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VXA-NVV-108 (VAXART)

Projects

VXA-NVV-108 (VAXART)

A phase I, multicenter, randomized, double-blind, placebo-controlled single dose, dose-ranging study to evaluate the safety, tolerability, and immunogenicity of orally administered bivalent GI.1/GII.4 norovirus vaccine in healthy lactating females ≥ 18 years old and their breast-feeding infants.

Rationale

Noroviruses (NoVs) are a diverse group of small RNA viruses that cause acute gastroenteritis, with infants aged 6 to 23 months bearing the highest disease burden. With the global adoption of the rotavirus vaccine, NoV infections have become a prominent cause of infant diarrheal illness. This leads to an estimated 64,000 hospitalizations, 900,000 clinic visits, and up to 200,000 fatalities in children under 5 annually, particularly in developing countries. The pressing need for interventions to curb this contagious disease is evident.

Vaxart’s NoV oral vaccine utilizes a unique non-replicating adenoviral-based platform, proven safe in over 600 healthy adults. Collaborative research between Vaxart and partners demonstrated the vaccine’s ability to induce immunogenicity in lactating ferrets, suggesting a potential for breastmilk antibodies to protect nursing infants from diarrheal disease. This study aims to assess the vaccine’s impact on breastmilk immunogenicity in lactating females and its effect on their infants’ fecal samples.

Investigators

  • Wits RHI
  • Prof. Thesla Palanee-Phillips (Co-Principal Investigator)
  • Dr. Nkosiphile Ndlovu (Co-Investigator)

Latest Update

April 2024

For more details about VXA-NVV-108 (VAXART) please email rhicomms@wrhi.ac.za

Click here for further details regarding the VXA-NVV-108 (VAXART) study.

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