Safety, potential efficacy, and pharmacokinetics of specific polyclonal immunoglobulin F(ab')₂ fragments against avian influenza A (H5N1) in healthy volunteers: a single-centre, randomised, double-blind, placebo-controlled, phase 1 study.

Background: Human infection with the avian influenza A H5N1 virus results in disease with a high fatality rate, against which antiviral treatments have limited efficacy. We aimed to investigate the safety, pharmacokinetics, and therapeutic potential of specific polyclonal immunoglobulin equine F(ab')₂ fragments raised against influenza A/Vietnam/1194/2004 virus (H5N1 subtype) in healthy volunteers.

Methods: We did a randomised, double-blind, placebo-controlled, single-centre phase 1 study.