NCT05836012

Safety and Immunogenicity of HIL-214 With Routine Pediatric Vaccines

A Phase 2, Multi-country, Randomized, Double-blind, Placebo-controlled Trial to Evaluate Safety and Immunogenicity When HIL-214 is Concomitantly Administered With Routine Pediatric Vaccines in Healthy Infants

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 329 (actual)
• Sponsor: HilleVax · Industry
• Sex: All
• Age: 2 Months – 2 Months
• Healthy volunteers: Accepted

Summary

This is a phase 2, multi-country, randomized, double-blind, placebo-controlled trial to evaluate the immune response to routine pediatric vaccinations when co-administered with HIL-214 or placebo in healthy infants. This trial will also evaluate the safety profile of a 2-dose regimen of HIL-214 co-administered with routine pediatric vaccines.

Detailed description

Epidemiologic studies have shown that gastroenteritis in infants is associated with several viruses, including norovirus, sapovirus and rotavirus. These viruses together or individually can be associated with illness ranging from asymptomatic to serious. Asymptomatic infection can create a reservoir, allowing further spread of the virus, whereas serious illness can lead to death, particularly in the very young, very old or immunocompromised. As the burden of rotavirus in children decreases due to successful rotavirus vaccination programs in infants, norovirus infections are increasingly recognized as the primary cause of acute gastroenteritis (AGE) in many countries around the world. Currently, there is no available vaccine to counter the disease burden associated with norovirus. Vaccinating at an early age would reduce the severe illness in young children and also reduce the asymptomatic cases which act as a vehicle for transmission within the population. As infants already receive multiple vaccines during the first months of life, an additional vaccination must fit into the immunization scheme in a convenient way for compliance. It must also have an acceptable safety profile and be immunogenic without interfering with the immune response to routine childhood vaccines.

Conditions

• Gastroenteritis

Interventions

Type	Name	Description
BIOLOGICAL	HIL-214	2 injections - given at 4 months and the second at 6 months of age.
BIOLOGICAL	Placebo	2 injections - given at 4 months and the second at 6 months of age.

Timeline

• Start date: 2023-06-10
• Primary completion: 2024-01-19
• Completion: 2024-07-08
• First posted: 2023-05-01
• Last updated: 2025-03-12
• Results posted: 2025-03-12

Locations

12 sites across 3 countries: United States, Panama, Puerto Rico

Regulatory

• FDA-regulated drug study