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A Study of 2-dose Vaccination Regimen of Ad26.ZEBOV and MVA-BN-Filo in Infants

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ClinicalTrials.gov Identifier: NCT03929757
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Brief Summary:
The purpose of this study is to assess the safety and reactogenicity of a heterologous 2-dose regimen utilizing Ad26.ZEBOV (first vaccination; Dose 1) and MVA-BN-Filo (second vaccination; Dose 2) administered intramuscularly (IM) on Days 1 and 57, respectively.

Condition or disease Intervention/treatment Phase
Healthy Biological: Ad26.ZEBOV Biological: MVA-BN-Filo Biological: MenACWY Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of a Heterologous 2-dose Vaccination Regimen Using Ad26.ZEBOV and MVA-BN®-Filo in Infants Aged 4-11 Months in Guinea and Sierra Leone
Actual Study Start Date : August 15, 2019
Estimated Primary Completion Date : December 22, 2020
Estimated Study Completion Date : December 22, 2020

Arm Intervention/treatment
Experimental: Arm 1: Ad26.ZEBOV, MVA-BN-Filo
Participants will be administered 0.5 mL of Ad26.ZEBOV vaccine (5*1010 viral particles [vp]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of MVA-BN-Filo (1*108 infectious units [Inf U]) vaccine by IM injection on Day 57. Participants will also receive a dose of MenACWY at the 6-months post-dose-2 visit.
Biological: Ad26.ZEBOV
Participants will receive 0.5 mL IM injection of Ad26.ZEBOV as first vaccination.
Other Name: VAC52150

Biological: MVA-BN-Filo
Participants will receive 0.5 mL IM injection of MVA-BN-Filo as second vaccination.

Biological: MenACWY
Participants will receive 0.5 mL IM injection of MenACWY.

Active Comparator: Arm 2: MenACWY
Participants will be administered 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Participants will also receive a dose of MenACWY at the 6-months post-dose-2 visit.
Biological: MenACWY
Participants will receive 0.5 mL IM injection of MenACWY.




Primary Outcome Measures :
  1. Percentage of Participants with Solicited Local and Systemic Adverse Events (AEs) [ Time Frame: Up to 7 days post-dose-1 (Day 8) ]
    Following local AEs: pain, erythema, and induration at the study vaccine injection site, and systemic AEs: pyrexia, loss of appetite, vomiting, diarrhea, decreased activity, irritability will be noted in the participant diary for 7 days. The extent (largest diameter) of any redness or induration will be measured daily and recorded, along with any functional limitation of activity.

  2. Percentage of Participants with Solicited Local and Systemic AEs [ Time Frame: Up to 7 days post-dose-2 (Day 64) ]
    Following local AEs: pain, erythema, and induration at the study vaccine injection site, and systemic AEs: pyrexia, loss of appetite, vomiting, diarrhea, decreased activity, irritability will be noted in the participant diary for 7 days. The extent (largest diameter) of any redness or induration will be measured daily and recorded, along with any functional limitation of activity.

  3. Percentage of Participants with Unsolicited AEs [ Time Frame: Up to 28 days post-dose-1 (Day 29) ]
    Percentage 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.

  4. Percentage of Participants with Unsolicited AEs [ Time Frame: Up to 28 days post-dose-2 (Day 85) ]
    Percentage 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.

  5. Percentage of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 6 months post dose-2 (approximately 8 months) ]
    An SAE is any adverse event (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 and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.


Secondary Outcome Measures :
  1. Binding Antibody Levels Against the Ebola Virus Glycoprotein (EBOV GP) [ Time Frame: At 21 days post dose-2 (Day 78) ]
    Serum samples will be collected for analysis of binding antibodies against EBOV GP using filovirus animal nonclinical group enzyme-linked immunosorbent assay (FANG ELISA), to determine humoral responses following vaccination.



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Ages Eligible for Study:   4 Months to 11 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Parent(s) (preferably both if available or as per local requirements)/guardian must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for the study, and potential risks and benefits of the study, and are willing to allow their child to participate in the study
  • Parent(s)/guardian are willing/able to ensure that their child adheres to the prohibitions and restrictions
  • The parent(s)/guardian must be at or above the age of legal consent in the jurisdiction in which the study is taking place
  • Infant must be healthy in the investigator's clinical judgment (and the parent(s)/guardian) on the basis of medical history, physical examination, vital signs and clinical laboratory tests performed at screening
  • Infant has received all routine immunizations appropriate for his or her age at the time of enrollment as documented in the vaccination cards presented by the parent(s)/guardian. Participants are allowed to catch up on routine immunizations if needed (support for beneficial vaccines may be offered to participants)

Exclusion Criteria:

  • Having received any candidate or other Ebola vaccine
  • History of Ebola virus disease (EVD), or prior exposure to Ebola virus, including travel to an area with a current Ebola outbreak less than 1 month prior to screening
  • Having received any experimental candidate 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 [for example, polysorbate 80, ethylenediaminetetraacetic acid (EDTA) or L-histidine for Ad26.ZEBOV vaccine; tris (hydroxymethyl)-amino methane (THAM) for MVA-BN-Filo vaccine and Neisseria meningitidis polysaccharide or tetanus toxoid for MenACWY]), including known allergy to egg, egg products and aminoglycosides
  • Presence of acute illness (this does not include minor illnesses such as mild diarrhea or mild upper respiratory tract infection) or axillary temperature greater than or equal to (>=) 37.5 degree celsius 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

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): NCT03929757


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

Locations
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Guinea
Centre National de Formation et de Recherche en Santé Rurale de Mafèrinyah Not yet recruiting
Conakry, Guinea, 2649
Sierra Leone
College of Med and Allied Health Sciences, University of Sierra Leone Recruiting
Freetown, Sierra Leone
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: NCT03929757     History of Changes
Other Study ID Numbers: CR108617
VAC52150EBL2005 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs