Oral Norovirus Vaccine Progresses in Phase 2 Study

Vaxart, Inc. today announced that it had dosed the first subject in a Phase 2 dose-ranging clinical trial of its oral tablet bivalent vaccine candidate.

Vaxart expects to report topline data from the Phase 2 study in mid-2023.

"Initiating the Phase 2 clinical trial of this candidate is an important achievement toward our goal of developing an oral tablet vaccine that may reduce the significant global health threat that norovirus poses to children and seniors," said Dr. James F. Cummings, MD, Chief Medical Officer at Vaxart, in a press release on February 14, 2023.

"Results from the Phase 1b clinical trial in healthy adults demonstrate that this candidate stimulates robust IgA antibody-secreting cells against the prevalent strains of two norovirus genotypes that cause most norovirus disease."

"Data from the Phase 2 trial will inform our further clinical development strategy for this promising vaccine candidate."

As previously reported, Vaxart's bivalent vaccine candidate demonstrated robust immunogenicity, with an IgA ASC response rate of 78% for the GI.1 strain and 93% for the GII.4 strain, with no interference observed.

Three Phase 1 studies of Vaxart's norovirus pill vaccine indicated it is well tolerated and generated systemic and local immune responses that are both robust and persistent. 

In the U.S., norovirus causes 21 million illnesses each year, infecting 15% of all children under the age of five years and resulting in illness — which frequently requires hospitalization — in 7.5% of people over 65 years.

Other norovirus vaccine candidate news is posted at PrecisionVaccinations.