HAVNCT06289868
Access Anti-HAV and Access Anti-HAV IgM Assays EU Clinical Trial Protocol (HAV-EU-11-23)
An observational study of HAV, run by Beckman Coulter, Inc. at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- HAV
- What is being tested?
- Access anti-HAV and Access anti-HAV IgM on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays and Access anti-HAV on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
- Type of treatment
- Vaccines
- How many people
- 1,409 participants
- Where
- 2 sitesFrance
- Study dates
- 27 Feb 2024to 29 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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);
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- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Cerba Xpert
Frépillon, 95740
Eurofins Biomnis
Ivry-sur-Seine, 94208
About this study
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
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.
Read the 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.
- Conditions
- HAV
- Being tested
- Access anti-HAV and Access anti-HAV IgM on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays, Access anti-HAV on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
- Keywords
- Hepatitis A Virus (HAV), IgM antibody to Hepatitis A Virus (HAV IgM), antibody to Hepatitis A Virus
- Medical subject headings
- Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access anti-HAV and Access anti-HAV IgM on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assaysDiagnostic test
Samples will be tested by comparing Access anti-HAV assay results to final anti-HAV sample status, and Access anti-HAV IgM results to final anti-HAV IgM status, according to respective instructions for use (IFU) or study guide, as applicable, to determine to determine non-reactive (NR), reactive (R), Negative, Positive or Equivocal (EQ).
For evaluation of the clinical performance of Access anti-HAV assay, all clinical samples will be tested with the reference assays DiaSorin - LIAISON® Anti-HAV and SIEMENS Healthineers Atellica® IM Hepatitis A Total (aHAVT).
For evaluation of the clinical performance of Access anti-HAV IgM assay, all clinical samples, except pre- and post-vaccinated patient samples, will be tested with the reference assays Abbott - ARCHITECT® HAVAb-IgM, DiaSorin - LIAISON® Anti-HAV IgM, and SIEMENS Healthineers Atellica IM® Hepatitis A IgM (aHAVM).
Access anti-HAV on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assaysDiagnostic test
All samples will be tested pre- and post-vaccination by comparing Access anti-HAV assay results to final anti-HAV status, according to respective instructions for use (IFU) or study guide, as applicable, to determine non-reactive (NR), initial reactivity, and repeat reactivity.
For evaluation of the clinical performance of Access anti-HAV assay, all clinical samples will be tested with the reference assays DiaSorin - LIAISON® Anti-HAV and SIEMENS Healthineers Atellica® IM Hepatitis A Total (aHAVT).
| Study group | Role | What they receive |
|---|---|---|
| At-risk and/or signs and symptoms patients of HAV infection and/or HAV test ordered patients | Frozen leftover serum samples from adult and pediatric patients:
* From subjects exhibiting either jaundice or elevated total 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. Receives: Diagnostic Test: Access anti-HAV and Access anti-HAV IgM on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays | |
| Known anti-HAV IgM positive patients | Frozen serum or EDTA retrospective known anti-HAV IgM positive leftover samples procured from sample vendors .
These samples are known Positive for HAV IgM AND at least one of the following :
* Positive HAV PCR result (within the last 28 days) OR
* Jaundice (clinical assessment OR Total bilirubin result >3.0 mg/dL) OR
* Elevated ALT result (> 200 IU/L) Receives: Diagnostic Test: Access anti-HAV and Access anti-HAV IgM on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays | |
| HAV Pre- and post-vaccinated patients | Frozen serum leftovers. A first sample was collected, and the US licensed and CE-marked vaccination series administered. A second sample was collected four (4) to ten (10) weeks after the complete vaccination series has been administered according to vaccine dosing instructions. Receives: Diagnostic Test: Access anti-HAV on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays |
What is being measured
The primary outcome is the main question the study is designed to answer.
