Pneumococcal Vaccination in Patients With Chronic Lymphocytic Leukaemia

NCT05145101 | Unknown FDA Drug

• 1 other identifier: W20_197#20.228
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the antibody response after vaccination with the 13-valent pneumococcal conjugated vaccine (PCV13) followed 2 months later by the 23-valent polysaccharide vaccine (PPSV23) in adults with chronic lymphocytic leukemia will be investigated.

Conditions

Pneumococcal Infections; Chronic Lymphocytic Leukemia; Vaccine-Preventable Diseases; Invasive Pneumococcal Disease, Recurrent Isolated

Outcome Measures

Primary Outcomes (1)

• serologic response rate

  Proportion of participants with a ≥4-fold increase in serotype specific anti-pneumococcal IgG for ≥6/9 serotypes

  1-2 months after vaccination schedule

Secondary Outcomes (2)

• Serologic protection rate

  1-2 months after vaccination

• Geometric mean concentrations of serotype specific anti-pneumococcal IgG for 9 pneumococcal serotypes

  Month 0, month 4

Interventions

Prevnar13 BIOLOGICAL

Patients receive one dose of Prevenar13 followed by one dose of Pneumovax23 2 months later

Also known as: Pneumovax23

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

As part of routine care, all adult CLL patients naïve to pneumococcal vaccination must receive one dose of Prevenar13® followed by one dose of Pneumovax23® 2 months later. According to the current local standard of care for immunosuppressed individuals, the response to vaccination will be assessed by measuring pneumococcal antibody levels before and 4-8 weeks after vaccination

You may qualify if:

• CLL
• Age \>17
• Naive to pneumococcal vaccination

You may not qualify if:

• Not able/willing to participate

Sponsors & Collaborators

• Hannah Garcia Garrido: lead

Study Sites (1)

Amsterdam UMC Locatie AMC

Amsterdam-Zuidoost, 1105 AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Pneumococcal Infections; Leukemia, Lymphocytic, Chronic, B-Cell; Vaccine-Preventable Diseases; IRAK4 Deficiency

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hannah Garcia Garrido, MD

CONTACT

+31205663800; h.m.garciagarrido@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 6, 2021
• Study Start: May 7, 2020
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: December 20, 2021

Record last verified: 2021-12

Locations

NL (1)