Serological response to antipneumococcal vaccination and consequent impact on Streptococcus pneumoniae nasal carriage in HIV positive adults

Conditions: HIV positive adults with out previous PPV23 or PCV7 vaccination
MedDRA version: 14.1Level: LLTClassification code 10035652Term: Pneumococcus infection in conditions classified elsewhere and of unspecified siteSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2011-004518-40-IT

Lead Sponsor: AZIENDA OSPEDALIERA SENESE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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