HilleVax’s norovirus vaccine ineffective in large trial of infants

HilleVax’s norovirus vaccine ineffective in large trial of infants

Dive Brief:

  • Biotechnology company HilleVax on Monday said it will halt development  of an experimental norovirus vaccine in infants after the shot proved ineffective in a large trial, sending shares sliding.
  • HilleVax’s candidate, dubbed HIL-214, failed to meet its primary or secondary goals in the Phase 2b study, which tested its ability to prevent moderate or severe norovirus-related acute gastroenteritis.
  • There is no vaccine for norovirus, and HilleVax’s candidate was the farthest along in clinical development, according to the company. While development in infants is now discontinued, the Boston company said it is “exploring the potential” to continue testing HIL-214 or another candidate called HIL-216 in adults.

Dive Insight:

According to the Centers for Disease Control and Prevention, norovirus is the leading cause of foodborne illness, vomiting and diarrhea. Outbreaks occur when infected people make direct contact with other individuals. Contact with contaminated food, water and surfaces can also lead to infection.

Norovirus outbreaks commonly occur in healthcare facilities, as well as in schools and childcare centers. Children younger than 5 years, as well as older adults or people who are immunocompromised are at higher risk of severe infection.

HilleVax has sold investors on the promise of its vaccine being first to a market it estimates to be worth multiple billions of dollars. The company prioritized seeking approval in infants first, although it has been considering the adult market as well.

The Phase 2b study, dubbed NEST-IN1, was a randomized, placebo-controlled trial of more than 3,000 healthy infants in the U.S. and Latin America. Results showed that vaccine efficacy against moderate or severe acute gastroenteritis was only 5%, with 25 cases in the vaccine arm and 26 cases in the placebo group.

“While HIL-214 previously showed clinical benefit in adults, NEST-IN1 was the first efficacy study conducted in infants for a norovirus vaccine candidate,” Rob Hershberg, CEO of HilleVax, said in a statement. “We believe the efficacy in the infant setting may have been impacted by the appearance of multiple emerging GII.4 strains in this trial.”

The company said HIL-214’s safety and immune response profile was consistent with prior testing.

HilleVax was launched in 2021 by Takeda Pharmaceuticals and Frazier Healthcare Partners with a license to what was then Takeda’s norovirus vaccine candidate.


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