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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Ebola Virus Disease

Treatments: Biological: MenACWY; Biological: MVA-BN-Filo; Biological: Ad26.ZEBOV

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03929757

2021-001331-10 (EudraCT Number)

VAC52150EBL2005 (Other Identifier)

CR108617

Details and patient eligibility

About

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 (Main Study) and also to provide the heterologous 2-dose vaccination regimen (Ad26.ZEBOV on Day 1 and MVABN-Filo on Day 57) to participants in the control arm of the main study (Extension Phase).

Enrollment: 108 patients

Sex: All

Ages: 4 to 11 months old

Volunteers: Accepts Healthy Volunteers

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)
• Extension Phase: Prior enrollment in the control arm of the main study and did not withdraw consent, and receipt of at least the first vaccination (Dose 1) in the main study

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 chicken or egg proteins and aminoglycosides (gentamicin)
• 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
• Extension Phase: Having received any candidate or other Ebola vaccine

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 2 patient groups

Arm 1: Ad26.ZEBOV, MVA-BN-Filo

Experimental group

Description:

Participants will be administered 0.5 mL of Ad26.ZEBOV vaccine (5\*10\^10 viral particles \[vp\]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of MVA-BN-Filo (1\*10\^8 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. Upon completion of the main study, participants in the extension phase who were originally randomized to the control arm will receive the same vaccine regimen as the participants in the Ad26.ZEBOV, MVA-BN-Filo arm of the main study.

Treatment:

Biological: Ad26.ZEBOV

Biological: MVA-BN-Filo

Biological: MenACWY

Arm 2: MenACWY

Active Comparator group

Description:

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.

Treatment:

Biological: MenACWY