Biotechnology firm Vaxart has commenced the dosing of patients in the randomised cohort of a Phase Ib clinical trial of its bivalent norovirus vaccine meant for administration via tablet instead of injection.
The bivalent vaccine is made of oral norovirus GI.1 and GII.4 vaccine tablets administered simultaneously.
The company believes that the tableted formulation of vaccines will enable easy distribution and administration compared to injectable vaccines. The tablet forms are also expected to increase vaccination rates.
During the randomised, double-blind, placebo-controlled, multi-centre trial, the safety and immunogenicity of the bivalent norovirus vaccine will be assessed in around 86 subjects.
It consists of two parts, an open-label lead-in phase, and a randomised, double-blind, placebo-controlled phase. The first part has been completed, and the second portion is now active.
The primary outcomes of the trial are the rate of solicited and unsolicited adverse events, and immunogenicity. Top-line results from the study are expected to be reported in the second half of this year.
Vaxart chief medical officer David Taylor said: “The monovalent GII.4 vaccine tablets performed as expected in the lead-in cohort we just completed, and we look forward to building on the excellent results we observed previously with our monovalent GI.1 vaccine.
“Norovirus is the leading cause of foodborne illness in the US and causes significant morbidity and mortality in older adults and the very young. Our oral norovirus vaccine could provide a significant public health benefit for these vulnerable populations in the US and beyond.”
Apart from norovirus, the company is developing oral tablet vaccines for seasonal influenza and respiratory syncytial virus (RSV). It is also working on a therapeutic vaccine to treat human papillomavirus (HPV).