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A Study of 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN-Filo in Adult Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04228783
Recruitment Status : Recruiting
First Posted : January 14, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Brief 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 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.

Condition or disease Intervention/treatment Phase
Ebola Biological: Ad26.ZEBOV Biological: MVA-BN-Filo Biological: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 916 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : February 18, 2020
Estimated Primary Completion Date : February 27, 2021
Estimated Study Completion Date : June 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

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.
Biological: Ad26.ZEBOV
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).

Biological: MVA-BN-Filo
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.

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.
Biological: Ad26.ZEBOV
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).

Biological: MVA-BN-Filo
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.

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.
Biological: Ad26.ZEBOV
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).

Biological: MVA-BN-Filo
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.

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.
Biological: Placebo
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).

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).
Biological: Ad26.ZEBOV
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).

Biological: MVA-BN-Filo
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.

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.
Biological: Placebo
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).




Primary Outcome Measures :
  1. Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Enzyme-linked Immunosorbent Assay (ELISA) [ Time Frame: Day 78 (21 days post Dose 2) ]
    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.


Secondary Outcome Measures :
  1. Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Enzyme-linked Immunosorbent Assay (ELISA) [ Time Frame: Day 57 (56 days post Dose 1) ]
    Serum concentration of antibodies binding to EBOV GP measured 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.

  2. Number of Participants with Solicited Local and Systemic Adverse Events (AEs) [ Time Frame: 7 days after each vaccination (up to Day 64) ]
    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.

  3. Number of Participants with Unsolicited AEs [ Time Frame: 28 days after each vaccination (up to Day 85) ]
    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).

  4. Number of Participants with Serious AEs [ Time Frame: Up to Day 237 ]
    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.


Other Outcome Measures:
  1. 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 ]
    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.

  2. Number of Participants with Solicited Local and Systemic Adverse Events (AEs) [ Time Frame: 7 days post booster vaccination (up to Day 184) ]
    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.

  3. Number of Participants with Unsolicited AEs [ Time Frame: 28 days post booster vaccination (up to Day 205) ]
    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).

  4. Number of Participants with Serious AEs [ Time Frame: Up to Day 537 ]
    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.

  5. Viral Neutralizing Antibody Levels Against the Ad26.ZEBOV [ Time Frame: Baseline (Day 1), Day 177 and Day 198 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04228783


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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United States, Alabama
Coastal Clinical Research, Inc Recruiting
Mobile, Alabama, United States, 36608
United States, Arizona
Clinical Research Consortium, an AMR company Active, not recruiting
Tempe, Arizona, United States, 85283
United States, California
WCCT Global, LLC Withdrawn
Cypress, California, United States, 90630
United States, Kentucky
Central Kentucky Research Associates, Inc. Recruiting
Lexington, Kentucky, United States, 40509
United States, Missouri
The Center For Pharmaceutical Research Recruiting
Kansas City, Missouri, United States, 64114
United States, Nevada
Clinical Research Consortium, an AMR company Recruiting
Las Vegas, Nevada, United States, 89119
United States, Tennessee
AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company Recruiting
Knoxville, Tennessee, United States, 37920
United States, Virginia
Alliance for Multispeciality Research Recruiting
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Janssen Vaccines & Prevention B.V.
Investigators
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Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.
Additional Information:
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Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT04228783    
Other Study ID Numbers: CR108694
VAC52150EBL3004 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
First Posted: January 14, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No