Pneumococcal disease is a common form of meningitis, septicaemia and pneumonia. Those individuals at highest risk include children, the elderly and persons whose immune systems are impaired. This latter group is diverse includes patients with the haematological disorders myeloma and chronic lymphocytic leukaemia in whom infections are a leading cause of death.
Conditions
Interventions
Trade Name: PREVENAR
Product Name: PREVENAR
Product Code: N/A
Pharmaceutical Form: Suspension for injection
Other descriptive name: Pneu
Sponsors
Department of R & D, Central Manchester and Manchester Children's Hospital NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with multiple myeloma as defined by: Demonstration of: - Over 10% plasma cells in the bone marrow And at least one of the following: - Lytic lesions on radiographic X-ray imaging - A paraprotein in serum or urine Patients with CLL as defined by: Demonstration of: - A clonal population of B-lymphocytes with characteristic immunophenotype (CD5+, CD23+, Weak SIg, FMC7-ve) in peripheral blood, bone marrow or lymph node biopsy. Aged = 18 years Able to give written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Immunoglobulin therapy in the previous 4 months General contraindications to immunisation as defined in the UK handbook “Immunisation against Infectious Disease” Currently receiving treatment prior to planned peripheral blood stem cell/bone marrow transplant Less than 6 months post peripheral blood stem cell/bone marrow transplant Receiving treatment with high dose steroids (monthly pulsed dexamethasone or > 1mg/kg of prednisolone as a continuous dose) Platelets < 30x109/L Prior vaccination with Prevenar Prior vaccination with 23-valent pneumococcal vaccine in previous 6 months Pregnancy Previous splenectomy Other secondary immunodeficiency state e.g. HIV infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether the pneumococcal conjugate vaccine (Prevenar) can provide immunity from invasive pneumococcal disease in a group of haematology patients at high risk of infective complications.; Secondary Objective: 1. To determine whether the immune response to the conjugate vaccine (Prevenar) differs between individual’s naïve to the 23-valent pneumococcal vaccine and those who have received at least one previous dose. 2. To assess whether the response to subsequent vaccination with the 23-valent polysaccharide vaccine is enhanced by prior vaccination with the conjugate vaccine (Prevenar). 3. To determine the optimum dosage and schedule of the conjugate vaccine. 4. To evaluate the immune response in relationship to disease related variables. These will include disease stage, treatment and laboratory markers of the immune system function as a whole. This will improve our understanding of the mechanisms resulting in vaccine success and failure. ; Primary end point(s): The immunogenicity of the pneumococcal conjugate vaccine (Prevenar) as determined by serotype-specific IgG levels. These will be reported as the geometric mean concentrations with 95% confidence intervals. Changes between the baseline antibody level and the level after 2 doses of Prevenar will be assessed using a paired two-tailed T-test. In addition the proportion of patients with serotype-specific IgG antibody levels >0.35µg/ml and >0.5µg/ml will be calculated and the data will be analysed to assess those achieving either a 2 or 4 fold increase from pre-immunisation levels. | — |
Countries
United Kingdom
Outcome results
None listed