EUCTR2005-003761-16-GB
Active, not recruiting
Phase 1
Evaluation of pneumococcal conjugate vaccine (Prevenar) in patients with myeloma and chronic lymphocytic leukaemia - Pneumococcal conjugate vaccination in Haematology patients: Version 1
Department of R & D, Central Manchester and Manchester Children's Hospital NHS Trust0 sites97 target enrollmentOctober 14, 2005
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- 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.
- Sponsor
- Department of R & D, Central Manchester and Manchester Children's Hospital NHS Trust
- Enrollment
- 97
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
- •Previous splenectomy
- •Other secondary immunodeficiency state e.g. HIV infection
Outcomes
Primary Outcomes
Not specified
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