- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04228783
A Study of 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN-Filo in Adult Participants
June 2, 2023 updated by: Janssen Vaccines & Prevention B.V.
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Immunogenicity, Safety, Reactogenicity, and Consistency of a Heterologous 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN®-Filo in Adult Participants
The purpose of this study is to demonstrate that the paired 2-dose vaccine regimens from 3 consecutively manufactured lots of Adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 and 3 consecutively manufactured lots of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) including the ebola virus mayinga glycoprotein as Dose 2, administered at a 56-day interval, induce an equivalent humoral immune response.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
974
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Mobile, Alabama, United States, 36608
- Coastal Clinical Research, Inc
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Arizona
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Tempe, Arizona, United States, 85283
- Clinical Research Consortium, an AMR company
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Kentucky
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Lexington, Kentucky, United States, 40509
- Central Kentucky Research Associates, Inc.
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Missouri
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Kansas City, Missouri, United States, 64114
- The Center for Pharmaceutical Research
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Nevada
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Las Vegas, Nevada, United States, 89119
- Clinical Research Consortium, an AMR company
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Tennessee
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Knoxville, Tennessee, United States, 37920
- AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
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Virginia
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Norfolk, Virginia, United States, 23502
- Alliance for Multispeciality Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Signed an informed consent form (ICF)
- Medically stable in the investigator's clinical judgment on the basis of physical examination, medical history, and vital signs performed at screening
- Before randomization, a woman must be either: a. Not of childbearing potential; b. Of childbearing potential and practicing an acceptable effective method of birth control and agrees to remain on such a method of birth control from signing the informed consent form (ICF) until at least 3 months post Dose 1 vaccination or 28 days post Dose 2 vaccination or 3 months post booster vaccination (Groups 5-6 only), whichever comes later. Use of hormonal contraception should start at least 28 days before the first administration of study vaccine. Acceptable effective methods for this study include: 1) hormonal contraception; 2) intrauterine device (IUD); 3) intrauterine hormone-releasing system (IUS); 4) male or female condom with or without spermicide; 5) cap, diaphragm, or sponge with a vaginal spermicide; 6) vasectomized partner (the vasectomized partner should be the sole partner for that participant); 7) sexual abstinence
- Women of childbearing potential must have a negative urine Beta-human chorionic gonadotropin (Beta-hCG) pregnancy test at screening and immediately prior to each study vaccine administration
- Available and willing to participate for the duration of the study and follow-up visit
- Willing to provide verifiable identification
Exclusion Criteria:
- Having received any candidate Ebola vaccine
- Diagnosed with Ebola virus disease (EVD), or prior exposure to Ebola virus, including travel to an area with Ebola outbreak less than 1 month prior to screening (if applicable)
- Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccines), including known allergy to egg, egg products, and aminoglycosides
- Presence of acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0ºCelcius on Day 1. Participants with such symptoms will be excluded from enrollment at that time but may be rescheduled for enrollment at a later date
- Human immunodeficiency virus (HIV) type 1 or type 2 infection, based on the medical history reported by the participant
- Pregnant, breast-feeding
- History of an underlying clinically significant acute or chronic medical condition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active Vaccine: Group 1 (Ad26.ZEBOV-Lot A, MVA-BN-Filo-Lot 1)
Participants will receive Intramuscular injection (0.5 milliliter [mL]) of Adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5*10^10 viral particle(s) [vp], Lot A) on Day 1, followed by Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1*10^8 infectious unit(s) [Inf U], Lot 1) on Day 57.
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Participants will receive IM injection (0.5 mL) of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot A, B, and C) on Day 1 (Groups 1, 2, 3 and 5) and an Ad26.ZEBOV booster dose on Day 177 (Group 5).
Participants will receive IM injection (0.5 mL) of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 1, 2, 3 and 5) on Day 57.
