NCT03929757

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Janssen Vaccines & Prevention B.V. · Industry
• Sex: All
• Age: 4 Months – 11 Months
• Healthy volunteers: Accepted

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).

Conditions

• Ebola Virus Disease

Interventions

Type	Name	Description
BIOLOGICAL	Ad26.ZEBOV	Participants will receive 0.5 mL IM injection of Ad26.ZEBOV as first vaccination.
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.

Timeline

• Start date: 2019-08-19
• Primary completion: 2022-08-22
• Completion: 2022-09-28
• First posted: 2019-04-29
• Last updated: 2025-05-25
• Results posted: 2023-06-22

Locations

2 sites across 2 countries: Guinea, Sierra Leone

Regulatory

• FDA-regulated drug study