Safety and Immunogenicity of HIL-214 With Routine Pediatric Vaccines
- Registration Number
- NCT05836012
- Lead Sponsor
- HilleVax
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 329
- The subject is aged 2 months (+14 days).
- Male or female.
- Infants 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 subject's LAR signs and dates a written, informed consent form (ICF) and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.
- Infants whose LARs can and are willing to comply with trial procedures and are available for the duration of follow-up.
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Clinically significant abnormality in growth by height, weight, or head circumference (according to local guidelines).
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Gastrointestinal abnormalities or any chronic gastrointestinal disease, including any uncorrected congenital malformation of the gastrointestinal tract according to medical history and/or physical examination.
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Known hypersensitivity or allergy to any of the investigational vaccine components (including excipients).
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Severe reaction to routine childhood vaccine(s) administered at Visit 1.
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Any clinically significant active infection (as assessed by the investigator) or temperature
≥38.0°C (>100.4°F), within 3 days of intended trial vaccination.
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Any serious chronic or progressive disease according to the judgment of the investigator (e.g., cardiac, renal or hepatic disease).
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Individuals with history of, e.g., convulsions/febrile convulsions, or any illness, that, in the opinion of the investigator, might interfere with the results of the trial or pose additional risk to the subjects due to participation in the trial.
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Known or suspected impairment/alteration of immune function.
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Subjects with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
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Subjects who received or are scheduled to receive any licensed or authorized vaccines not planned in this trial within 14 days (for inactivated vaccines) or within 28 days (for live vaccines) before or after any dose of trial vaccine. Note: Flu and/or COVID vaccine can be administered per local guidelines at any time during the trial.
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Subjects participating in any clinical trial with another investigational product 30 days prior to first trial visit or due to participate in another clinical trial at any time during the conduct of this trial.
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Subjects known to be positive for or in evaluation for possible human immunodeficiency virus infection.
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Subject's LAR or subject's first-degree relatives involved in the trial conduct.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental HIL-214 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 Placebo (1 dose at 4 months of age and 1 dose at 6 months of age) and routine childhood vaccines according to schedule.
- Primary Outcome Measures
Name Time Method 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 Vaccines Co-administered With Placebo. 28 days post-dose 2 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:
Geometric mean anti-FHA, anti-PRN, and anti-PTX concentrationsImmune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) 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 Vaccines Co-administered With Placebo. 28 days post-dose 2 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.
Immune Response to the Licensed Pediatric Rotavirus Vaccine (RV1) 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 Vaccines Co-administered With Placebo. 28 days post-dose 2 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.
- Secondary Outcome Measures
Name Time Method Immunogenicity of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age. Pre-dose 1 and 28 days post-dose 2 Anti-norovirus (GI.1 and GII.4c) HBGA-blocking antibodies were measured at prior to dose 1 (\~4 months of age) and 28 days post-dose 2 (\~6 months of age). Seroresponse was defined as a fold increase from baseline greater than or equal to 4. Seroresponse rates and 95% confidence intervals (CIs) are presented. Data are stratified by country (Panama and USA).
Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. Day 1 to 28 days post-dose 1 (vaccine discontinuation); Day 1 to 12 months post-dose 1 Percentage of participants with adverse events (AEs) leading to vaccine discontinuation or trial withdrawal.
Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo Day 1 to 12 months post-dose 1 Percentage of participants with medically attended adverse events (AEs) at any point during the trial.
Trial Locations
- Locations (12)
Velocity Clinical Research - Lafayette
🇺🇸Lafayette, Louisiana, United States
Boeson Research MSO
🇺🇸Missoula, Montana, United States
Velocity Clinical Research - Hastings
🇺🇸Hastings, Nebraska, United States
La Providence Pediatrics Clinic - Chemidox Clinical Trials (Hypercore)
🇺🇸Houston, Texas, United States
Frontier Pediatric Care
🇺🇸Lincoln, Nebraska, United States
Alliance for Multispecialty Research LLC - Kaysville
🇺🇸Kaysville, Utah, United States
Alliance for Multispecialty Research LLC - Syracuse
🇺🇸Syracuse, Utah, United States
CEVAXIN-La Chorrera
🇵🇦La Chorrera, Panama
Cervaxin-Avenida Mexico
🇵🇦Panamá City, Panama
Cervaxin-Tocumen
🇵🇦Panama City, Panama
BRCR Global
🇵🇷San Juan, Puerto Rico
HACTR
🇵🇷San Juan, Puerto Rico