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A Study to Evaluate A Range of Dose Levels of Ad26.ZEBOV and MVA‐BN‐Filo in Healthy 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02543567
Recruitment Status : Completed
First Posted : September 7, 2015
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

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.

Condition or disease Intervention/treatment Phase
Healthy Biological: Ad26.ZEBOV 5*10^10 viral particles (vp) Biological: Ad26.ZEBOV 2*10^10 (vp) Biological: Ad26.ZEBOV 0.8*10^10 (vp) Biological: MVA‐BN‐Filo 1*10^8 Infectious Unit [Inf. U.] Biological: MVA‐BN‐Filo 5*10^7 Inf. U. Biological: Placebo Phase 3

Detailed Description:
This is a randomized, double‐blind, placebo‐controlled, parallel‐group, multicenter study to evaluate safety and immunogenicity of Ad26.ZEBOV and MVA‐BN‐Filo at different dose levels, administered to healthy adults participants. The study consists of a Screening period of up to 6 weeks, vaccinations on Day 1 and Day 57, and a post‐vaccination phase until the 6 months post‐boost visit (Day 237). The participants will be randomized at baseline (on Day 1) in a 2:2:2:1 ratio to Groups 1, 2, 3 and 4. Safety will be monitored throughout the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 525 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 A Range of Dose Levels of a Heterologous Prime‐Boost Regimen of Ad26.ZEBOV and MVA‐BN®‐Filo in Healthy Adult Subjects
Actual Study Start Date : September 21, 2015
Actual Primary Completion Date : June 7, 2016
Actual Study Completion Date : November 29, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

Arm Intervention/treatment
Experimental: Group 1
Ad26.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
Biological: Ad26.ZEBOV 5*10^10 viral particles (vp)
Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 5*10^10 viral particles on Day 1

Biological: MVA‐BN‐Filo 1*10^8 Infectious Unit [Inf. U.]
MVA‐BN‐Filo‐ live replication incompetent vaccine, IM injection of 1*10^8 Infectious Unit [Inf. U.] once on Day 57

Experimental: Group 2
Ad26.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
Biological: Ad26.ZEBOV 2*10^10 (vp)
Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 2*10^10 viral particles on Day 1

Biological: MVA‐BN‐Filo 5*10^7 Inf. U.
MVA‐BN‐Filo‐ live replication incompetent vaccine, IM injection of 5*10^7 Inf. U. once on Day 57

Experimental: Group 3
Ad26.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
Biological: Ad26.ZEBOV 0.8*10^10 (vp)
Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 0.8*10^10 viral particles on Day 1

Biological: MVA‐BN‐Filo 5*10^7 Inf. U.
MVA‐BN‐Filo‐ live replication incompetent vaccine, IM injection of 5*10^7 Inf. U. once on Day 57

Experimental: Group 4
Participants will receive intramuscular (IM) injection of Placebo (0.9% saline) once on Day 1 and Day 57
Biological: Placebo
One 0.5 ml IM injection of 0.9% saline administered once on Day 1 and Day 57




Primary Outcome Measures :
  1. Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein Enzyme‐linked Immunosorbent Assay (ELISA) [ Time Frame: At 21 days post boost vaccination ]
    The humoral immune response will be assessed by enzyme‐linked immunosorbent assay (ELISA) binding antibody


Secondary Outcome Measures :
  1. Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein Enzyme‐linked Immunosorbent Assay (ELISA) [ Time Frame: At Days 1, 29, 57 post prime dose and at days 42, and 180 post boost vaccination ]
    The humoral immune response will be assessed by enzyme‐linked immunosorbent assay (ELISA) binding antibody

  2. Number of Participants with Solicited Local and Systemic Adverse Events (AEs) [ Time Frame: Up to 7 days after each vaccination ]
  3. Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 42 days post boost vaccination ]
  4. Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Continuous throughout the duration of study (Up to Day 237) ]


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 :

  • 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

Exclusion criteria:

  • 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

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): NCT02543567


Locations
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United States, Alabama
Huntsville, Alabama, United States
United States, California
San Diego, California, United States
United States, Florida
Melbourne, Florida, United States
United States, Illinois
Peoria, Illinois, United States
United States, Indiana
Mishawaka, Indiana, United States
United States, Maryland
Rockville, Maryland, United States
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.

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Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT02543567     History of Changes
Other Study ID Numbers: CR107861
VAC52150EBL3002 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Vaccines & Prevention B.V.:
Ebola viruses
Ebola virus disease (EVD)
Filoviruses
Monovalent vaccine
Safety
Immunogenicity
Ebola vaccine
Human adenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV)
Modified Vaccinia Virus Ankara ‐ Bavarian Nordic Filo‐vector (MVA‐BN Filo)
Healthy participants
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs