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Pneumococcal Infections clinical trials

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NCT ID: NCT05412030 Recruiting - Clinical trials for Pneumococcal Infections

A Phase 2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of AFX3772 Vaccine in Healthy Infants

Start date: June 16, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase 2 clinical study to support the use of AFX3772 in healthy infants for the prevention of pneumococcal disease. The purpose of this study is to determine the safety, tolerability, and immunogenicity of 3 different dose levels of AFX3772 compared with PCV13. Infants approximately 2 months of age will be enrolled and receive 4 doses of study vaccine over 8 protocol-defined visits spanning a duration of approximately 18 to 21 months. Part 1 is the dose escalation, lead-in portion of the study in which infants at each dose level will be randomized 3:1 in sequential cohorts of increasing doses of AFX3772 or PCV13. Enrollment in Cohorts 2 and 3 will proceed following Data Monitoring Committee (DMC) review of cumulative safety and tolerability data from preceding cohorts. Following completion of DMC review of safety and tolerability data for the cohorts enrolled in Part 1, additional infants will be enrolled and randomized equally to receive either PCV13 or AFX3772 at different dose levels approved for evaluation in Part 2.

NCT ID: NCT05380193 Recruiting - Pneumonia Clinical Trials

Serotype Distribution in Hospitalized Adult With Pneumococcal Community Acquired Pneumonia in France

CAP'Hospi
Start date: May 9, 2022
Phase:
Study type: Observational

CAP'Hospi is an observational, multicentric study in France which primary objective is to describe the proportion of Community Acquired Pneumonia due to serotypes included in PCV20 among adults hospitalized for CAP

NCT ID: NCT05145101 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Pneumococcal Vaccination in Patients With Chronic Lymphocytic Leukaemia

Pneumo-CLL
Start date: May 7, 2020
Phase:
Study type: Observational

In this study the antibody response after vaccination with the 13-valent pneumococcal conjugated vaccine (PCV13) followed 2 months later by the 23-valent polysaccharide vaccine (PPSV23) in adults with chronic lymphocytic leukemia will be investigated.

NCT ID: NCT05092386 Recruiting - Clinical trials for Pneumococcal Infections

Safety and Immunogenicity Study of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine

Start date: January 3, 2023
Phase: Phase 1
Study type: Interventional

This study is an open-label combined randomized double-blind, positive control phase Ⅰ clinical trial of the a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to preliminary evaluate the safety and immunogenicity of the study vaccine

NCT ID: NCT05060146 Recruiting - Clinical trials for Streptococcus Pneumoniae Infection

Prevention of Pneumococcal Infections: Impact Collaborative Medico-pharmaceutical Care Structured to Improve Vaccination Coverage of Patients at Risk.

OPTIVACC
Start date: September 19, 2022
Phase: N/A
Study type: Interventional

In France, Streptococcus pneumoniae is the leading agent bacterial involved in community lung disease and meningitis. The frequency of these infections and their mortality increase significantly in those at risk such as patients with certain chronic diseases, immunocompromised or on immunosuppressive therapy. This population, despite regular monitoring, has a limited pneumococcal vaccine coverage of around 20%. By carrying out a reconciliation of treatments upon admission to hospital, the clinical pharmacist can detect those without up to date pneumococcal vaccination status. The goal of this management is to make the patient aware of the need for vaccination and organization upon return home. Thus, this limited pneumococcal vaccination coverage would benefit from intervention by regional clinical pharmacy activities. The study investigators want to study the impact of a structured medico-pharmaceutical collaboration on pneumococcal vaccination of patients with risk on discharge from hospital. The investigators hypothesize that this collaboration in patients at risk of infection with pneumococcus could significantly increase their anti-pneumococcal vaccination coverage

NCT ID: NCT04944719 Recruiting - Clinical trials for Community-acquired Pneumonia

Pneumococcal Nasopharyngeal Colonization as Predictor of Community-Acquired Pneumonia (CAP) in Adults With Chronic Diseases.

CAP
Start date: December 1, 2020
Phase:
Study type: Observational [Patient Registry]

Streptococcus pneumoniae (pneumococcus) is a commensal bacterium, often isolated in the nasopharynx of preschool children and older adults with weakened immune systems, a pathogen that remains the leading cause of Community-Acquired Pneumonia (CAP) and invasive pneumococcal disease (IPD) such as Sepsis and Meningitis. CAP is the sixth leading cause of overall mortality and the first cause of infectious disease in Colombia and the world (Montúfar et al, 2013; GBD, 2016; WHO, 2018), and both its incidence and prevalence have remained stable over the past 3 decades. Likewise, CAP due to S. pnemoniae is the most common cause of lower respiratory tract infections in humans worldwide and is associated with high morbidity and mortality in patients who suffer from it. Pneumococcus frequently colonizes the nasopharynx of children and adults and, therefore, this condition has been postulated as a risk factor for the development of CAP. There are reports of the effect of nasopharyngeal colonization in infants, but the implications of this colonization in adults, especially adults with chronic comorbidities, are not known. Additionally, several studies point to a relationship between pathogenicity, colonization capacity, and disease severity according to the infecting pneumococcal serotype. Therefore, it is not known which pneumococcal serotypes are most frequently colonized by adults with chronic diseases (cardiovascular disease (CVD), chronic obstructive pulmonary disease (COPD), renal disease (RHD), rheumatological disease (MDR), Diabetes Mellitus (DM), among others) and the potential clinical implications of this colonization. For these reasons, this research aims to study the phenomenon of colonization by pneumococcus in patients with chronic diseases for the development of CAP, and the relationship between the virulence genes of different serotypes and the outcome in invasive pneumococcal disease (IPD). This study is based on real evidence (from clinical practice) and translational medicine, is prospective-observational, multicenter and cohort type in consecutive patients. Thus, in a first phase the clinical observation of the subjects will be carried out, a second phase of follow-up and sampling in the patients, and a third phase of molecular analysis.

NCT ID: NCT04875819 Recruiting - Hiv Clinical Trials

Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV

MENPI
Start date: April 28, 2021
Phase: Phase 4
Study type: Interventional

MENPI is an investigator-initiated single-centre randomized controlled trial which aims to assess the efficacy and safety of meningococcal and pneumococcal vaccination in adults living with HIV receiving antiretroviral treatment. Participants are randomized 1:1 to either a two-dose Menveo® and Bexsero® regimen or a Prevenar13®/Pneumovax23® prime-boost regimen at day 0 and day 60 and cross over on day 90. All participants will follow an identical follow up program including plasma collection, pharyngeal swab, and adverse event registration. Immunogenicity will be determined on venous blood sampled at 30 days post-vaccination and yearly for five years.

NCT ID: NCT04664556 Recruiting - Mortality Clinical Trials

Invasive Pneumococcal Disease Study

Start date: December 13, 2010
Phase:
Study type: Observational

After 7 then 13 valent pneumococcal conjugate vaccine implementation in France in children, we will evaluate the impact of this vaccination on invasive pneumococcal disease (IPD). We will describe the clinical characteristics of IPD, pneumococcus serotyping, underlying conditions and vaccination status.

NCT ID: NCT04447521 Recruiting - Pneumonia Clinical Trials

Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium

STREPTO
Start date: September 1, 2020
Phase:
Study type: Observational

The investigators will conduct a prospective observational study of non-invasive S. pneumoniae infections in Belgium and characterize serotype distributions to evaluate national vaccination programs.

NCT ID: NCT04214444 Recruiting - Clinical trials for Pneumococcal Infections

Evaluation of Prime-boost Anti-pneumococcal Vaccination in Patients With Diffuse Large B Cell Lymphoma Treated With Rituximab

EVAPOR
Start date: July 3, 2020
Phase: Phase 3
Study type: Interventional

Pneumococcal infections remain frequent and potentially fatal. To prevent them, two anti-pneumococcal vaccines exist: a 13-valent conjugate vaccine (Prevenar®) and a 23-valent polysaccharide vaccine (Pneumovax®). For their utilization, several studies approved a prime-boost strategy. It consist two administer Pneumovax® at least two months later than Prevenar®. Patients with diffuse large B-cell Lymphoma (DLBCL) have a higher-risk to develop a pneumococcal infection. The main reason is immunosuppression, induced by rituximab (B cell depletion), chemotherapy and lymphoma. Patients are treated by immunochemotherapy, combining rituximab (anti-CD20 monoclonal antibody) and conventional chemotherapy (CHOP). However, those patients have a low rate of vaccination (about 15%).