Evaluation of Prime-boost Anti-pneumococcal Vaccination in Patients With Diffuse Large B Cell Lymphoma Treated With Rituximab

  • STATUS
    Recruiting
  • End date
    Jul 3, 2022
  • participants needed
    36
  • sponsor
    University Hospital, Tours
Updated on 27 May 2021
lymphoma
pneumovax
vaccination
immunosuppression
diffuse large b-cell lymphoma
r-chop
anti-cd20 monoclonal antibody
prevnar
polysaccharide
conjugate vaccine

Summary

Pneumococcal infections remain frequent and potentially fatal. To prevent them, two anti-pneumococcal vaccines exist: a 13-valent conjugate vaccine (Prevenar) and a 23-valent polysaccharide vaccine (Pneumovax). For their utilization, several studies approved a prime-boost strategy. It consist two administer Pneumovax at least two months later than Prevenar. Patients with diffuse large B-cell Lymphoma (DLBCL) have a higher-risk to develop a pneumococcal infection. The main reason is immunosuppression, induced by rituximab (B cell depletion), chemotherapy and lymphoma. Patients are treated by immunochemotherapy, combining rituximab (anti-CD20 monoclonal antibody) and conventional chemotherapy (CHOP). However, those patients have a low rate of vaccination (about 15%).

Description

Pneumococcal infections remain frequent and potentially fatal. To prevent them, two anti-pneumococcal vaccines exist: a 13-valent conjugate vaccine (Prevenar) and a 23-valent polysaccharide vaccine (Pneumovax). For their utilization, several studies approved a prime-boost strategy. It consist two administer Pneumovax at least two months later than Prevenar. Patients with diffuse large B-cell Lymphoma (DLBCL) have a higher-risk to develop a pneumococcal infection. The main reason is immunosuppression, induced by rituximab (B cell depletion), chemotherapy and lymphoma. Patients are treated by immunochemotherapy, combining rituximab (anti-CD20 monoclonal antibody) and conventional chemotherapy (CHOP). However, those patients have a low rate of vaccination (about 15%). Also, in the current literature, rare studies investigated prime-boost immunogenicity in this relevant population. The investigators will evaluate vaccinal response of 10 serotype-specific immunoglobulin G (1, 3, 4, 6B, 7F, 9V, 14, 18C, 19F, 23F) at different time of treatment.

The investigators search to compare efficiency of prime-boost anti-pneumococcal vaccination according to the time of prevenar administration (before or after immunochemotherapy) and to the dose of Prevenar (single or double-dose).

Details
Condition Pneumococcal infection, Diffuse Large B-Cell Lymphoma, Pneumococcal Disease, streptococcus pneumoniae infections, pneumococcal infections
Treatment Anti-pneumococcal vaccination with prime-boost strategy in patients with diffuse large B cell lymphoma
Clinical Study IdentifierNCT04214444
SponsorUniversity Hospital, Tours
Last Modified on27 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

De novo Diffuse Large B-Cell Lymphoma diagnostic (according 2016 World Health Organization (WHO) classification)
Treatment decision by immunochemotherapy (R-CHOP)
Age over 18 years old
Negative pregnancy test at inclusion
Active contraception at inclusion
Free and informed consent procedure at inclusion
Affiliation of the social security system

Exclusion Criteria

Patient with prior treatment by immunotherapy or chemotherapy
Patient with prior treatment by debulking chemotherapy (COP)
Patient with prior treatment by high-dose of corticosteroids
Patients with an autoimmune disease
Patients with a diffuse large B-cell lymphoma from transformation (follicular lymphoma, chronic lymphoid leukemia)
Immunosuppressed patient with : asplenia, hereditary immunodeficiency disorder, infection by HIV, hepatitis B or C viruses, transplanted patient, hematopoietic stem cell transplantation, nephrotic syndrome, meningeal breach, cochlear implants
Patients vaccinated in the last month before inclusion
Patients with prior transfusion of blood-products or immunoglobulins in the last three months before inclusion
Patient with bleeding disorders or thrombopenia contraindicating intramuscular injection
Patient with prior pneumococcal documented infection
Patient with current pregnancy and/or breastfeeding
Patient under curatorship or guardianship
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note