Low Grade Lymphoma

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01698866

Acronym

EVACC-B

Enrollment

Registered

2012-10-03

Start date

2012-07-31

Completion date

2018-02-28

Last updated

2016-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Indolent Lymphoproliferative Disorders

Keywords

Low grade lymphoma, follicular lymphoma, indolent lymphoproliferative disorders, Vaccin GenHevac B Pasteur

Brief summary

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.

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.

Interventions

BIOLOGICALVaccin GenHevac B Pasteur

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

France

Contacts

Primary ContactPierre FEUGIER, MD, PhD

p.feugier@chu-nancy.fr+33 3 83 15 32 82

Backup ContactJessica MICHEL, MD

je.michel@chu-nancy.fr+33 3 83 15 53 49

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026