Allergic asthma and type 1 diabetes mellitus in pediatric subjects.
Conditions
Interventions
Trade Name: Prevenar 13
Product Name: Prevenar 13
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Pneumococcal polysaccharide serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F,
Sponsors
Federico Martinon Torres
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria applicable to all groups (1, 2, 3): 1. Subjects 5-14 years of age (inclusive) at inclusion. 2. Subjects who have given written informed assent (if applicable) and whose parents / guardians have given written informed after they have explained the nature of the study consent. 3. Subjects who are available for all scheduled study visits. Inclusion criteria applicable to group 1: 4. Subjects diagnosed with respiratory allergic asthma according to criteria of the Global Initiative for Asthma (GINA 2014 review [41]). Allergic sensitization demonstrated by specific cutaneous blood test (Skin Prick Test (SPT)) and / or immunoglobulin E. Inclusion criteria applicable to group 2: 4. Subjects diagnosed with type 1 diabetes mellitus insulin-dependent. Inclusion criteria applicable to Group 3: 4. Healthy immunocompetent subjects with good health determined by medical history, physical examination and clinical judgment of the investigator. Healthy subject is defined as that which has no known immune-based disease. Are the trial subjects under 18? yes Number of subjects for this age range: 150 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: 1. Prior vaccination with Prevenar 13® 2. Previous anaphylactic reaction or allergy to any vaccine or vaccine component. 3. Contraindications to vaccination with any standard pediatric vaccine. 4. Subjects with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection 5. History of invasive S. pneumoniae demonstrated by culture. 6. Known or suspected immune deficiency or suppression. 7. Congenital malformation most known character or serious chronic illness. 8. Neurological disease or major process (history of seizures will be assessed at the discretion of the investigator), either stable or evolving, such as cerebral palsy, encephalopathy, hydrocephalus or other relevant disease from a clinical point of view. 9. Pregnant women who may become pregnant or are breastfeeding. 10. Women of childbearing age who have not used or plan to use acceptable contraceptive measures during the 4-month study. Are acceptable contraceptive oral hormonal contraceptives, injected or implanted, barrier methods (diaphragm or condom with spermicide), intrauterine device, or abstinence. If subjects are sexually active, they should have used one of the accepted methods of birth control for at least 60 days before inclusion in the study. 11. Patients receiving treatment with oral corticosteroids continuously or received oral corticosteroids within 30 days prior to inclusion. 12. Patients who are under treatment: specific desensitizing therapy allergens or anti-IgE monoclonal antibody. 13. Patients who have received any vaccinations in the 30 days prior to inclusion in the study or intend to receive in the clinical trial (except the flu vaccine). 14. Illness or process more character in the investigator's opinion, could substantially increase the risk associated with the subject's participation in the study and its completeness or prevent the evaluation of the subject's response. 15. Use of an investigational product (drug or vaccine) in research or not registered within 30 days prior to the first dose of study vaccine or plan to receive during the course of this study. 16. Subject who is a direct descendant of study personnel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main purpose of this clinical trial is to evaluate the possible inmunoregulatory capacity of vaccination with Prevenar 13 in a pediatric population with two pathologies with a well-defined inmunological basis: type 1 diabetes mellitus and allergic asthma.;Secondary Objective: ? In vivo and in vitro study of the effect of vaccination on the number and function of T cell populations (Th1, Th2, Treg and Th17) and B cell populations (B10 regulatory cells). ? In vivo and in vitro study of the altered response of chemokines / cytokines induced by vaccination and its interaction with T cells and B. ? Analysis of dose effect on changes in cell subpopulation under study. ? Comparison of the immunomodulatory response to vaccination among individuals with underlying disease and immune healthy control individuals. ? Evaluation of anti-inflammatory therapeutic claims made by vaccination. ? Analysis of differential transcriptomic response induced by vaccination in all three groups.;Primary end point(s): ? Number and function of regulatory T cell population (CD4 + CD25 + Foxp3 +) ? Number and function of regulatory B cell population (cell B10) ? Number and function of Th1 cell population ? Number and function of Th2 cell population ? Number and function of Th17 cell population ? Transcriptomic markers;Timepoint(s) of evaluation of this end point: After obtaining the samples, which will be held on day 1, day 56 and day 112 of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Levels of cytokines / chemokines secreted: IL2, IL4, IL5, IL6, IL10, IFN-gamma, TNF-alpha and IL17. ? Density of the pathogen in the nasopharynx. ? Levels of specific immunoglobulins. ? Marker of inflammation (ultra sensitive PCR).;Timepoint(s) of evaluation of this end point: After obtaining the samples, which will be held on day 1, day 56 and day 112 of the study. | — |
Countries
Spain
Contacts
Public ContactLucia Vilanova Trillo
Lucia Vilanova Trillo
Outcome results
None listed