HIV positive adults with out previous PPV23 or PCV7 vaccination MedDRA version: 14.1 Level: LLT Classification code 10035652 Term: Pneumococcus infection in conditions classified elsewhere and of unspecified site System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: PREVENAR 13*IM 10SIR 0,5ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Vaccino pneumococcico coniugato 13 valente
CAS Number: NA
Current Sponsor code: NA
Other descrip
Sponsors
AZIENDA OSPEDALIERA SENESE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: age > 18 years availability from the part of the patient or the legal guardian to furnish his/her own consent free and informed access to the structures in out-patient regime or of Day Hospital CD4. 200 cells / µl in two determinations consecutive precedents to the T0 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: age > 65 years acute infectious pathology in fit antibiosi in action or pregressa < = 7 days previous vaccination with PPV23 or with PCV7 pregnancy therapy immunomodulant in fit immunodepression not HIV related
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the rate of nasal colonization by different pneumococcal serotypes in HIV-positive adults, in relation to baseline antibody titers at T0; to define serological response after 2 doses of PCV13 vaccine (booster dose after 8 weeks) in HIV+ adults; to evaluate the effect of 2 doses PCV13 vaccine in terms of nasal pneumococcal carriage and occurrence of invasive pneumococcal diseases.;Secondary Objective: To determine pneumococcal serotypes and chemosusceptibility to different antibiotic and to evaluate the prevalence of multiresistant strains; to evaluate molecular epidemiology of pneumococcal isolates.;Primary end point(s): to define serological response after 2 doses of PCV13 vaccine (booster dose after 8 weeks) in HIV+ adults;Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To determine the rate of nasal colonization by different pneumococcal serotypes in HIV-positive adults, in relation to baseline antibody titers at T0; to evaluate the effect of 2 doses PCV13 vaccine in terms of nasal pneumococcal carriage and occurrence of invasive pneumococcal diseases; to determine chemosusceptibility to different antibiotic and to evaluate the prevalence of multiresistant strains to evaluate molecular epidemiology of pneumococcal isolates.;Timepoint(s) of evaluation of this end point: 2 years | — |
Countries
Italy
Contacts
Public ContactUOC Malattie Infettive Univ.
Azienda Ospedaliera Senese - Universita' degli Studi di Siena
Outcome results
None listed