NCT02909023

Performance of the HBV ELISPOT in the Detection of the T Cellular Immune Response in Patients Infected by HBV or Cured

Performance of the Hepatitis B Virus (HBV) ELISPOT in the Detection of the T Cellular Immune Response in Patients Infected by HBV or Cured

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 34 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Activation of the immune system against a pathogen can be considered one of the most effective interventions in the field of infectious diseases. Transgene is developing a therapeutic vaccine "TG1050" for the treatment of patients with chronic and treated Hepatitis B. This biotherapy compound is for the development of T cellular immune response in these patients in order to achieve the total elimination of infected cells. Therefore it is necessary to have measures of ways to assess accurately and reliably the presence of such a response in the study subjects.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	blood samples are performed to measure active T cellular immune response during a routine visit	During the visit 1 (V1), after signing the informed consent, 40 mL blood sampling are carried out and analyzed with the test ELISPOT to check if the patient shows a T immune response against HBV. The visit 2 will be performed 4-8 weeks (depending on the availability of the patient) following V1 visit, in case the patient shows an immune response against HBV positive T following the sample taken at V1. 150 ml blood sampling are carried out at this visit.

Timeline

• Start date: 2016-07-01
• Primary completion: 2016-09-01
• Completion: 2016-11-01
• First posted: 2016-09-21
• Last updated: 2016-12-29

Locations

1 site across 1 country: France