FluGen has announced that a Phase 1b age de-escalation clinical trial of its M2SR intranasal live virus flu vaccine has completed enrollment of the first cohort, which includes children aged 9-17. The study will subsequently evaluate the monovalent Singapore 2016 H3N2 M2SR influenza A vaccine in a cohort of children aged 2-8 and then in children aged 6-23 months, with a total of 220 volunteers taking part. Subjects will receive one or two doses of vaccine or intranasal placebo.
According to FluGen, the pediatric study is funded by the National Institute of Allergy and Infectious Diseases (NIAID) Collaborative Influenza Vaccine Innovation Centers (CIVICs) program. Earlier this year, the company announced the initiation of a Phase 1b study of M2SR intranasal vaccine in older adults; that study is funded by the US Department of Defense.
FluGen President and CEO Paul Radspinner commented, “The rate of influenza infection is highest in pediatric patients, and the current standard-of-care does not meet the needs of this unprotected population. We are pleased that the NIH has selected our M2SR flu vaccine candidate to be studied as part of its CIVICs program, and look forward to sharing further updates, and the initial results of the study, which are expected in the first half of 2023.”
Read the FluGen press release.