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Experimental: Active Vaccine: Group 2 (Ad26.ZEBOV-Lot B, MVA-BN-Filo-Lot 2)
Participants will receive Intramuscular injection (0.5 mL) of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot B) on Day 1, followed by MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 2) on Day 57.
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Participants will receive IM injection (0.5 mL) of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot A, B, and C) on Day 1 (Groups 1, 2, 3 and 5) and an Ad26.ZEBOV booster dose on Day 177 (Group 5).
Participants will receive IM injection (0.5 mL) of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 1, 2, 3 and 5) on Day 57.
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Experimental: Active Vaccine: Group 3 (Ad26.ZEBOV-Lot C, MVA-BN-Filo-Lot 3)
Participants will receive Intramuscular injection (0.5 mL) of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot C) on Day 1, followed by MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 3) on Day 57.
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Participants will receive IM injection (0.5 mL) of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot A, B, and C) on Day 1 (Groups 1, 2, 3 and 5) and an Ad26.ZEBOV booster dose on Day 177 (Group 5).
Participants will receive IM injection (0.5 mL) of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 1, 2, 3 and 5) on Day 57.
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Placebo Comparator: Control Vaccine: Group 4 (Placebo)
Participants will receive Intramuscular injection (0.5 mL) of placebo (0.9 percent [%] saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by placebo matching to MVA-BN-Filo as Dose 2 on Day 57.
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Participants will receive IM injection (0.5 mL) of placebo (0.9 % saline) as Dose 1 on Day 1, followed by placebo as Dose 2 on Day 57 (Groups 4 and 6) and a booster of matching placebo on Day 177 (Group 6).
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Experimental: Booster Cohort: Group 5 (Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV)
Participants will receive Intramuscular injection (0.5 mL) of Ad26.ZEBOV as Dose 1 (5*10^10 vp, a single Lot) on Day 1, followed by MVA-BN-Filo as Dose 2 (1*10^8 Inf U, a single Lot) on Day 57 and a booster dose of Ad26.ZEBOV (at a dose of 5*10^10 vp, a single Lot) 4 months after Dose 2 (on Day 177).
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Participants will receive IM injection (0.5 mL) of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot A, B, and C) on Day 1 (Groups 1, 2, 3 and 5) and an Ad26.ZEBOV booster dose on Day 177 (Group 5).
Participants will receive IM injection (0.5 mL) of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 1, 2, 3 and 5) on Day 57.
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Placebo Comparator: Booster Cohort: Group 6 (Placebo)
Participants will receive Intramuscular injection (0.5 mL) of placebo (0.9% saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by placebo matching to MVA-BN-Filo as Dose 2 on Day 57 and a booster dose of matching placebo on Day 177.
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Participants will receive IM injection (0.5 mL) of placebo (0.9 % saline) as Dose 1 on Day 1, followed by placebo as Dose 2 on Day 57 (Groups 4 and 6) and a booster of matching placebo on Day 177 (Group 6).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against the Ebola Virus Glycoprotein (EBOV GP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) at 21 Days Post Vaccination 2
Time Frame: 21 Days Post Vaccination 2 (Day 78)
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Antibody GMCs against the EBOV GP as measured by ELISA at 21 days post Vaccination 2 were reported.
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) of 36.11
EU/mL were imputed with half of the LLOQ prior to the computation of the GMCs.
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21 Days Post Vaccination 2 (Day 78)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against the Ebola Virus Glycoprotein (EBOV GP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) at 56 Days Post Vaccination 1
Time Frame: 56 Days Post Vaccination 1 (Day 57)
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Antibody GMCs against the EBOV GP as measured by ELISA at 56 days post Vaccination 1 were reported.
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 LLOQ of 36.11
EU/mL were imputed with half of the LLOQ prior to the computation of the GMCs.
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56 Days Post Vaccination 1 (Day 57)
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Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination 1 and 2
Time Frame: Until 7 Days after Vaccination 1 on Day 1 (Up to Day 8); Until 7 Days after Vaccination 2 on Day 57 (Up to Day 64)
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An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination.
