Streptococcus pneumoniae is a bacterium that causes invasive and non-invasive pneumococcal disease. Invasive pneumococcal disease (IPD) is defined as the existence of Streptococcus pneumoniae bacteria from a normally sterile site (e.g., blood or bodily fluids). Pneumococcal bacteremia, the presence of pneumococcal bacteria in the bloodstream can lead to serious complications. Risk factors for acquiring pneumococcal disease and/or experiencing more severe effects include those with chronic concurrent conditions such as chronic heart disease, chronic lung disease, chronic liver disease, being diabetic, alcoholism, current cigarette smoking, and asthma and those with immunocompromising conditions such as cancer.
The Joint Committee on Vaccination and Immunisation (JCVI) is the UK’s National Immunization Technical Advisory Group (NITAG). They review comprehensive evidence of and make recommendations about the use of vaccines in the country and recommend that the most at-risk adult patients receive pneumococcal vaccination at least once every 5 years to protect them from IPD.
Pneumococcal vaccine coverage among UK adults varies by age group and region. Despite JCVI’s recommendations for adult pneumococcal vaccination, many UK adults at risk for pneumococcal disease remain unvaccinated. Previous research indicates that the incidence of IPD continues to increase in the post-COVID era and pneumococcal pneumonia remains a driver of high healthcare utilization cost and clinical burden.
This study will provide an up to date and comprehensive assessment of the burden of adult pneumococcal disease in England and examine all the major pneumococcal disease manifestations in adults. This information will support the development of interventions for vaccine-preventable disease.
Streptococcus pneumoniae is an encapsulated gram-positive bacterium that causes invasive and non-invasive pneumococcal disease. Invasive pneumococcal disease (IPD) is defined as isolation of S. pneumoniae from a normally sterile site (e.g., blood or cerebrospinal fluid). Complications of pneumococcal bacteremia may include arthritis, meningitis, and endocarditis.
Aside from older age (≥ 65 years), additional risk factors for acquiring pneumococcal disease (PD) and/or experiencing more severe sequelae include those with chronic comorbid conditions such as chronic heart disease, chronic lung disease, chronic liver disease, diabetes mellitus, alcoholism, current cigarette smoking, and asthma and those with immunocompromising conditions, including cancer.
Despite The Joint Committee on Vaccination and Immunisation (JCVI) recommendations for adult pneumococcal vaccination, many UK adults at risk for pneumococcal disease remain unvaccinated. Previous research indicates that the incidence of IPD continues to increase in the post-COVID era and pneumococcal pneumonia remains a driver of high healthcare utilization cost and clinical burden. MSD have developed a 21-valent pneumococcal conjugate vaccine (V116) for the prevention of invasive disease, and non-bacteremic pneumococcal pneumonia caused by S. pneumoniae serotypes contained in the vaccine which is already approved in the US. To demonstrate the potential value of V116, it is important to quantify the residual and vaccine-preventable burden of invasive and non-invasive pneumococcal disease.
This descriptive retrospective observational cohort study aims to provide an updated and comprehensive assessment of the burden of adult PD in England in both outpatient and inpatient settings. The study will examine all the major PD manifestations in adults IPD, non-bacteremic pneumococcal pneumonia (NBPP) and all cause pneumonia (ACP). The study will also estimate healthcare resource utilization and costs associated with IPD episodes, as well as the incidence of post-IPD related sequalae. The results of this study can be combined with etiologic and serotype-specific data to inform the development of vaccine-preventable interventions.
Vaccination status (Number of patients vaccinated, Vaccination Coverage Rate), Number of patients diagnosed with Pneumococcal disease (PD) (with and with no record of a vaccination), Number of new cases of PD, Cumulative Incidence of PD (invasive pneumococcal disease (IPD), non-bacteremic pneumococcal pneumonia (NBPP), all cause pneumonia (ACP), Incidence rates of PD (IPD, NBPP, ACP), clinical outcomes (Case fatality rates (CFR) associated with PD (IPD, NBPP, ACP) admissions), Time to vaccination, healthcare resource use outcomes (GP appointments, prescriptions issued in primary care, outpatient appointments, A&E attendances, inpatient admissions, type of admission, mortality, inpatient length of stay, critical care unit (CCU) stays, inpatient HRG tariffs), cost (GP appointments, prescriptions issued in primary care, outpatient appointments, A&E attendances, inpatient admissions (All and CCU) stays), Number of IPD hospitalizations resulting in post-IPD sequelae (meningitis and sepsis), Socio-demographic and comorbidity profiles for vaccinated patients and those diagnosed with PD (Mean, median, minimum, and maximum age at vaccination or PD diagnosis, age, gender, ethnicity, BMI, total time in cohort, mean and median follow-up time, Charlson Co-morbidity Score, Geographic region) and Risk group. Proportion of patients at- high-risk of PD (age groups)
Jay Were - Chief Investigator - Parexel International Limited (UK)
Jay Were - Corresponding Applicant - Parexel International Limited (UK)
Amanda Martino - Collaborator - Merck & Co., Inc.
Ian Matthews - Collaborator - Merck & Co. Inc - Pennsylvania, USA
Mateo Delclaux Rodriguez-Rey - Collaborator - Parexel International Limited (UK)
Salini Mohanty - Collaborator - Merck & Co. Inc - Pennsylvania, USA
Sariga Kakkamani - Collaborator - Parexel International Limited (UK)
Smit Patel - Collaborator - Merck and Company, Incorporated
Xinyu Yang - Collaborator - Parexel International Limited (UK)
Yi Zheng - Collaborator - Merck Sharp & Dohme LLC
Yi-Ling Huang - Collaborator - Merck & Co., Inc.
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation