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

Primary Purpose

Ebola Virus Disease

Status
Completed
Phase
Phase 3
Locations
Sierra Leone
Study Type
Interventional
Intervention
Ad26.ZEBOV
MVA-BN-Filo
MenACWY
Placebo
Sponsored by
Janssen Vaccines & Prevention B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ebola Virus Disease focused on measuring 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)

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 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:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Stage 1: Active vaccination

Stage 2: Active vaccination

Stage 2: Active vaccination for children

Stage 2: Control vaccination

Stage 2: Control vaccination for children

Arm Description

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).

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).

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.

MenACWY will be administered as a 0.5 mL IM injection on Day 1 (Dose 1) and placebo on Day 57 (Dose 2).

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
Stage 1: Number of Participants With Deaths
Number of participants with deaths were reported.
Stage 2: Number of Participants With Deaths (Children and Adolescents)
Number of participants (children and adolescents) with deaths were reported.
Stage 2: Number of Participants With Deaths (Adults)
Number of participants (adults) with deaths were reported.
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.
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.
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.

Secondary Outcome Measures

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).

Full Information

First Posted
June 24, 2015
Last Updated
June 22, 2022
Sponsor
Janssen Vaccines & Prevention B.V.
Collaborators
London School of Hygiene and Tropical Medicine, Ministry of Health and Sanitation, Sierra Leone, College of Medicine and Allied Health Sciences (COMAHS), University of Oxford, Institut National de la Santé Et de la Recherche Médicale, France, Grameen Foundation, World Vision of Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT02509494
Brief Title
Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo
Acronym
EBOVAC-Salone
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 30, 2015 (Actual)
Primary Completion Date
June 28, 2019 (Actual)
Study Completion Date
July 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Vaccines & Prevention B.V.
Collaborators
London School of Hygiene and Tropical Medicine, Ministry of Health and Sanitation, Sierra Leone, College of Medicine and Allied Health Sciences (COMAHS), University of Oxford, Institut National de la Santé Et de la Recherche Médicale, France, Grameen Foundation, World Vision of Ireland

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Immunogenicity, Modified Vaccinia Virus Ankara - Bavarian Nordic Filo-vector, (MVA-BN Filo)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1023 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stage 1: Active vaccination
Arm Type
Experimental
Arm Description
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).
Arm Title
Stage 2: Active vaccination
Arm Type
Experimental
Arm Description
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).
Arm Title
Stage 2: Active vaccination for children
Arm Type
Experimental
Arm Description
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.
Arm Title
Stage 2: Control vaccination
Arm Type
Active Comparator
Arm Description
MenACWY will be administered as a 0.5 mL IM injection on Day 1 (Dose 1) and placebo on Day 57 (Dose 2).
Arm Title
Stage 2: Control vaccination for children
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Ad26.ZEBOV
Intervention Description
Ebola Zaire vaccine, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5*10^10 viral particles.
Intervention Type
Biological
Intervention Name(s)
MVA-BN-Filo
Intervention Description
MVA-BN-Filo- is a non-replicating vaccine, 0.5 mL IM injection of 1*10^8 Infectious Unit (Inf. U.).
Intervention Type
Biological
Intervention Name(s)
MenACWY
Intervention Description
MenACWY is a WHO-prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
0.9% saline for injection.
Primary Outcome Measure Information:
Title
Stages 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) (Day 8)
Description
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.
Time Frame
7 days post dose 1 (Day 8)
Title
Stages 1 and 2: Number of Participants With Solicited Local AEs (Day 64)
Description
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.
Time Frame
7 days post dose 2 (Day 64)
Title
Stage 1: Number of Participants With Solicited Local AEs (Day 738)
Description
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.
Time Frame
7 days post dose 3 (Day 738)
Title
Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 8)
Description
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).
Time Frame
7 days post dose 1 (Day 8)
Title
Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 64)
Description
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).
Time Frame
7 days post dose 2 (Day 64)
Title
Stage 1: Number of Participants With Solicited Systemic AEs (Day 738)
Description
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).
Time Frame
7 days post dose 3 (Up to Day 738)
Title
Stages 1: Number of Participants With Serious Adverse Events (SAEs)
Description
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.
Time Frame
Up to 36 months
Title
Stages 2: Number of Participants With SAEs
Description
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.
Time Frame
Up to 24 months
Title
Stage 1: Number of Participants With Unsolicited AEs (Day 759)
Description
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.
Time Frame
28 days post booster dose (Day 759)
Title
Stage 1: Number of Participants With Unsolicited AEs (Day 29)
Description
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.
Time Frame
28 days post dose 1 (Day 29)
Title
Stage 2: Number of Participants With Unsolicited AEs (Day 29)
Description
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.
Time Frame
28 days post dose 1 (Day 29)
Title
Stage 1: Number of Participants With Unsolicited AEs (Day 85)
Description
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.
Time Frame
28 days post dose 2 (Day 85)
Title
Stage 2: Number of Participants With Unsolicited AEs (Day 85)
Description
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.
Time Frame
28 days post dose 2 (Day 85)
Title
Stage 1: Number of Participants With Deaths
Description
Number of participants with deaths were reported.
Time Frame
Up to 36 months
Title
Stage 2: Number of Participants With Deaths (Children and Adolescents)
Description
Number of participants (children and adolescents) with deaths were reported.
Time Frame
Up to 12 months
Title
Stage 2: Number of Participants With Deaths (Adults)
Description
Number of participants (adults) with deaths were reported.
Time Frame
Up to 24 months
Title
Stage 1: Number of Participants With Immediate Reportable Event (IREs)
Description
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.
Time Frame
Up to 36 months
Title
Stage 2: Number of Participants With IREs (Children and Adolescents)
Description
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.
Time Frame
Up to 12 months
Title
Stage 2: Number of Participants With IREs (Adults)
Description
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.
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
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)
Description
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).
Time Frame
21 days post-dose 2 (Day 78)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Vaccines & Prevention B.V. Clinical Trial
Organizational Affiliation
Janssen Vaccines & Prevention B.V.
Official's Role
Study Director
Facility Information:
City
Freetown
Country
Sierra Leone

12. IPD Sharing Statement

Citations:
PubMed Identifier
34529963
Citation
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. Erratum In: Lancet Infect Dis. 2023 Sep;23(9):e337.
Results Reference
derived
PubMed Identifier
34529962
Citation
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.
Results Reference
derived
PubMed Identifier
29895178
Citation
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.
Results Reference
derived

Learn more about this trial

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

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