HIL-214 / Takeda, HilleVax - LARVOL DELTA

Efficacy and Safety of Two Doses of HIL-214 in Children (clinicaltrials.gov) - P2/3 | N=3084 | Terminated | Sponsor: HilleVax | Active, not recruiting ➔ Terminated; Lack of efficacy

Trial termination • Gastroenterology • Gastrointestinal Disorder

Safety and Immunogenicity of HIL-214 in Healthy Japanese Infants (clinicaltrials.gov) - P1 | N=21 | Completed | Sponsor: HilleVax | Active, not recruiting ➔ Completed | Trial completion date: Jun 2025 ➔ May 2024 | Trial primary completion date: Sep 2024 ➔ May 2024

Trial completion • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder

Optimization of a 6-plex Crystal Digital PCR® assay and its application to simultaneous surveillance of enteric and respiratory viruses in wastewater. (PubMed, Sci Total Environ) - "However, no positive correlations were observed for RSV and COVID-19, possibly due to the testing of RSVB while RSVA was more prevalent and also due to cluster outbreaks. These findings demonstrated the utility of the 6-plex cdPCR assay in detecting pathogens and provided insights into community disease trends, representing an advancement in WBE."

Journal • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Persistence of the Immune Response to an Intramuscular Bivalent (GI.1/GII.4) Norovirus Vaccine in Adults. (PubMed, Vaccines (Basel)) - "Immune responses to HIL-214 in adults appear to persist for five years."

Journal • Gastroenterology • Gastrointestinal Disorder

Safety and immunogenicity of a bivalent norovirus vaccine candidate in infants from 6 weeks to 5 months of age: A phase 2, randomized, double-blind trial. (PubMed, Hum Vaccin Immunother) - "Two doses of each formulation induced high titers of high avidity Pan-Ig and also HBGA antibodies; a third dose increased titers against both antigens and the avidity of Pan-Ig antibodies against GII.4c but not against GI.1. Two and three doses of HIL-214 were well-tolerated and induced potent immune responses at 4-6 months of age supporting further clinical assessment to protect against norovirus-related AGE."

Clinical • Journal • P2 data • Gastroenterology • Gastrointestinal Disorder • Pain

Epidemiology of norovirus disease in the first two years of life: a prospective multisite cohort study in Lima, Peru. (PubMed, Int J Infect Dis) - "Norovirus was the second most frequent cause of AGE in this Peruvian cohort with high rotavirus vaccine coverage. An effective norovirus vaccine would have an important public health benefit in this population."

Journal • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Pediatrics • Rotavirus Infections

Chemical constituents of five Saxifraga species and their virucidal activities. (PubMed, Fitoterapia) - "The virucidal activities of the isolated compounds (1-30) against influenza A virus, severe acute respiratory syndrome coronavirus 2, feline calicivirus, and murine norovirus were evaluated to identify the presence of compounds other than the Saxifraga species-derived tannins, which exhibited virucidal activities. Although the isolated compound activities were relatively weak compared to those of Saxifraga species-derived tannins, the potential virucidal activity of the compounds with galloyl groups was confirmed."

Journal • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity of HIL-214 With Routine Pediatric Vaccines (clinicaltrials.gov) - P2/3 | N=371 | Completed | Sponsor: HilleVax | Active, not recruiting ➔ Completed

Trial completion • Gastroenterology • Gastrointestinal Disorder • Pediatrics

Beyond COVID-19: Wastewater-based epidemiology for multipathogen surveillance and normalization strategies. (PubMed, Sci Total Environ) - "Turbidity normalization also yielded suboptimal results. This study underscored the importance of selecting suitable normalization parameters tailored to specific pathogens for accurate disease trend monitoring using WBE, demonstrating its utility beyond COVID-19 surveillance."

Journal • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

GI.1 Norovirus Neutralizing Antibody Levels Are Correlated with GI.1 Histo-blood Group Antigen-Blocking Antibody Levels. (PubMed, J Infect Dis) - "GI.1-specific HBGA-blocking antibodies are a surrogate for neutralization of GI.1 norovirus."

