Evaluation of pneumococcal conjugate vaccine (Prevenar) in patients with myeloma and chronic lymphocytic leukaemia - Pneumococcal conjugate vaccination in Haematology patients: Version 1
- Conditions
- 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.
- Registration Number
- EUCTR2005-003761-16-GB
- Lead Sponsor
- Department of R & D, Central Manchester and Manchester Children's Hospital NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 97
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method