Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo
EBOVAC-Salone
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
4 other identifiers
interventional
1,023
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2015
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2015
CompletedFirst Posted
Study publicly available on registry
July 28, 2015
CompletedStudy Start
First participant enrolled
September 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2019
CompletedResults Posted
Study results publicly available
July 18, 2022
CompletedJuly 18, 2022
June 1, 2022
3.7 years
June 24, 2015
June 22, 2022
June 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (19)
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.
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.
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.
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
28 days post dose 2 (Day 85)
Stage 1: Number of Participants With Deaths
Number of participants with deaths were reported.
Up to 36 months
Stage 2: Number of Participants With Deaths (Children and Adolescents)
Number of participants (children and adolescents) with deaths were reported.
Up to 12 months
Stage 2: Number of Participants With Deaths (Adults)
Number of participants (adults) with deaths were reported.
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.
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.
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.
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)
21 days post-dose 2 (Day 78)
Study Arms (5)
Stage 1: Active vaccination
EXPERIMENTALAd26.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
EXPERIMENTALAd26.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
EXPERIMENTALAd26.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 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 children
ACTIVE 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.
Interventions
Ebola Zaire vaccine, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5\*10\^10 viral particles.
MVA-BN-Filo- is a non-replicating vaccine, 0.5 mL IM injection of 1\*10\^8 Infectious Unit (Inf. U.).
MenACWY is a WHO-prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine.
0.9% saline for injection.
Eligibility Criteria
You may qualify if:
- 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)
- 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
You may not qualify if:
- 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
- \- Children up to 5 years of age with severe malnutrition (underweight or Z-score weight \<2)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Vaccines & Prevention B.V.lead
- London School of Hygiene and Tropical Medicinecollaborator
- Ministry of Health and Sanitation, Sierra Leonecollaborator
- University of Sierra Leonecollaborator
- University of Oxfordcollaborator
- Institut National de la Santé Et de la Recherche Médicale, Francecollaborator
- Grameen Foundationcollaborator
- World Vision, Irelandcollaborator
Study Sites (1)
Unknown Facility
Freetown, Sierra Leone
Related Publications (5)
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.
PMID: 38603720DERIVEDManno 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.
PMID: 37631885DERIVEDIshola 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.
PMID: 34529963DERIVEDAfolabi 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.
PMID: 34529962DERIVEDMooney 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.
PMID: 29895178DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director Clinical Franchise Lead
- Organization
- Janssen Vaccines & Prevention B.V.
Study Officials
- STUDY DIRECTOR
Janssen Vaccines & Prevention B.V. Clinical Trial
Janssen Vaccines & Prevention B.V.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2015
First Posted
July 28, 2015
Study Start
September 30, 2015
Primary Completion
June 28, 2019
Study Completion
July 3, 2019
Last Updated
July 18, 2022
Results First Posted
July 18, 2022
Record last verified: 2022-06