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Safety and efficacy of monoclonal antibody VIS410 in adults with uncomplicated influenza A infection: Results from a randomized, double-blind, phase-2, placebo-controlled study.

ABSTRACT: BACKGROUND:VIS410, a broadly neutralizing monoclonal antibody that binds the hemagglutinin stem of influenza A viruses, was safe and efficacious in a human H1N1 virus challenge study. This study evaluated the safety and tolerability of VIS410 in non-hospitalized adult patients with uncomplicated influenza A. METHODS:Patients 18 to 65?years of age with symptom onset within 72?h were randomized 1:1:1 to receive a single intravenous infusion of VIS410 4000?mg, 2000?mg, or placebo. Neuraminidase inhibitor therapy was prohibited. Treatment-emergent adverse events (TEAEs) were evaluated up to 100?days post-infusion. Influenza symptoms were assessed daily for 10?days using the FLU-PRO tool. Nasopharyngeal virus shedding was assessed by quantitative reverse-transcription PCR (qRT-PCR) and viral culture through Day 7. FINDINGS:Of the 150 patients randomized, 148 received study drug, and 138 were confirmed influenza A positive. Median age was 42?years; median time from symptom onset to treatment was 42?h; 93% had influenza A subtype H3N2. SAFETY:TEAEs, most commonly diarrhea of mild severity, were dose-related, occurring in 55%, 35%, and 24% of the 4000?mg, 2000?mg, and placebo patients, respectively. Two serious adverse events occurred, both in placebo patients. SYMPTOM ANALYSES:Baseline FLU-PRO symptom scores were balanced among groups. Mean scores were lower by Days 3 and 4 in the pooled VIS410 treatment group versus placebo (p?

SUBMITTER: Hershberger E

PROVIDER: S-EPMC6412085 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Safety and efficacy of monoclonal antibody VIS410 in adults with uncomplicated influenza A infection: Results from a randomized, double-blind, phase-2, placebo-controlled study.

Hershberger Ellie E Sloan Susan S Narayan Kristin K Hay Catherine A CA Smith Patrick P Engler Frank F Jeeninga Rienk R Smits Saskia S Trevejo Jose J Shriver Zach Z Oldach David D

EBioMedicine 20190109

<h4>Background</h4>VIS410, a broadly neutralizing monoclonal antibody that binds the hemagglutinin stem of influenza A viruses, was safe and efficacious in a human H1N1 virus challenge study. This study evaluated the safety and tolerability of VIS410 in non-hospitalized adult patients with uncomplicated influenza A.<h4>Methods</h4>Patients 18 to 65 years of age with symptom onset within 72 h were randomized 1:1:1 to receive a single intravenous infusion of VIS410 4000 mg, 2000 mg, or placebo. Ne ...[more]

PMID: 30638863

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Dataset Information

Safety and efficacy of monoclonal antibody VIS410 in adults with uncomplicated influenza A infection: Results from a randomized, double-blind, phase-2, placebo-controlled study.

Publications

Safety and efficacy of monoclonal antibody VIS410 in adults with uncomplicated influenza A infection: Results from a randomized, double-blind, phase-2, placebo-controlled study.

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