Low Grade Lymphoma (EVACC-B)

June 15, 2016 updated by: Central Hospital, Nancy, France

Evaluation of the Immune Response After Vaccination Against Hepatitis B in Patients With Indolent Lymphoproliferative Disorders With no Treatment.

The purpose of this study is to assess the seroconversion rate and the cellular immune response after vaccination against hepatitis B virus in patients with lymphoproliferative syndrome like chronic lymphocytic leukemia stade A and follicular lymphoma without of treatment criteria.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Rituximab is a human-mouse chimeric monoclonal antibody that targets the B-cell CD20. It is an indispensible drug for the treatment of B-cell lymphoproliferative syndrome which induced immunosuppression. So, the infectious complications increase. Reactivation of hepatitis B virus is one such complication that can lead in asymptomatic hepatitis to death. Prevention of hepatitis B reactivation is recommended like using nucleoside analog for patients with chronic hepatitis B or occult hepatitis and vaccination against virus for seronegative patients. The published data about efficacy of hepatitis b vaccination in onco-haematology are rare. therefore, we carried out a prospective study to assess efficacy of hepatitis B vaccination in patients with lymphoproliferative disorder.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandoeuvre Les Nancy, France, 54511
        • Recruiting
        • Pôle Hématologie CHU Nancy Brabois
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pierre FEUGIER, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years.
  • Lymphoproliferative indolent type of stage A CLL or follicular lymphoma with low tumor burden
  • No indication of chemotherapy during the seven months of the vaccination protocol.

HBV serology negative for HBsAg / Ab HBs / HBc Ab.

  • No history of vaccination against hepatitis B.

Exclusion Criteria:

  • Indication of immediate chemotherapy.
  • At least one HBV positive serologic marker .
  • History of vaccination against HBV.
  • Known neurodegenerative disease.
  • Pregnancy.
  • Febrile infection untreated.
  • Known allergy to any vaccine component.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vaccin GenHevac B Pasteur
vaccin GenHevac B Pasteur (Suspension for injection in pre-filled syringe / 20 μg microgram(s)Per day). In total, 3 injections at M0, M1 and M6
Biological: Vaccin GenHevac B Pasteur

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Describe the seroconversion rates at month 7 (M7) defined for a threshold of HBs Ab> 10 IU / L.
Time Frame: Month 7
Month 7

Secondary Outcome Measures

Outcome Measure
Time Frame
- Describe the seroconversion rate in month 2 (M2) defined for a threshold of HBs Ab> 10 IU / L.
Time Frame: Month 2
Month 2
Describe the cellular immune response post vaccination at M2 and M7.
Time Frame: Month 2 and Month 7
Month 2 and Month 7
To study the influence of age on the rate of seroconversion.
Time Frame: Month 0, Month 2 and Month 7
Month 0, Month 2 and Month 7
Describe vaccine-tolerance at M2 and M7.
Time Frame: Month 2 and Month 7
Month 2 and Month 7
To study the influence of sex on the rate of seroconversion.
Time Frame: Month 0, Month 2 and Month 7
Month 0, Month 2 and Month 7
To study the influence of lymphocyte count on the rate of seroconversion.
Time Frame: Month 0, Month 2 and Month 7
Month 0, Month 2 and Month 7
To study the influence of total immunoglobulin on the rate of seroconversion.
Time Frame: Month 0, Month 2 and Month 7
Month 0, Month 2 and Month 7
To study the influence of immunoglobulin M on the rate of seroconversion.
Time Frame: Month 0, Month 2 and Month 7
Month 0, Month 2 and Month 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Pierre FEUGIER, MD, PhD, Pôle Hématologie CHU Nancy Brabois, CHU de Nancy, Vandoeuvre les Nancy, FRANCE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

August 16, 2012

First Submitted That Met QC Criteria

October 1, 2012

First Posted (Estimate)

October 3, 2012

Study Record Updates

Last Update Posted (Estimate)

June 16, 2016

Last Update Submitted That Met QC Criteria

June 15, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-004968-30

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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