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NCT05281094 (HIL-214 in Norovirus): BVCT ex-ante prediction vs. reported outcome

On 14 Feb 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 8 Jul 2024 readout is classified on the dashboard as False Positive (FP), a missed prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05281094
Acronym
NEST-IN1
Drug Name
HIL-214
Drug MoA
norovirus bivalent GI.1/GII/4 VLP vaccine
Drug Modality
virus-like particle vaccine
Drug Class
First-In-Class
Therapeutic Area
Infections
Indication
Norovirus
Human Patients
3085
Sponsor
HilleVax
Phase
Phase 2 Phase 3

Prediction of , index 396

Prospective Prediction
Prediction Index
396
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
145 days in advance
Readout Data Interpretation
endpoints not met.
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal disease model of norovirus that has been permanently corrected.
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
False Positive (FP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 2b, Double-blind, Randomized, Multi-site, Placebo-controlled Trial to Evaluate the Efficacy, Safety and Immunogenicity of Intramuscular HIL-214 Norovirus Vaccine in Healthy Children 5 Months of Age at Initial Vaccination
Phase
Phase 2, Phase 3
Status
Terminated
Enrollment
3084
Lead sponsor
HilleVax
Conditions
Gastroenteritis
Interventions
BIOLOGICAL: HIL-214; BIOLOGICAL: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Prevention
Start
2022-04-28
Primary completion
2023-12-28
Completion
2024-09-30
Results first posted
2025-07-10
Primary outcomes
  • To Demonstrate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated Only With GI.1 or GII.4 Norovirus Genotypes. (The duration of the primary observation period was 6 months starting at 28 days post dose 2.)

NCT05281094 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials