EbolaPhase 3NCT04228783
A Study of 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN-Filo in Adult Participants
A Phase 3 study testing Ad26.ZEBOV and MVA-BN-Filo in people with Ebola, run by Janssen Vaccines & Prevention B.V. at 7 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Ebola
- What is being tested?
- Ad26.ZEBOV and MVA-BN-Filo
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 974 participants
- Where
- 7 sitesUnited States
- Study dates
- 18 Feb 2020to 25 Apr 2022
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
The Center For Pharmaceutical Research
Kansas City, Missouri, 64114
AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
Knoxville, Tennessee, 37920
Clinical Research Consortium, an AMR company
Las Vegas, Nevada, 89119
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509
Coastal Clinical Research, Inc
Mobile, Alabama, 36608
Alliance for Multispeciality Research
Norfolk, Virginia, 23502
Clinical Research Consortium, an AMR company
Tempe, Arizona, 85283
About this study
Official title: 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.
- Conditions
- Ebola
- Being tested
- Ad26.ZEBOV, MVA-BN-Filo, Placebo
- Medical subject headings
- Hemorrhagic Fever, Ebola
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad26.ZEBOVBiological
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).
MVA-BN-FiloBiological
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.
PlaceboBiological
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).
| Study group | Role | What they receive |
|---|---|---|
| Active Vaccine: Group 1 (Ad26.ZEBOV-Lot A, MVA-BN-Filo-Lot 1) | Experimental | 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. Receives: Biological: Ad26.ZEBOV; Biological: MVA-BN-Filo |
| Active Vaccine: Group 2 (Ad26.ZEBOV-Lot B, MVA-BN-Filo-Lot 2) | Experimental | 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. Receives: Biological: Ad26.ZEBOV; Biological: MVA-BN-Filo |
| Active Vaccine: Group 3 (Ad26.ZEBOV-Lot C, MVA-BN-Filo-Lot 3) | Experimental | 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. Receives: Biological: Ad26.ZEBOV; Biological: MVA-BN-Filo |
| Control Vaccine: Group 4 (Placebo) | Placebo comparator | 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. Receives: Biological: Placebo |
| Booster Cohort: Group 5 (Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV) | Experimental | 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). Receives: Biological: Ad26.ZEBOV; Biological: MVA-BN-Filo |
| Booster Cohort: Group 6 (Placebo) | Placebo comparator | 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. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 21 Days Post Vaccination 2 (Day 78)
Secondary outcomes (5)
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
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.
Measured: 56 Days Post Vaccination 1 (Day 57)
Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination 1 and 2
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.
Measured: 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)
Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination 1 and 2
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.
Measured: 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)
Number of Participants With Unsolicited Adverse Events (AEs) Until 28 Days After Vaccination 1 and 2
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.
Measured: 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)
Number of Participants With Serious Adverse Events (SAEs)
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.
Measured: Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start18 Feb 2020
- Primary completion25 Apr 2022
- Study completion25 Apr 2022
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.
- Other trials for EbolaStudies 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
- 974 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Vaccines & Prevention B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Vaccines & Prevention B.V. Clinical Trial, Study director, Janssen Vaccines & Prevention B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228783
- Sponsor's protocol ID
- CR108694
- Other IDs
- VAC52150EBL3004
- Status last verified
- May 2025
- First submitted
- 10 Jan 2020
- Last updated
- 25 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04228783
- Acronym / sponsor ID
- CR108694
- Conditions
- Ebola
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 974 participants (actual)
- Lead sponsor
- Janssen Vaccines & Prevention B.V.Industry (pharma, biotech, devices)
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 14 Jan 2020 (actual)
- Results
- Posted 17 May 2023
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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Active Vaccine: Group 1 (Ad26.ZEBOV-Lot A, MVA-BN-Filo-Lot 1) | Experimental | Biological: Ad26.ZEBOV, Biological: MVA-BN-FiloParticipants 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. |
| Active Vaccine: Group 2 (Ad26.ZEBOV-Lot B, MVA-BN-Filo-Lot 2) | Experimental | Biological: Ad26.ZEBOV, Biological: MVA-BN-FiloParticipants 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. |
| Active Vaccine: Group 3 (Ad26.ZEBOV-Lot C, MVA-BN-Filo-Lot 3) | Experimental | Biological: Ad26.ZEBOV, Biological: MVA-BN-FiloParticipants 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. |
| Control Vaccine: Group 4 (Placebo) | Placebo comparator | Biological: PlaceboParticipants 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. |
| Booster Cohort: Group 5 (Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV) | Experimental | Biological: Ad26.ZEBOV, Biological: MVA-BN-FiloParticipants 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). |
| Booster Cohort: Group 6 (Placebo) | Placebo comparator | Biological: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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.ZEBOVParticipants 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). | Biological | Active Vaccine: Group 1 (Ad26.ZEBOV-Lot A, MVA-BN-Filo-Lot 1), Active Vaccine: Group 2 (Ad26.ZEBOV-Lot B, MVA-BN-Filo-Lot 2), Active Vaccine: Group 3 (Ad26.ZEBOV-Lot C, MVA-BN-Filo-Lot 3), Booster Cohort: Group 5 (Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV) |
| MVA-BN-FiloParticipants 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. | Biological | Active Vaccine: Group 1 (Ad26.ZEBOV-Lot A, MVA-BN-Filo-Lot 1), Active Vaccine: Group 2 (Ad26.ZEBOV-Lot B, MVA-BN-Filo-Lot 2), Active Vaccine: Group 3 (Ad26.ZEBOV-Lot C, MVA-BN-Filo-Lot 3), Booster Cohort: Group 5 (Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV) |
| PlaceboParticipants 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). | Biological | Booster Cohort: Group 6 (Placebo), Control Vaccine: Group 4 (Placebo) |
Primary outcome
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)
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.
5 secondary outcomes
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)
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)
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)
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)
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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
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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.
7 sites 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 and MVA-BN-Filo in people with Ebola, run by Janssen Vaccines & Prevention B.V. at 7 sites in United States.
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 6 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 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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. Some participants in this study may receive a placebo. 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 17 May 2023). 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?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2025.