Clinical trial NCT03929757: A Study of 2-dose Vaccination Regimen of Ad26.ZEBOV and MVA-BN-Filo in Infants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ebola Virus Disease
Lead sponsor: Janssen Vaccines & Prevention B.V.
Sponsor class: INDUSTRY
Collaborators: name: London School of Hygiene and Tropical Medicine
name: University of Sierra Leone
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2019-04-29
Enrollment: 108
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 (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).


Eligibility 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)
* 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

Primary outcomes:
measure: Main Study: Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) up to 7 Days Post-dose 1
timeFrame: From dose 1 (Day 1) up to 7 days post-dose 1 (Day 8)
measure: Main Study: Percentage of Participants With Solicited Local and Systemic AEs up to 7 Days Post-dose 2
timeFrame: From dose 2 (Day 57) up to 7 days post-dose 2 (Day 64)
measure: Main Study: Percentage of Participants With Unsolicited AEs up to 28 Days Post-dose 1
timeFrame: From dose 1 (Day 1) up to 28 days post-dose 1 (Day 29)
measure: Main Study: Percentage of Participants With Unsolicited AEs up to 28 Days Post-dose 2
timeFrame: From dose 2 (Day 57) up to 28 days post-dose 2 (Day 85)
measure: Main Study: Percentage of Participants With Serious Adverse Events (SAEs) up to 6 Months Post Dose-2 on Day 57
timeFrame: Up to 6 months post dose-2 on Day 57 (Up to 8 months)
measure: Main Study: Percentage of Participants With SAEs Related to Study Intervention
timeFrame: Up to Day 365
Secondary outcomes:
measure: Main Study: Geometric Mean of Binding Antibody Levels Against the Ebola Virus Glycoprotein (EBOV GP)
timeFrame: 21 days post-dose 2 (Day 78)
Other outcomes:
Locations:
city: Conakry
country: Guinea
facility: Centre National de Formation et de Recherche en Sante Rurale de Maferinyah
city: Freetown
country: Sierra Leone
facility: College of Med and Allied Health Sciences, University of Sierra Leone
Study officials:
affiliation: Janssen Vaccines & Prevention B.V.
name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: STUDY_DIRECTOR
References: