This study will be conducted as a longitudinal study. Former studies have shown that immunity is affected after treatment against childhood cancer. We want to investigate humoral and cell-mediated immunity specifically targeted for varicella and measles, during and after treatment for childhood cancer. We also want to investigate vaccin response for varicella and measles.
Conditions
Interventions
Pharmaceutical Form: Lyophilisate and solvent for solution for injection
INN or Proposed INN: J05BD52
Other descriptive name: MEASLES, MUMPS AND RUBELLA VACCINE (LIVE)
Concentration unit: ml millilitr
Sponsors
Västra Götalandsregionen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Children and young people (0-18.0 years) who start cancer treatment at the childhood cancer center in Gothenburg. • Known vaccination status for measles and chickenpox before start of cancer treatment. • Oral and written information for the study and signed consent form. Are the trial subjects under 18? yes Number of subjects for this age range: 160 F.1.2 Adults (18-64 years) no 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: • Known pre-existing primary immunodeficiency. • Patients planned for relapse therapy or will undergo allogeneic stem cell transplantation (SCT). • Known contraindication to any of the suggested vaccines.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: After cancer treatment, it is known that the level of antibodies formed after previous vaccination decreases. There is a difference in the residual concentration of antibodies between groups that have received low and high intensive chemotherapy treatment, respectively. Studies and experience also show that vaccinations after completing cancer treatment do not give high enough titers for protection against, for example, measles. Vaccine response will be investigated, thereby looking for immunological variables that may be able to predict a good immune response. The results may form a better scientific basis for recommendations on prophylaxis and vaccinations against chickenpox and measles for childhood cancer patients.;Secondary Objective: Measles and chickenpox are two of our most contagious infectious diseases. For cancer patients, it is of most importance to find out immunity to these two diseases in order to be able to treat the patient properly during ongoing treatment and after treatment has ended. In the event of an outbreak of measles or chickenpox, it can have life-threatening consequences in patients with impaired immunity, such as disseminated cutaneous infection, pneumonia and meningitis. Cell-mediated immunity (CMI) includes cell types such as macrophages, natural killer (NK) cells, B lymphocytes and T lymphocytes. When the cells are activated via antigen (foreign body substance from the outside, e.g. virus), a reaction with cytokine activation follows. Cell-mediated immunity (CMI) is profiled to take care of intracellular microorganisms such as viruses and bacteria. Studies on cell-mediated immunity to varicella and measles are scarce and need further evaluation. ;Primary end point(s): Primära frågeställningar Primary endpoints 1) Immunity after revaccination with varicella vaccine after treatment for childhood cancer, measured as IgG antibodies to VZV before and after vaccination. (Proportion (%) of patients with protective level of V | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Blood samples are taken at 8 specific timepoints: -Before start of cancer treatment. -An occasion during treatment. -A few weeks after the end of treatment. -Before vaccination against varicella. -2-3 months after vaccination against varicella. -Before vaccination against measles. -2-3 months after vaccination against measles. -1 year after the last vaccination. ;Secondary end point(s): Secondary endpoints 1) Proportion of patients who lose immunity to varicella and morbidity after cancer treatment (Proportion (%) immune patients before treatment - proportion (%) immune patients after treatment). 2) Change in CMI against varicella and measles during treatment and after revaccination. Comparisons will be made with a healthy control group. 3) Subgroup analyzes: Differences in antibody levels and CMI between different diagnostic groups (leukemia / solid tumor), different age groups, low- and high-intensity treatment and preimmune versus non-immune groups at specific times. | — |
Countries
Sweden
Contacts
Public ContactDrottning Silvias barnsjukhus
Barncancercentum i Västra Sverige
Outcome results
None listed