Influenza, Avian Clinical Trial
Official title:
Randomised, Double-blind, Placebo-controlled, Phase I Dose- Escalation Study of Two Doses GHB04L1 in Healthy Adults
This study evaluates safety, tolerability and immunogenicity of two doses of GHB04L1, a liquid formulation of the replication- deficient influenza A/Vietnam/1203/04(H5N1)-like ∆NS1 virus in healthy adults. Subjects are randomised at a ratio of 2:1 for GHB04L1 (6.8 log10 or 7.5 log10 TCID50/dose/volunteer) or placebo.
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.
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