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Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults

Primary Purpose

Gastroenteritis

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HIL-214
Sponsored by
HilleVax
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastroenteritis

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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 dates a written, informed consent form and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to regulatory requirements. Individuals willing and able to comply with trial procedures and are available for the duration of follow-up. Exclusion Criteria: Females who are pregnant or breastfeeding. Gastroenteritis within 14 days before planned dosing (can warrant delay of trial vaccine administration). Known hypersensitivity or allergy to any of the HIL-214 components (including excipients). Known or suspected impairment/alteration of immune function, including history of any autoimmune disease or neuro-inflammatory disease. Any serious chronic or progressive disease (including hepatitis B or C). Previous exposure to an experimental norovirus vaccine. Subject or subject's first-degree relatives are involved in the trial conduct.

Sites / Locations

  • Pennisula Research Associates
  • Clinical Research Atlanta

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Arm Study

Arm Description

One dose given to all participants

Outcomes

Primary Outcome Measures

Primary Immunogenicity for Panel Formation
For the 80 subjects enrolled in the trial, the serum samples that will be collected will be used to produce a proficient assay panel based on immunogenicity results of the initial testing. This panel that is formed will be used for further analysis in other clinical trials.

Secondary Outcome Measures

Full Information

First Posted
July 11, 2023
Last Updated
August 22, 2023
Sponsor
HilleVax
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1. Study Identification

Unique Protocol Identification Number
NCT05972733
Brief Title
Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults
Official Title
Phase 2, Single-arm, Open-label Trial for Serologic Assay Validation, Proficiency Testing, Safety and Immunogenicity of the Intramuscular HIL-214 Norovirus Vaccine in Adults Aged 18 to 49 Years
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2, 2023 (Actual)
Primary Completion Date
August 14, 2023 (Actual)
Study Completion Date
November 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HilleVax

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this trial is to obtain serum for proficiency testing to confirm assay validity is maintained following the dosing of adults with a pediatric dose of HIL-214.
Detailed Description
This single-arm trial serves to obtain serum for proficiency testing to confirm assay validity is maintained. Exploratory aspects of this trial include evaluating additional assays used for the assessment of immune responses to HIL-214 in peripheral-blood samples. Given the large volume of blood required, the pediatric dose will be tested in healthy adults. The main scientific rationale for the trial is to identify immune assays that can assess the generation of serum antibodies or cell-mediated immunity (CMI) specific to norovirus strains not represented in the HIL-214 vaccine (i.e. cross-reactivity).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroenteritis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Single-arm, Open-label Trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Arm Study
Arm Type
Experimental
Arm Description
One dose given to all participants
Intervention Type
Biological
Intervention Name(s)
HIL-214
Intervention Description
HIL-214
Primary Outcome Measure Information:
Title
Primary Immunogenicity for Panel Formation
Description
For the 80 subjects enrolled in the trial, the serum samples that will be collected will be used to produce a proficient assay panel based on immunogenicity results of the initial testing. This panel that is formed will be used for further analysis in other clinical trials.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 dates a written, informed consent form and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to regulatory requirements. Individuals willing and able to comply with trial procedures and are available for the duration of follow-up. Exclusion Criteria: Females who are pregnant or breastfeeding. Gastroenteritis within 14 days before planned dosing (can warrant delay of trial vaccine administration). Known hypersensitivity or allergy to any of the HIL-214 components (including excipients). Known or suspected impairment/alteration of immune function, including history of any autoimmune disease or neuro-inflammatory disease. Any serious chronic or progressive disease (including hepatitis B or C). Previous exposure to an experimental norovirus vaccine. Subject or subject's first-degree relatives are involved in the trial conduct.
Facility Information:
Facility Name
Pennisula Research Associates
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults

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