Solicited local AEs were injection site pain/tenderness, erythema, induration/swelling, itching, pruritis at the vaccination site.
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Until 7 Days after Vaccination 1 on Day 1 (Up to Day 8); Until 7 Days after Vaccination 2 on Day 57 (Up to Day 64)
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Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination 1 and 2
Time Frame: Until 7 Days after Vaccination 1 on Day 1 (Up to Day 8); Until 7 Days after Vaccination 2 on Day 57 (Up to Day 64)
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An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day.
If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary.
Fever was defined as endogenous elevation of body temperature greater than or equal to (>=) 38.0 degree Celsius or >=100.4-degree
Fahrenheit, as recorded in at least 1 measurement.
Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post vaccination 1 and 2 (day of vaccination and the subsequent 7 days), if feasible, for the following events: fatigue, headache, nausea, myalgia, arthralgia, chills, and fever.
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Until 7 Days after Vaccination 1 on Day 1 (Up to Day 8); Until 7 Days after Vaccination 2 on Day 57 (Up to Day 64)
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Number of Participants With Unsolicited Adverse Events (AEs) Until 28 Days After Vaccination 1 and 2
Time Frame: Until 28 Days After Vaccination 1 on Day 1 (Up to Day 29); until 28 days after Vaccination 2 on Day 57 (Up to Day 85)
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An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary.
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Until 28 Days After Vaccination 1 on Day 1 (Up to Day 29); until 28 days after Vaccination 2 on Day 57 (Up to Day 85)
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Number of Participants With Serious Adverse Events (SAEs)
Time Frame: Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
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SAE was 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.
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Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Enzyme-linked Immunosorbent Assay (ELISA)
Time Frame: Days 177, 184, 198, 357 and 537
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Serum concentration of antibodies binding to EBOV GP using ELISA will be reported.
Serum samples will be collected for analysis of binding antibodies against EBOV GP using ELISA to determine humoral responses following vaccination.
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Days 177, 184, 198, 357 and 537
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Number of Participants with Solicited Local and Systemic Adverse Events (AEs)
Time Frame: 7 days post booster vaccination (up to Day 184)
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Number of participants with solicited local and systemic adverse events (AEs) will be reported.
Following solicited local AEs are: pain/tenderness, erythema, induration/swelling, and pruritus and solicited systemic AEs are: fatigue, headache, nausea, myalgia, arthralgia, chills, and fever.
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7 days post booster vaccination (up to Day 184)
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Number of Participants with Unsolicited AEs
Time Frame: 28 days post booster vaccination (up to Day 205)
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Number of participants with unsolicited AEs will be evaluated.
Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary.
Unsolicited AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2) and severe (Grade 3).
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28 days post booster vaccination (up to Day 205)
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Number of Participants with Serious AEs
Time Frame: Up to Day 537
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A serious AE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important to prevent one of the outcomes listed above.
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Up to Day 537
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Viral Neutralizing Antibody Levels Against the Ad26.ZEBOV
Time Frame: Baseline (Day 1), Day 177 and Day 198
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Viral neutralizing antibody levels against the Ad26.ZEBOV will be reported.
Blood samples will be collected for analysis of viral neutralizing antibodies against Ad26 vector.
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Baseline (Day 1), Day 177 and Day 198
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial, Janssen Vaccines & Prevention B.V.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 18, 2020
Primary Completion (Actual)
April 25, 2022
Study Completion (Actual)
April 25, 2022
Study Registration Dates
First Submitted
January 10, 2020
First Submitted That Met QC Criteria
January 10, 2020
First Posted (Actual)
January 14, 2020
Study Record Updates
Last Update Posted (Actual)
June 5, 2023
Last Update Submitted That Met QC Criteria
June 2, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR108694
- VAC52150EBL3004 (Other Identifier: Janssen Vaccines & Prevention B.V.)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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