To determine the effect of early (re) vaccination after acute lymphoblastic leukemia treatment. MedDRA version: 9.1 Level: LLT Classification code 10000850 Term: Acute lymphoid leukemia in remission
Conditions
Interventions
Trade Name: Prevenar
Pharmaceutical Form: Solution for injection
Trade Name: Pneumo 23
Pharmaceutical Form: Solution for injection
Trade Name: NeisVac-C
Pharmaceutical Form: Solution for injection
Sponsors
University Medical Center Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who finished DCOG ALL-10 protocol treatment, MR group. Age between 3 - 21 years old (inclusion criteria for ALL10 protocol is 1 year till 19 years old, treatment takes 2 years). Are the trial subjects under 18? yes 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) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: History of allergic response to vaccination Patients with Down syndrome Patients with acute lymphocytic leukaemia classified as standard and high risk according to the Dutch DCOG ALL-10 protocol. Patients with a stem cell transplantation in history Objection to vaccination because of religious reasons Patients with an primary or other acquired immunodeficiency in history
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of early (re) vaccinations after chemotherapy conform the current intensive chemotherapy for ALL;Secondary Objective: How is the immunophenotypic reconstitution as measured in blood correlated to immunoglobulin levels and specific antibody titers before and after vaccination ;Primary end point(s): -Need for revaccinations Serostatus DKTP-Hib, BMR, MenC, Pneu will be determined at T=0. -Effect of revaccinations and effect of polysaccharide pneumococcal vaccine Patients will be revaccinated with the DaKTP-Hib, BMR and MenC vaccines from the DVP. To test responses to T-cell independent polysaccharide antigens, the 23-valent polysaccharide pneumococcal vaccine will be used, after 2 initial vaccinations with the 7-valent conjugate pneumococcal vaccine. This initial conjugate vaccine was shown to induce better immune reponses in immunodeficient patients and primes for the 23-valent polysaccharide vaccine, according to current guidelines for immunization (for instance after splenectomy) to protect against invasive pneumococcal disease. (21) The additional serotypes in the 23-valent vaccine allow furthermore to measure polysaccharide responses towards a selection of the 16 antigens not included in the 7-valent vaccine. | — |
Countries
Netherlands
Outcome results
None listed