A Study to Evaluate A Range of Dose Levels of Ad26.ZEBOV and MVA-BN-Filo in Healthy Adult Participants
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate A Range of Dose Levels of a Heterologous Prime-Boost Regimen of Ad26.ZEBOV and MVA-BN®-Filo in Healthy Adult Subjects
2 other identifiers
interventional
525
1 country
6
Brief Summary
The purpose of this study is to demonstrate the non-inferiority of a heterologous prime-boost regimen using Ad26.ZEBOV as prime and MVA-BN-Filo as boost administered at different doses at a 56-day interval versus the same regimen with the recently released batches of Ad26.ZEBOV and MVA-BN-Filo in terms of humoral immune response against the Ebola virus (EBOV) GP (glycoprotein) as measured by enzyme-linked immunosorbent assay (ELISA) at 21 days post boost.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 healthy
Started Sep 2015
Typical duration for phase_3 healthy
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2015
CompletedFirst Posted
Study publicly available on registry
September 7, 2015
CompletedStudy Start
First participant enrolled
September 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 29, 2016
CompletedMay 25, 2025
May 1, 2025
9 months
September 4, 2015
May 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein Enzyme-linked Immunosorbent Assay (ELISA)
The humoral immune response will be assessed by enzyme-linked immunosorbent assay (ELISA) binding antibody
At 21 days post boost vaccination
Secondary Outcomes (4)
Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein Enzyme-linked Immunosorbent Assay (ELISA)
At Days 1, 29, 57 post prime dose and at days 42, and 180 post boost vaccination
Number of Participants with Solicited Local and Systemic Adverse Events (AEs)
Up to 7 days after each vaccination
Number of Participants with Adverse Events (AEs)
Up to 42 days post boost vaccination
Number of Participants with Serious Adverse Events (SAEs)
Continuous throughout the duration of study (Up to Day 237)
Study Arms (4)
Group 1
EXPERIMENTALAd26.ZEBOV 5\*10\^10 viral particles (vp) single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 1\*10\^8 Infectious Unit \[Inf. U.\] single dose IM injection on Day 57
Group 2
EXPERIMENTALAd26.ZEBOV 2\*10\^10 vp single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 5\*10\^7 Inf. U single dose IM injection on Day 57
Group 3
EXPERIMENTALAd26.ZEBOV 0.8\*10\^10 vp single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 5\*10\^7 Inf. U. single dose IM injection on Day 57
Group 4
EXPERIMENTALParticipants will receive intramuscular (IM) injection of Placebo (0.9% saline) once on Day 1 and Day 57
Interventions
Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 5\*10\^10 viral particles on Day 1
Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 2\*10\^10 viral particles on Day 1
Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 0.8\*10\^10 viral particles on Day 1
MVA-BN-Filo- live replication incompetent vaccine, IM injection of 1\*10\^8 Infectious Unit \[Inf. U.\] once on Day 57
MVA-BN-Filo- live replication incompetent vaccine, IM injection of 5\*10\^7 Inf. U. once on Day 57
One 0.5 ml IM injection of 0.9% saline administered once on Day 1 and Day 57
Eligibility Criteria
You may qualify if:
- Must be healthy in the Investigator's clinical judgment on the basis of medical history, physical examination, electrocardiogram (ECG) and vital signs performed at Screening
- Must be healthy on the basis of clinical laboratory tests performed at Screening
- Before randomization, a woman must be either of childbearing potential and practicing (or intending to practice) a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for participants participating in clinical studies, beginning at least 28 days prior to vaccination OR not of childbearing potential: postmenopausal \[greater than (\>)\] 45 years of age with amenorrhea for at least 2 years or any age with amenorrhea for at least 6 months, and a serum follicle stimulating hormone (FSH) level \>40 international unit per milliliter (IU/L); permanently sterilized (for example, bilateral tubal occlusion \[which includes tubal ligation procedures as consistent with local regulations\], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy
- Woman of childbearing potential must have a negative serum \[beta-human chorionic gonadotropin (beta-hCG)\] at Screening and a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration
- Man who is sexually active with a woman of childbearing potential and has not had a vasectomy performed more than 1 year prior to Screening must be willing to use condoms for sexual intercourse beginning prior to enrollment, in addition to the birth control method used by the female partner
You may not qualify if:
- Having received a candidate Ebola vaccine
- Diagnosed with Ebola virus disease, or prior exposure to Ebola virus, including travel to West Africa less than 1 month prior to Screening. West Africa includes but is not limited to the countries of Guinea, Liberia, Mali, and Sierra Leone
- Having received any experimental candidate adenovirus serotype 26 (vector: Ad26) or Modified Vaccinia Ankara (MVA)- based vaccine in the past
- 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 or temperature greater than or equal to (\>=) 38.0 (°C) centigrade on Day 1
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Unknown Facility
Huntsville, Alabama, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Melbourne, Florida, United States
Unknown Facility
Peoria, Illinois, United States
Unknown Facility
Mishawaka, Indiana, United States
Unknown Facility
Rockville, Maryland, United States
Related Publications (1)
Bockstal V, Gaddah A, Goldstein N, Shukarev G, Bart S, Luhn K, Robinson C, Anumendem D, Leyssen M, Douoguih M. Assessments of different batches and dose levels of a two-dose Ad26.ZEBOV and MVA-BN-Filo vaccine regimen. NPJ Vaccines. 2021 Dec 20;6(1):157. doi: 10.1038/s41541-021-00402-8.
PMID: 34930928DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Vaccines & Prevention B.V. Clinical Trial
Janssen Vaccines & Prevention B.V.
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
September 4, 2015
First Posted
September 7, 2015
Study Start
September 21, 2015
Primary Completion
June 7, 2016
Study Completion
November 29, 2016
Last Updated
May 25, 2025
Record last verified: 2025-05