NCT02860650

A Study to Evaluate Safety, Tolerability, and Immunogenicity of Heterologous Prime-boost Regimens Using the Multivalent Filovirus Vaccines Ad26.Filo and MVA-BN-Filo Administered in Different Sequences and Schedules in Healthy Adults

A Phase 1, First-in-human Study to Evaluate Safety, Tolerability, and Immunogenicity of Heterologous Prime-boost Regimens Using the Multivalent Filovirus Vaccines Ad26.Filo and MVA-BN-Filo Administered in Different Sequences and Schedules in Healthy Adult

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Janssen Vaccines & Prevention B.V. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.Filo as heterologous prime-boost vaccine regimens in healthy adult participants.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Ad26.Filo	Ad26.Filo intramuscular (IM) injection at a dose of 9\*10\^10 viral particles (vp).
BIOLOGICAL	MVA-BN-Filo	MVA-BN-Filo intramuscular (IM) injection at a dose of 5\*10\^8 infectious units (Inf U).
BIOLOGICAL	Ad26.ZEBOV	Ad26.ZEBOV intramuscular (IM) injection at a dose of 5\*10\^10 vp.
BIOLOGICAL	Placebo	IM injection of 0.9 percent saline.
BIOLOGICAL	MVA-BN-Filo	MVA-BN-Filo intramuscular (IM) injection at a dose of 1\*10\^8 Inf U.

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-05-01
• Completion: 2018-01-01
• First posted: 2016-08-09
• Last updated: 2018-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study