Clinical Data

Pneumococcal Infections in Solid and Haematological Malignancies, and Bone Marrow Transplant Recipients: Clinical and Immunogenicity Data of Pneumococcal Vaccines

A systematic review of 26 studies on the safety and efficacy of pneumococcal vaccines in oncohaematological patients revealed that PCV13 vaccination is well tolerated in patients with CLL, and provokes an effective immune response in considerable proportion of these patients. For attaining an optimal immune response, use of PCV13 is recommended as early as possible following CLL diagnosis.¹ A study evaluated the effect of a system base intervention of providing PCV13 before initiating chemotherapy and/or biological treatment. As a result of the intervention, a 35% decrease in the number of hospitalised patients with pneumonia or sepsis was observed. In addition, a significant trend towards a decrease in mortality pre-versus post-intervention was observed (11% vs. 7%).²

A randomised study by the Swedish CLL group assessed whether patients with untreated CLL benefit from PCV13 in terms of immune response, as compared with PPSV23. The results indicated that after 1 month of vaccination, PCV13 yielded superior immune response in 10/12 serotypes, as compared with PPSV23, and in 5/12 serotypes after 6 months of vaccination. Since the immune response of PCV13 was superior to that of PPSV23 in patients with previously untreated CLL, the study proposed that PCV13 should be included in the immunisation programmes for patients with CLL, and should be administered as early as possible following the diagnosis of the disease.³ Previously, a study investigated the antibody persistence in patients with CLL after pneumococcal conjugate vaccination. Five years after vaccination with PCV7, the percentage of patients with CLL with antibody levels that provide protection against IPD ranged between 29% and 71%. These results indicated that PCVs result in antibody persistence, at least for 5 years in patients with CLL.⁴   

A prospective cohort study evaluated response to PCV13 in patients with multiple myeloma as compared with healthy controls. The study enrolled 7 patients with multiple myeloma and 18 control subjects. Apart from assessing the initial response to PCV13, the study also compared the durability of response at 6 months following vaccination. The findings revealed that PCV13 elicits similar initial immune response in both patients with multiple myeloma and control subjects. However, the duration of the response might diminish in patients with multiple myeloma when compared with healthy subjects.⁵

Pneumococcal Infections in Solid and Haematological Malignancies, and Bone Marrow Transplant Recipients: Clinical and Immunogenicity Data of Pneumococcal Vaccines   

A retrospective study performed in Paris over a period of 3 years, from January 2004 to December 2006, evaluated the serotype distribution of S. pneumoniae in 25 consecutive pneumococcal infections in oncohaematology and HSCT patients. The serotype coverage by PCV13, PPSV23 and PCV7 were found to be 84%, 92% and 76%, respectively.⁶ In a small open randomised study, as compared with PPSV23, PCV13 led to a better response in patients with B-cell lymphoma, 12 months after rituximab treatment.³ A study on 24 previously untreated patients with CLL revealed that PCV13 is well tolerated and effective (58.3% immune response) in these patients, and for achieving optimal vaccination response, PCV13 is recommended to be administered as soon as possible following diagnosis.⁷   

Clonal proliferation of differentiated plasma cells leads to MGUS, which is measured by serum concentration of the M-protein. Since MGUS patients have increased risk of developing infections, pneumococcal vaccines are recommended for patients with such lymphoproliferative disorders. Pasiarski et al. evaluated the immune response to PCV13 in treatment-naïve MGUS patients as compared with healthy subjects. The study reported that PCV13 is well tolerated and effective in MGUS patients, and in case of unvaccinated MGUS patients, immunisation with PCV13 should be done as early as possible following diagnosis. In MGUS patients, concentration of serum M-proteins could be a useful predictor of PCV13 effectiveness since the study revealed that PCV13 vaccination is more effective in patients with lower M-protein concentration.⁸   

A prospective randomised controlled trial evaluated whether administering PCV13 on the first day of chemotherapy is non-inferior to its use 2 weeks before chemotherapy initiation, in adult patients with solid malignancies. No significant difference was observed when patients were vaccinated on the first day of chemotherapy, or 2 weeks prior to chemotherapy initiation. During adjuvant chemotherapy, adequate overall antibody response to PCV13 was observed in both patients with gastric and colorectal cancer.⁹   

Patients with SCD, a common inherited haematological disorder, are also at increased risk of IPD, and are dependent on pneumococcal vaccination for the prevention of infection. A study evaluated the immunogenicity of PCV7 (prior to PCV13 introduction) followed by PPSV23 administered at 2 and 5 years of age and then every 5 years thereafter, in patients with SCD. The results revealed that a sufficient immune response to PPSV23 was not maintained up to 5 years in a significant proportion of patients with SCD. At an average of 37 months following vaccination, only 36% of patients had protective levels of anti-pneumococcal antibody titres. The study concluded that this vaccination strategy may not lead to optimum maintenance of anti-pneumococcal immunity in patients with SCD.¹⁰