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Pneumonia, Pneumococcal 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: NCT05361499 Completed - Clinical trials for Streptococcus Pneumoniae Infection

A Controlled Human Pneumococcal Infection Model (PIM) Study

PIM
Start date: May 31, 2022
Phase: N/A
Study type: Interventional

Infection with Streptococcus pneumoniae (the pneumococcus) is the leading cause of pneumonia, bacterial meningitis and bacteraemia worldwide in the very young and the elderly. Although pneumococcal vaccines exist, they do not provide complete protection and new strategies to combat this pathogen are urgently needed. Asymptomatic infection of S. pneumoniae in the human nasopharynx precedes the development of pneumococcal disease. Previously, an Experimental Human Pneumococcal Carriage (EHPC) model has been developed at the Liverpool School of Tropical Medicine (LSTM). The current study entails to establish this model in healthy adults living in the Netherlands using the inoculation dose currently used at LSTM. Healthy adult participants (M/F) will be inoculated intranasally with strain BHN418, a penicillin sensitive serotype 6B strain of S. pneumoniae that was previously isolated from a healthy carrier. Following inoculation, participants will be monitored and blood and nasal samples will be collected over a period of 28 ± 3 days. Participants will receive a course of amoxicillin to eradicate infection on or shortly after the last visit at day 28 ± 3, unless S. pneumoniae is not detected on both day 14 and 28 ± 3 post-inoculation.

NCT ID: NCT05183854 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Pneumococcal Pneumonia Vaccine Series (PCV20 and PPSV23) in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency, PROTECT CLL Trial

Start date: January 7, 2022
Phase: Phase 2
Study type: Interventional

This phase II trial tests whether the pneumococcal pneumonia vaccine series (PCV20 and PPSV23) works to mount an effective immune response in patients with chronic lymphocytic leukemia. PCV20 and PPSV23 are both vaccines that protect against bacteria that cause pneumococcal disease. Giving these vaccinations as series may make a stronger immune response and prevent against pneumococcal infections in patients with chronic lymphocytic leukemia.

NCT ID: NCT05173727 Completed - Clinical trials for Pneumonia, Bacterial

Prevalence and Serotype of Streptococcus Pneumoniae Hospitalized Adult With Community-Acquired Pneumonia

HACAP
Start date: May 15, 2022
Phase:
Study type: Observational

Streptococcus Pneumoniae is one of the etiology in severe CAP and accounts for about 60-75% of cases and is likely to be the leading cause of unknown etiologic pneumonia. In Indonesia, studies regarding the prevalence of Streptococcus pneumoniae as the cause of CAP are still very rare. Therefore, there is still a need for further investigation in S. pneumoniae prevalence among hospitalized CAP by utilizing different detection methods in Indonesia. Antibiotics as a therapy of CAP also showed high levels of resistance, meanwhile, early detection of causative pathogen is potentially reducing the incidence of antibiotic resistance and usage of broad-spectrum antibiotics.

NCT ID: NCT05140720 Not yet recruiting - Clinical trials for Vaccine Preventable Disease

Assess the Safety and Immunogenicity of PNEUMOSIL® Vaccine in Healthy Vietnamese Children, 6 Weeks to 24 Months of Age

PNEUMOSIL
Start date: January 25, 2022
Phase: N/A
Study type: Interventional

The current study provides data necessary to evaluate the safety and immunogenicity of Serum Institute of India's PNEUMOSIL® [Pneumococcal Polysaccharide Conjugate Vaccine Adsorbed (10-Valent)] in Healthy Vietnamese Infants and Toddlers, 6 weeks to 24 months of age. This is an open label, prospective, bridging study.

NCT ID: NCT05079152 Active, not recruiting - COVID-19 Pneumonia Clinical Trials

Evaluation of Immunogenicity and Safety of Combined Immunization of COVAX (Produced in Wuhan) and PPV23 / IIV4

Start date: May 6, 2021
Phase: Phase 4
Study type: Interventional

Subjects will be recruited and divided into 3 groups: Experimental Group (468 subjects): 1st dose : combined vaccination of COVAX+PPV23, 2nd dose: combined vaccination of COVAX+IIV4; Control Group A (468 subjects): 1st dose: COVAX only, 2nd dose: COVAX only; Control Group B (468 subjects): 1st dose: PPV23 only, 2nd dose: IIV4 only. Blood samples will be collected 3 times: before the 1st dose of vaccinatioin; before the 2nd dose of vaccination; 28 days after the 2nd dose of vaccination. The immunogenicity and safety of both experimental and control groups will be analyzed.

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: NCT05017519 Not yet recruiting - Clinical trials for Respiratory Syncytial Virus Infections

Epidemiology and Household Transmission of Streptococcus Pneumoniae and Respiratory Syncytial Virus

Start date: October 1, 2021
Phase:
Study type: Observational [Patient Registry]

This household-based prospective cohort study aims to stablish the household transmission of Respiratory syncytial virus and S. pneumoniae especially in the elderly and infants/children as well as inter-relationship between S. pneumoniae and Respiratory syncytial virus.

NCT ID: NCT04974294 Recruiting - Clinical trials for Streptococcus Pneumonia

PREVENTING PNEUMOcoccal Disease Through Vaccination (Study 2)

Pneumo 2
Start date: July 28, 2021
Phase: Phase 4
Study type: Interventional

To determine the effect of PCV-13 and PPV-23 vaccination versus control on experimental pneumococcal colonisation of 2 clades of serotypes 3 and 6B at 1 month and 6 months post vaccination respectively, using the EHPC model.

NCT ID: NCT04952337 Recruiting - COVID-19 Clinical Trials

Clinical, Molecular and Functional Biomarkers for PROgnosis, Pathomechanisms and Treatment Strategies of COVID-19 (PROVID) - (PROVID-CAPNETZ)

PROVID-CAPNETZ
Start date: October 1, 2020
Phase:
Study type: Observational

The pandemic triggered by the new SARS-CoV-2 presents the German health system with previously unknown challenges. There are currently no effective therapies for the treatment of the SARS-CoV-2 lung disease Covid-19. The aim of the joint project PROVID is to draw conclusions from the often very different clinical appearance of infections with the SARS-CoV-2 pathogen in order to improve patient care through targeted clinical management. The effects of infections with the SARS-CoV-2 pathogen are wide-ranging and include a spectrum from symptomlessness to infections of the upper respiratory tract, uncomplicated but also severe pneumonia with lung failure and high mortality. PROVID will first check whether certain host factors determine the severity and / or the course of Covid-19. Research is also being carried out into whether the molecular and clinical values of Covid-19 patients differ from those of patients with pneumonia caused by other pathogens. In addition, it will be tested whether specific molecular markers describe the severity of the disease and are suitable as an aid for targeted therapy for Covid-19. PROVID is an interdisciplinary joint project made up of three sub-projects that are being implemented at three locations (Charitè-Universitätsmedizin Berlin, Universität Leipzig IMISE and CAPNETZ STIFTUNG / Hannover). PROVID is based on three clinical research platforms with a high track record in recruiting patients with high-quality data and biomaterials on the one hand and guideline-changing results on the other hand: CAPNETZ (competence network CAP, since 2002, world's largest database and biobank for CAP), PROGRESS (Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Sepsis, since 2007) and CAPSyS (systems medicine of community-acquired pneumonia, since 2014). The COVID-19 patients are recruited into 3 different patient cohorts via these 3 research platforms. 1. PROVID-CAPNETZ, 2. PROVID-PROGRESS, 3. PROVID-CAPSyS.