018 Oct;15(5):436-443. doi: 10.1177/1740774518780678. Epub 2018 Jun 12.

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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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ad26.ZEBOV, MVA-BN-Filo and MenACWY in people with Ebola Virus Disease, run by Janssen Vaccines & Prevention B.V. at 1 site in Sierra Leone.

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 9 inclusion and 7 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 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sierra Leone. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 18 Jul 2022). 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?

Stages 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) (Day 8) (time frame: 7 days post dose 1 (Day 8)). The study lists 19 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 NCT02509494, which also lists 5 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 18 Jul 2022.