Clinical trial NCT06289868: Access Anti-HAV and Access Anti-HAV IgM Assays EU Clinical Trial Protocol (HAV-EU-11-23)
Official title: Evaluation of the Access Anti-HAV and Access Anti-HAV IgM Assays As an Aid in the Diagnosis of HAV Infection, and for Detection of Anti-HAV After Vaccination: EU Clinical Trial Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HAV
Keywords: Hepatitis A Virus (HAV)
IgM antibody to Hepatitis A Virus (HAV IgM)
antibody to Hepatitis A Virus
Lead sponsor: Beckman Coulter, Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-04
Enrollment: 1409
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population is the hepatitis A infection diagnostic population, and pre- and post-HAV vaccinated patients for Access anti-HAV assay only.

Population will include approximately 1,030 subjects as follows:

* ≥ 930 samples from adult and pediatric patients were collected as part of the US HAV trial prospective and retrospective sample enrollment :

  * From subjects exhibiting either jaundice or elevated bilirubin or elevated serum ALT enzymes and one or more primary signs and symptoms of hepatitis infection, and/or
  * From subjects at-risk of HAV infection, and/or
  * From subjects for whom laboratory testing for hepatitis A was ordered by their healthcare providers.
* ≥ 100 retrospective known anti-HAV IgM positive samples.

In addition, for the Access anti-HAV assay only, at least 60 subjects from the US vaccination study will be tested pre and post vaccination in this EU HAV assay clinical trial.

Brief summary: The purpose of this study is to evaluate the clinical performance supporting that intended purpose of the Access anti-HAV as an aid in the laboratory diagnosis of HAV infection and for detection of anti-HAV after vaccination and of the Access anti-HAV IgM assay as an aid in the laboratory diagnosis of acute or recent HAV infection, on the DxI 9000 Access Immunoassay Analyzer.

This study will be used to obtain CE mark for both Access anti-HAV and anti- HAV IgM assays.

Detailed description: The objective of this study is to determine the diagnostic accuracy of Access anti-HAV and Access anti-HAV IgM assays on the DxI 9000 Access Immunoassay Analyzer, measured as clinical sensitivity and specificity.

The testing will be performed using banked, de-identified, prospective and retrospective US leftover clinical samples, and fully-anonymized retrospective known anti-HAV IgM positive patient samples procured from sample vendors.

Eligibility criteria: Inclusion Criteria:

Subject inclusion criteria for the signs and symptoms (S/S), at risk (A/R), HAV test ordered, and Acute HAV Infection cohorts:

* Subjects ≥ 2 years of age
* Subject or legal guardian has signed the Informed Consent Form (ICF) (a minor may need to sign an Assent Form (AF) if required by IRB)
* Subjects who are willing to donate the required amount of blood
* Subjects qualified for one (1) or more of the following four (4) Cohorts:

  * Signs and symptoms (S/S);
  * At risk (A/R);
  * Presumed S/S or A/R (HAV test ordered) and
  * Acute HAV Infection (known anti-HAV IgM positive samples) - these samples are not subject to the individual informed consent and volume criteria.

Subject inclusion criteria for the vaccination cohort

* Subjects 2 years of age or older
* Subjects able to understand and willing to sign the ICF at both pre and post vaccination time points. Subject or legal guardian has signed the Informed Consent Form (a minor may need to sign an assent form if required by IRB)
* Subjects who are willing to donate the required amount of blood: 30 mL
* Subjects with no signs or symptoms of hepatitis as determined by a medical provider, no history of known exposure to HAV
* Subjects previously unvaccinated for HAV

Exclusion Criteria:

* Subjects who previously participated in the study
* Subjects who have received experimental or investigational drugs or treatments within four weeks of phlebotomy

Note for vaccination study: Subjects were screened for anti-HAV prior to vaccination, if positive they were excluded from the study.

Primary outcomes:
measure: Access Anti-HAV diagnostic accuracy measured as sensitivity and specificity
timeFrame: Baseline
measure: Access Anti-HAV IgM diagnostic accuracy measured as sensitivity and specificity
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Frepillon
country: France
facility: Cerba Xpert
city: Ivry-sur-Seine
country: France
facility: Eurofins Biomnis
Study officials:
References: