Safety and Immunogenicity of HIL-214 With Routine Pediatric Vaccines

NCT05836012 | Completed Phase 2 Results FDA Drug

• 1 other identifier: NOR-206
• Study Type: interventional
• Target: 329
• Locations: 3 countries
• Sites: 12

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.

Conditions

Gastroenteritis

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  28 days post-dose 2

• 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.

  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 concentrations

  28 days post-dose 2

• Immune 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.

  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.

  28 days post-dose 2

• 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.

  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.

  28 days post-dose 2

Secondary Outcomes (5)

• 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

• 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 Day 7 post-dose 1 and Day 1 to Day 7 post-dose 2

• 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 Day 7 post-dose 1 and Day 1 to Day 7 post-dose 2

• 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

• 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

Study Arms (2)

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.

Biological: HIL-214

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.

Biological: Placebo

Interventions

HIL-214 BIOLOGICAL

2 injections - given at 4 months and the second at 6 months of age.

Experimental

Placebo BIOLOGICAL

2 injections - given at 4 months and the second at 6 months of age.

Placebo

Eligibility Criteria

• Age: 2 Months - 2 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Clinically significant abnormality in growth by height, weight, or head circumference (according to local guidelines).
• Gastrointestinal abnormalities or any chronic gastrointestinal disease, including any uncorrected congenital malformation of the gastrointestinal tract according to medical history and/or physical examination.
• Known hypersensitivity or allergy to any of the investigational vaccine components (including excipients).
• Severe reaction to routine childhood vaccine(s) administered at Visit 1.
• 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.
• Any serious chronic or progressive disease according to the judgment of the investigator (e.g., cardiac, renal or hepatic disease).
• 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.
• Known or suspected impairment/alteration of immune function.
• Subjects with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
• 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.
• 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.
• Subjects known to be positive for or in evaluation for possible human immunodeficiency virus infection.
• Subject's LAR or subject's first-degree relatives involved in the trial conduct.

Sponsors & Collaborators

• HilleVax: lead

Study Sites (12)

Velocity Clinical Research - Lafayette

Lafayette, Louisiana, 70508, United States

Location

Boeson Research MSO

Missoula, Montana, 59804, United States

Location

Velocity Clinical Research - Hastings

Hastings, Nebraska, 68901, United States

Location

Frontier Pediatric Care

Lincoln, Nebraska, 68516, United States

Location

La Providence Pediatrics Clinic - Chemidox Clinical Trials (Hypercore)

Houston, Texas, 77071, United States

Location

Alliance for Multispecialty Research LLC - Kaysville

Kaysville, Utah, 84037, United States

Location

Alliance for Multispecialty Research LLC - Syracuse

Syracuse, Utah, 84075, United States

Location

CEVAXIN-La Chorrera

La Chorrera, Panama

Location

Cervaxin-Avenida Mexico

Panama City, Panama

Location

Cervaxin-Tocumen

Panama City, Panama

Location

BRCR Global

San Juan, 00907, Puerto Rico

Location

HACTR

San Juan, 00936, Puerto Rico

Location

MeSH Terms

Conditions

Gastroenteritis

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Astrid Borkowski, Chief Medical Officer
• Organization: HilleVax, Inc.

aborkowski@hillevax.com

+1 (617) 213-6562

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: May 1, 2023
• Study Start: June 10, 2023
• Primary Completion: January 19, 2024
• Study Completion: July 8, 2024
• Last Updated: March 12, 2025
• Results First Posted: March 12, 2025

Record last verified: 2024-12

Locations

PR (2); US (7); PA (3)