Access Anti-HAV diagnostic accuracy measured as sensitivity and specificity
The endpoints will be diagnostic accuracy measured as clinical sensitivity and specificity of Access anti-HAV assay compared to final anti-HAV status
Measured: Baseline
Access Anti-HAV IgM diagnostic accuracy measured as sensitivity and specificity
The endpoints will be diagnostic accuracy measured as clinical sensitivity and specificity of Access anti-HAV IgM assay compared to final anti-HAV IgM status.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start27 Feb 2024
- Primary completion13 Aug 2024
- Study completion29 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HAVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beckman Coulter, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289868
- Sponsor's protocol ID
- DC-TR23-0222
- Other IDs
- HAV-EU-11-23
- Status last verified
- Dec 2024
- First submitted
- 26 Feb 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06289868
- Acronym / sponsor ID
- DC-TR23-0222
- Conditions
- HAV
- Keywords
- Hepatitis A Virus (HAV), IgM antibody to Hepatitis A Virus (HAV IgM), antibody to Hepatitis A Virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,409 participants (actual)
- Lead sponsor
- Beckman Coulter, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 13 Aug 2024 (actual)
- Study completion
- 29 Aug 2024 (actual)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| At-risk and/or signs and symptoms patients of HAV infection and/or HAV test ordered patients | – | Diagnostic Test: Access anti-HAV and Access anti-HAV IgM on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assaysFrozen leftover serum samples from adult and pediatric patients: * From subjects exhibiting either jaundice or elevated total 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. |
| Known anti-HAV IgM positive patients | – | Diagnostic Test: Access anti-HAV and Access anti-HAV IgM on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assaysFrozen serum or EDTA retrospective known anti-HAV IgM positive leftover samples procured from sample vendors . These samples are known Positive for HAV IgM AND at least one of the following : * Positive HAV PCR result (within the last 28 days) OR * Jaundice (clinical assessment OR Total bilirubin result >3.0 mg/dL) OR * Elevated ALT result (> 200 IU/L) |
| HAV Pre- and post-vaccinated patients | – | Diagnostic Test: Access anti-HAV on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assaysFrozen serum leftovers. A first sample was collected, and the US licensed and CE-marked vaccination series administered. A second sample was collected four (4) to ten (10) weeks after the complete vaccination series has been administered according to vaccine dosing instructions. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Access anti-HAV and Access anti-HAV IgM on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assaysSamples will be tested by comparing Access anti-HAV assay results to final anti-HAV sample status, and Access anti-HAV IgM results to final anti-HAV IgM status, according to respective instructions for use (IFU) or study guide, as applicable, to determine to determine non-reactive (NR), reactive (R), Negative, Positive or Equivocal (EQ). For evaluation of the clinical performance of Access anti-HAV assay, all clinical samples will be tested with the reference assays DiaSorin - LIAISON® Anti-HAV and SIEMENS Healthineers Atellica® IM Hepatitis A Total (aHAVT). For evaluation of the clinical performance of Access anti-HAV IgM assay, all clinical samples, except pre- and post-vaccinated patient samples, will be tested with the reference assays Abbott - ARCHITECT® HAVAb-IgM, DiaSorin - LIAISON® Anti-HAV IgM, and SIEMENS Healthineers Atellica IM® Hepatitis A IgM (aHAVM). | Diagnostic test | At-risk and/or signs and symptoms patients of HAV infection and/or HAV test ordered patients, Known anti-HAV IgM positive patients |
| Access anti-HAV on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assaysAll samples will be tested pre- and post-vaccination by comparing Access anti-HAV assay results to final anti-HAV status, according to respective instructions for use (IFU) or study guide, as applicable, to determine non-reactive (NR), initial reactivity, and repeat reactivity. For evaluation of the clinical performance of Access anti-HAV assay, all clinical samples will be tested with the reference assays DiaSorin - LIAISON® Anti-HAV and SIEMENS Healthineers Atellica® IM Hepatitis A Total (aHAVT). | Diagnostic test | HAV Pre- and post-vaccinated patients |
Primary outcome
Access Anti-HAV diagnostic accuracy measured as sensitivity and specificity
Time frame: Baseline
The endpoints will be diagnostic accuracy measured as clinical sensitivity and specificity of Access anti-HAV assay compared to final anti-HAV status
Access Anti-HAV IgM diagnostic accuracy measured as sensitivity and specificity
Time frame: Baseline
The endpoints will be diagnostic accuracy measured as clinical sensitivity and specificity of Access anti-HAV IgM assay compared to final anti-HAV IgM status.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HAV, run by Beckman Coulter, Inc. at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Access Anti-HAV diagnostic accuracy measured as sensitivity and specificity (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.