Norovirus Vaccine Candidate Launches Phase 1 Study With Lactating Mothers

Vaxart, Inc. today announced it has dosed the first subject in its Phase 1 clinical trial evaluating Vaxart’s oral pill bivalent norovirus vaccine candidate (VXA-G1.1-NN) focused on lactating mothers.

This new study is evaluating the ability of oral vaccine tablets to induce breast milk antibodies and transfer antibodies to infants.

Norovirus sickens approximately 21 million people in the U.S. annually, including 15% of children under age 5. While pediatric deaths due to norovirus in the U.S. are rare, they are much more common in the developing world.

Currently, there are no U.S. FDA-approved norovirus vaccines.

The Phase 1, multicenter, randomized, double-blind, placebo-controlled, single-dose, dose-ranging VXA-NVV-108 Clinical Trial is designed to evaluate the safety, tolerability, and immunogenicity of orally administered bivalent GI.1/GII.4 norovirus vaccine in healthy lactating females at least 18 years of age and their breast-feeding infants (aged 30 days to 11 months).

The study is expected to enroll approximately 76 subjects at seven sites in South Africa.

“Initiating this study is an important step toward Vaxart’s goal of developing a vaccine that may reduce the significant global health threat norovirus poses to children under five years of age,” said Dr. James F. Cummings, Vaxart’s chief medical officer in a press release on November 2, 2023.

“We believe an oral norovirus vaccine pill may one day allow mothers to protect their infants against this highly contagious virus for which there currently is no approved vaccine.”

The Phase 2b study (VXA-NVV-201) is expected to add safety data that, if successful, could enable Vaxart to schedule an End-of-Phase 2 meeting with the U.S. FDA, potentially in 2024.

Vaxart believes that its proprietary pill vaccine delivery platform is suitable for delivering recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications.