Hepatitis CTETRANCT01534728
Identification of Hepatitis C Virus (HCV) Specific T Cells
An observational study of Hepatitis C, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Nearly 175 million people worldwide are infected by Hepatitis C Virus (HCV), close to 3% of the global population. Contrary to other chronic infections such as HIV, clearance of HCV is possible. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hepatitis C
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Mar 2014
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Chronic HCV Patients
Who may be able to join
- Male or female subjects
- Age between 18 and 60 years
- Signed Consent Form
- Patient affiliated to social security
- Infection with HCV genotype 1 or 4 : infection defined by the presence of HCV antibodies and HCV RNA in plasma allowing a measure of the circulating viral load, or resolved infection as defined by the presence of antibodies HCV, normal transaminases and negative HCV RNA measured by PCR (two consecutive tests)
- Normal ECG in the judgment of the investigator
- Venous access allowing a leukapheresis
- Review hematologic allowing the realization of a leukapheresis to investigator assessment.
Who cannot join
- Patients being treated for HCV
- HBV infection defined by the presence of HBsAg (serology already known, test not done specifically for research)
- HIV infection defined by the detection of HIV antibodies (serology already known, test not done specifically for research)
- Patients with cirrhosis
- Patients addicted to narcotics use
- Patients with excessive alcohol consumption (more than 3 units per day)
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- Pregnancy
- Contraindications to leukapheresis
- History of vasculitis related or unrelated to HCV
- A person deprived of liberty by judicial or administrative decision.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of HCV Specific T Cells Using Tetramer Technology - TETRA Study
Nearly 175 million people worldwide are infected by Hepatitis C Virus (HCV), close to 3% of the global population. Contrary to other chronic infections such as HIV, clearance of HCV is possible. While much is now known about the response to treatment in chronic HCV patients, the fact that acute HCV infection is typically asymptomatic (~80% of patients show no clinical signs) has made it challenging to define the mechanisms involved in spontaneous clearance.
Immune protection against HCV is thought to be largely dependent upon the CD8 T cell response. Therefore using the latest T cell detection technology the investigators will develop a panel of tetramers specific for all potential HCV epitopes. To produce the tetramers the investigators will utilize HLA ligand exchange technology which allows the production of very large collections of peptide-HLA multimers for T cell staining. The investigators have already performed a large scale identification of HCVg1 and HCVg4 CD8 T cell epitopes using published viral sequences and algorithm prediction databases. Using this information the investigators are currently in the process of developing collections of peptide-HLA multimers for T cell staining. Therefore the investigators require large lymphocyte pools from HCV+ patients to test both the sensitivity and accuracy of each tetramer on the CD3+CD8+ T cells.
Read more
The investigators wish to examine cells from patients infected with HCV g1 and HCV g4 to be able to test and compare the frequency of possible conserved epitopes present in both HCVg1 and HCVg4 infections. Once developed this technique will allow us to examine all virus-specific CD8 T cells present in patients with acute or chronic disease, and on smaller quantities of blood. The development of these technologies will also allow us to tailor such future diagnostic tests to local populations where a viral subspecies is prevalent; for example using North-African HLA alleles for HCVg4 epitopes.
The work carried out using such assays will provide important immunological correlates of viral clearance that will impact vaccine design for HCV infections. Finally, the identification of protective CD8 T cells specific for HCV may allow new diagnostic tools with predictive powers of disease progression that can be used on any flow cytometer machine.
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, CD8 epitopes
- Medical subject headings
- Hepatitis C
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the percentage of CD8 T lymphocytes that have bound to the tetramers (CD3+CD8+ HCV-tetramer+) in infected patients
After Leukapheresis, T lymphocytes will be isolated using a Ficoll density gradient and directly labeled with tetramers (CD3+CD8+ HCV-tetramer+) in infected patients. Binding to the tetramers will be assessed by flow cytometry.
Measured: No later than 1 month after the inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Matthew L. ALBERT, MD, PhD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534728
- Sponsor's protocol ID
- C11-33
- Other IDs
- 2011-A01226-35
- Acronym
- TETRA
- Status last verified
- Mar 2014
- First submitted
- 14 Feb 2012
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Molinos-Albert LM, Baquero E, Planchais C, Doceul V, El Costa H, Mottez E, Mallet V, Pol S, Albert ML, Pavio N, Alanio C, Dimitrov JD, Mouquet H. Structural basis for hepatitis E virus neutralization by potent human antibodies. Sci Adv. 2025 May 9;11(19):eadu8811. doi: 10.1126/sciadv.adu8811. Epub 2025 May 7.
PubMed 40333967Alanio C, Nicoli F, Sultanik P, Flecken T, Perot B, Duffy D, Bianchi E, Lim A, Clave E, van Buuren MM, Schnuriger A, Johnsson K, Boussier J, Garbarg-Chenon A, Bousquet L, Mottez E, Schumacher TN, Toubert A, Appay V, Heshmati F, Thimme R, Pol S, Mallet V, Albert ML. Bystander hyperactivation of preimmune CD8+ T cells in chronic HCV patients. Elife. 2015 Nov 14;4:e07916. doi: 10.7554/eLife.07916.
