Ebola vaccine in healthy infants

Janssen Vaccines & Prevention B.V.

Yazdan Yazdanpanah MD, PhD-AP-HP

• Main study : A Phase 2 study to evaluate the safety, reactogenicity, and immunogenicity of Ad26.ZEBOV (first vaccination) followed by MVA-BN-Filo (second vaccination) administered 56 days later in healthy infants aged 411 months in Guinea and Sierra Leone. Infants are enrolled and randomized to study vaccine (Ad26.ZEBOV, MVA-BN-Filo) or active control (WHO-prequalified Meningococcal Group A, C, W135, and Y conjugate vaccine MenACWY) in a blinded fashion. Participants are followed during one year.
• Extension phase : Participants who were originally randomized to the control arm and who have not withdrawn during the main study, will be offered the Ebola vaccine regimen. Participants are followed during 3 months.

Phase 2, randomized, active-controlled, double-blind study to evaluate a study vaccine

• Main study : To assess the safety and reactogenicity of a heterologous 2-dose vaccination 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.
• Extension phase : To provide the heterologous 2-dose vaccination regimen (Ad26.ZEBOV on Day 1 and MVA-BN-Filo on Day 57) to participants in the control arm of the main study.

• Main study : Solicited local and systemic adverse events until 7 days post-dose-1 and 7 days post-dose2.
  Unsolicited adverse events from the first vaccination until 28 days post-dose-1 and from the second vaccination until 28 days postdose2.
  Any serious adverse events until 6 months post-dose-2, and serious adverse events related to study intervention until the end of the study.
• Extension phase : Completion of the heterologous 2-dose vaccination regimen (Ad26.ZEBOV on Day 1 and MVA-BN-Filo on Day 57).

Healthy infants aged 411 months from Guinea and Sierra Leone

• Main study : Infants in the study vaccine arm receive Ad26.ZEBOV on Day 1 and MVA-BN-Filo on Day 57 IM injection into the anterolateral thigh. Participants in the control arm receive the WHO-prequalified MenACWY as first vaccination on Day 1 and as second vaccination on Day 57.
  All study participants are vaccinated with MenACWY at 6 months post-dose-2 vaccination.
• Extension phase : Participants originally randomized to the control arm receive Ad26.ZEBOV on Day 1 and MVA-BN-Filo on Day 57 IM injection into the anterolateral thigh.

• Main study : 108 infants (53 in Guinea and 55 in Sierra Leone)
• Extension phase : 26 infants (12 in Guinea and 14 in Sierra Leone)

Guinea (Landreah site) and Sierra Leone (Kambia site)

• Main study : 1 year follow-up visits
• Extension phase : 3 months follow-up visits

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement #800176. This is an european project coordinated by a consortium including London School of Hygiene & Tropical Medicine (coordinator), Institut National de la Santé et de la Recherche Médicale, University of Antwerp, College of Medicine and Allied Health Sciences, and Janssen Vaccines & Prevention B.V. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Association.

Guinea trial coordination

https://clinicaltrials.gov/ct2/show/NCT03929757