Journal

Efficacy and Safety of Two Doses of HIL-214 in Children (clinicaltrials.gov) - P2/3 | N=3085 | Active, not recruiting | Sponsor: HilleVax | Trial completion date: Jan 2024 ➔ Dec 2024

Trial completion date • Gastroenterology • Gastrointestinal Disorder

Norovirus in children under 2 years of age: an epidemiological study in Panama during the COVID-19 pandemic. (PubMed, Front Pediatr) - "This report demonstrates how the occurrence of the COVID-19 pandemic hindered the conduct of clinical trials. However, this also created unique research opportunities to investigate the potential impact of pandemic control measures on the etiology of infectious diarrheal disease."

Journal • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Evaluating acute gastroenteritis-causing pathogen reduction in wastewater and the applicability of river water for wastewater-based epidemiology in the Kathmandu Valley, Nepal. (PubMed, Sci Total Environ) - "Insufficient treatment of all pathogens in the wastewater was observed suggesting the need for full rehabilitation of the treatment plants. However, the influent may be utilized for early detection of AGE-causing pathogens in the city, whereas the river water may serve as an alternative in areas without connection to the WWTPs."

Journal • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Influenza • Respiratory Diseases

Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults (clinicaltrials.gov) - P2 | N=80 | Completed | Sponsor: HilleVax | Active, not recruiting ➔ Completed

Trial completion • Gastroenterology • Gastrointestinal Disorder

Efficacy and Safety of Two Doses of HIL-214 in Children (clinicaltrials.gov) - P2/3 | N=3085 | Active, not recruiting | Sponsor: HilleVax | Phase classification: P2b ➔ P2/3 | Trial completion date: Jun 2024 ➔ Jan 2024

Phase classification • Trial completion date • Gastroenterology • Gastrointestinal Disorder

Optimization of the 5-plex digital PCR workflow for simultaneous monitoring of SARS-CoV-2 and other pathogenic viruses in wastewater. (PubMed, Sci Total Environ) - "SARS-CoV-2 RNA was detected in the majority of samples, with NoV-GI, NoV-GII, and EnV also being detected. The successful optimization and application of the 5-plex dPCR assay for pathogen surveillance in wastewater offers significant benefits, including enhanced community health assessment and more effective responses to public health threats."

Journal • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity of HIL-214 in Healthy Japanese Infants (clinicaltrials.gov) - P1 | N=21 | Active, not recruiting | Sponsor: HilleVax | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastrointestinal Disorder

A Bivalent Human Norovirus Vaccine Induces Homotypic and Heterotypic Neutralizing Antibodies. (PubMed, J Infect Dis) - "A GII.2 outbreak in an efficacy study of a bivalent virus-like particle (VLP) norovirus vaccine, TAK-214, in healthy US adults provided an opportunity to examine GII.4 homotypic vs. GII.2 heterotypic responses to vaccination and infection...Although the vaccine provided protection from GII.2-associated disease, little GII.2-specific neutralization occurred after vaccination. Choice of antibody assay can affect assessments of human norovirus vaccine immunogenicity."

Journal • Infectious Disease

Safety and Immunogenicity of HIL-214 With Routine Pediatric Vaccines (clinicaltrials.gov) - P2/3 | N=400 | Active, not recruiting | Sponsor: HilleVax | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Pediatrics

Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults (clinicaltrials.gov) - P2 | N=80 | Active, not recruiting | Sponsor: HilleVax | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastrointestinal Disorder

Safety and Immunogenicity of HIL-214 in Healthy Japanese Infants (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: HilleVax

New P1 trial • Gastroenterology • Gastrointestinal Disorder

Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: HilleVax | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder

Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: HilleVax

New P2 trial • Gastroenterology • Gastrointestinal Disorder

Safety and Immunogenicity of HIL-214 With Routine Pediatric Vaccines (clinicaltrials.gov) - P2/3 | N=400 | Recruiting | Sponsor: HilleVax | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Pediatrics

"if I were Carnival I would simply fund the phase 3 trials of TAK-214 vaccine candidate" (@Kaelberviridae)

Clinical • P3 data