NCT03883113

Efficacy of MVA-NP+M1 in the Influenza H3N2 Human Challenge Model

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Barinthus Biotherapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Phase 2, single center, randomized, double blind study evaluating the safety, efficacy, and immunogenicity of MVA NP+M1 in the H3N2 human influenza challenge model; on healthy adult volunteers.

Detailed description

The study consists of an outpatient vaccination phase (155 participants), and at least 2 months later an inpatient challenge phase (134 participants). Participants are randomized 93:62 to receive either MVA-NP+M1 or Placebo. Up to 20 participants will be challenged over several 3-week blocks, and the remainder at the final 3-week block for a total of 80 MVA-NP+M1 and 54 Placebo recipients challenged.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	MVA-NP+M1	Trial Vaccine
BIOLOGICAL	Saline	Sodium Chloride Placebo
BIOLOGICAL	H3N2 (A/Belgium/2417/2015)	Challenge Agent

Timeline

• Start date: 2019-06-03
• Primary completion: 2019-12-16
• Completion: 2020-04-17
• First posted: 2019-03-20
• Last updated: 2021-03-18
• Results posted: 2021-03-18

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study