Two Doses of GHB04L1 for Pandemic Influenza Prophylaxis in Healthy Adults

GHB04L1 is intended to provide a novel treatment approach for influenza virus H5N1 infection. Based on preclinical data from ferrets that demonstrated protection against challenge with wild‐type virus following treatment with various dose levels of GHB04L1, vaccination with GHB04L1 might protect humans from influenza A (H5N1) virus infection. Due to the lack of the NS1 protein, the ΔNS1 virus replicates efficiently in interferon‐deficient cells but has lost its ability to grow in normal hosts and organisms. Immunisation with ΔNS1 mutant virus can cause only an abortive replication cycle in the nasal mucosa of vaccinated individuals. This allows development of replication‐deficient intranasal vaccines with genetic stability of the attenuated phenotype and without virus shedding.