Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HIL-214 · 3 trials · 1 indication
Serum samples were obtained for validation of the norovirus GI.1 and GII.4c histoblood group antigen (HBGA)-blocking and total immunoglobulin (pan-Ig) assays. The percentage of participants with a predefined seroresponse (≥4-fold rise in antibody concentration from Day 1 to Day 29) to the GI.1 and GII.4c components of HIL-214 and 95% confidence interval are reported.
Evaluate the immune response to the licensed pediatric DTaP-Hib-IPV-HepB vaccine co-administered with a 2-dose regimen of HIL-214 at 4 and 6 months of age, compared to that of the routine pediatric vaccine co-administered with placebo. Due to differing local availability of licensed DTaP-Hib-IPV-HepB vaccine, data are presented by country (Panama and USA). Outcome measures: * Binary (yes/no) variable indicating anti-DT immunoglobulin G (IgG) concentration ≥0.1 IU/mL. * Binary variable indicating anti-TT IgG concentration ≥0.1 IU/mL. * Anti-pertussis \[FHA\], \[PRN\] and \[PTX\]) IgG concentrations. * Binary variable indicating anti-poliovirus neutralizing antibody titers ≥1:8, * Binary variable indicating anti-Haemophilus influenzae type b * Binary variable indicating anti-hepatitis b surface antigen Geometric mean (geometric mean standard deviation) anti-FHA, anti-PRN, and anti-PTX are presented as a separate outcome.
The outcome was assessed using measurements of immune response to the concomitant anti-pneumococcal capsular polysaccharide IgG \[serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, 18C, and 23F\]) at 28 days post-dose. Geometric mean concentrations are presented.
This outcome was assessed using measurements of immune response to the concomitant RV1 vaccine (anti-RV1 IgA). Geometric mean concentrations at 28 days post-dose 2 are reported.
Percentage of Participants with Adverse Events (AEs) Leading to Trial Withdrawal
Percentage of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days of Vaccine Administration (any dose). Assessed AEs included pain, erythema, induration, and swelling.
Percentage of Participants with Solicited Systemic Adverse Events (AEs) Within 7 Days of Vaccine Administration. Assessed AEs included drowsiness, irritability/fussiness, loss of appetite, fever, vomiting, and diarrhea.
Percentage of participants with AEs that lead to withdrawal of trial vaccine up to the planned time of second dose administration.
| Arm | Type | Description |
|---|---|---|
| Open Arm Study | EXPERIMENTAL | One dose given to all participants |
| Experimental | EXPERIMENTAL | HIL-214 (1 dose at 4 months of age and 1 dose at 6 months of age) and routine childhood vaccines according to schedule. |
| Placebo | PLACEBO_COMPARATOR | Placebo (1 dose at 4 months of age and 1 dose at 6 months of age) and routine childhood vaccines according to schedule. |
| Name | Type | Description |
|---|---|---|
| HIL-214 | BIOLOGICAL | HIL-214 |
| Placebo | BIOLOGICAL | 2 injections - given at 4 months and the second at 6 months of age. |
Inclusion Criteria: * Male or female subjects aged 18 to 49 years, inclusive. * Individuals who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator. * The individual signs and...
HIL-214 is an investigational monoclonal antibody being developed for gastroenteritis. It is currently in Phase 2 clinical development and has been studied in healthy volunteers, including infants and adults, to evaluate its safety and immunogenicity.
HIL-214 is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate the drug's safety and immunogenicity for gastroenteritis.
HIL-214 is in Phase 2 clinical development. It is investigational and not yet approved. Clinical trials have been completed, including a Phase 2 study with 329 participants and a Phase 1 study with 21 participants.
HIL-214 has been studied in three completed trials. NCT05836012 evaluated safety and immunogenicity with routine pediatric vaccines in 329 participants. NCT05972733 validated serologic assays in 80 adults. NCT06007781 assessed safety and immunogenicity in 21 healthy Japanese infants.
HIL-214 is a monoclonal antibody, but its specific molecular target has not been disclosed. It is being studied for its ability to generate an immune response against gastroenteritis, as measured by safety and immunogenicity outcomes in clinical trials.