PubMed 26568315
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of HCV Specific T Cells Using Tetramer Technology - TETRA Study
- ClinicalTrials.gov ID
- NCT01534728
- Acronym / sponsor ID
- TETRA / C11-33
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, CD8 epitopes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Feb 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 17 Feb 2012 (estimated)
- 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.
Nearly 175 million people worldwide are infected by Hepatitis C Virus (HCV), close to 3% of the global population. Contrary to other chronic infections such as HIV, clearance of HCV is possible. While much is now known about the response to treatment in chronic HCV patients, the fact that acute HCV infection is typically asymptomatic (~80% of patients show no clinical signs) has made it challenging to define the mechanisms involved in spontaneous clearance.
Immune protection against HCV is thought to be largely dependent upon the CD8 T cell response. Therefore using the latest T cell detection technology the investigators will develop a panel of tetramers specific for all potential HCV epitopes. To produce the tetramers the investigators will utilize HLA ligand exchange technology which allows the production of very large collections of peptide-HLA multimers for T cell staining. The investigators have already performed a large scale identification of HCVg1 and HCVg4 CD8 T cell epitopes using published viral sequences and algorithm prediction databases. Using this information the investigators are currently in the process of developing collections of peptide-HLA multimers for T cell staining. Therefore the investigators require large lymphocyte pools from HCV+ patients to test both the sensitivity and accuracy of each tetramer on the CD3+CD8+ T cells.
The investigators wish to examine cells from patients infected with HCV g1 and HCV g4 to be able to test and compare the frequency of possible conserved epitopes present in both HCVg1 and HCVg4 infections. Once developed this technique will allow us to examine all virus-specific CD8 T cells present in patients with acute or chronic disease, and on smaller quantities of blood. The development of these technologies will also allow us to tailor such future diagnostic tests to local populations where a viral subspecies is prevalent; for example using North-African HLA alleles for HCVg4 epitopes.
The work carried out using such assays will provide important immunological correlates of viral clearance that will impact vaccine design for HCV infections. Finally, the identification of protective CD8 T cells specific for HCV may allow new diagnostic tools with predictive powers of disease progression that can be used on any flow cytometer machine.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Chronic HCV Patients
Key inclusion criteria (8 listed)
- Male or female subjects
- Age between 18 and 60 years
- Signed Consent Form
- Patient affiliated to social security
- Infection with HCV genotype 1 or 4 : infection defined by the presence of HCV antibodies and HCV RNA in plasma allowing a measure of the circulating viral load, or resolved infection as defined by the presence of antibodies HCV, normal transaminases and negative HCV RNA measured by PCR (two consecutive tests)
Key exclusion criteria (10 listed)
- Patients being treated for HCV
- HBV infection defined by the presence of HBsAg (serology already known, test not done specifically for research)
- HIV infection defined by the detection of HIV antibodies (serology already known, test not done specifically for research)
- Patients with cirrhosis
- Patients addicted to narcotics use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of the percentage of CD8 T lymphocytes that have bound to the tetramers (CD3+CD8+ HCV-tetramer+) in infected patients
Time frame: No later than 1 month after the inclusion visit
After Leukapheresis, T lymphocytes will be isolated using a Ficoll density gradient and directly labeled with tetramers (CD3+CD8+ HCV-tetramer+) in infected patients. Binding to the tetramers will be assessed by flow cytometry.
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 21 Aug 2026.
- Results publication: PubMed 40333967Molinos-Albert LM, Baquero E, Planchais C, Doceul V, El Costa H, Mottez E, Mallet V, Pol S, Albert ML, Pavio N, Alanio C, Dimitrov JD, Mouquet H. Structural basis for hepatitis E virus neutralization by potent human antibodies. Sci Adv. 2025 May 9;11(19):eadu8811. doi: 10.1126/sciadv.adu8811. Epub 2025 May 7.
- Results publication: PubMed 26568315Alanio C, Nicoli F, Sultanik P, Flecken T, Perot B, Duffy D, Bianchi E, Lim A, Clave E, van Buuren MM, Schnuriger A, Johnsson K, Boussier J, Garbarg-Chenon A, Bousquet L, Mottez E, Schumacher TN, Toubert A, Appay V, Heshmati F, Thimme R, Pol S, Mallet V, Albert ML. Bystander hyperactivation of preimmune CD8+ T cells in chronic HCV patients. Elife. 2015 Nov 14;4:e07916. doi: 10.7554/eLife.07916.
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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.
Matthew L. ALBERT, MD, PhD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site 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 8 inclusion and 10 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 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Assessment of the percentage of CD8 T lymphocytes that have bound to the tetramers (CD3+CD8+ HCV-tetramer+) in infected patients (time frame: No later than 1 month after the inclusion visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01534728, which also lists 2 linked publications.
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 21 Aug 2026.