Healthy Subjects
Conditions
Interventions
Product Name: Junctional Peptides from the BCR-ABL junction
Product Code: BCR-ABL vaccine
Pharmaceutical Form: Solution for injection
Current Sponsor co
Sponsors
University of Liverpool and Royal Liverpool University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Aged 18 or over and previously a volunteer apheresis blood donorAble to give informed written consent.HLA-A3 and/or –B8 positiveNot currently donating to the National Blood ServiceNo serious concomitant illness (eg heart disease) that might preclude completion of the study.Serum creatinine, alanine transaminase and blood count within normal limits.Negative pregnancy test in women of childbearing age. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnancy or lactatingReceiving steroids or other immunosuppressive agentsCurrently donating to National Blood Service
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: EvaluateToxicity of BCR-ABL Peptide in normal subjects;Secondary Objective: Assessment of immune response to BCR-ABL in healthy subjects undergoing vaccination with peptides from the BCR-ABL fusion junction.;Primary end point(s): The primary study endpoint is the immunological response to vaccination. This will be assessed by measuring cytotoxic T-lymphocyte (CTL) and CD4+ responses to BCR-ABL. A secondary endpoint is whether these otherwise healthy subjects express BCR-ABL. This oncoprotein is the molecular hallmark of CML, but has also been detected in up to 30% of normal subjects using nested PCR. Subsequent unpublished data suggest that the true frequency of BCR-ABL positivity is much lower than this. Its clinical significance in otherwise healthy subjects is not known. At present it appears likely that its detection is of no clinical significance, but no long-term follow up data are available on such subjects. All entrants to the study will be assessed molecularly (using nested polymerase chain reaction (PCR)). The strategy for subjects in whom BCR-ABL transcripts are detected is given in section 2.6. | — |
Countries
United Kingdom
Outcome results
None listed