José A Suaya1, Qin Jiang2, Daniel A Scott3, William C Gruber4, Chris Webber5, Beate Schmoele-Thoma6, Cassandra K Hall-Murray7, Luis Jodar8, Raul E Isturiz9. 1. Pfizer Vaccines Medicines Development & Scientific and Clinical Affairs, New York, NY, USA. Electronic address: Jose.A.Suaya@pfizer.com. 2. Pfizer Vaccines Medicines Development & Scientific and Clinical Affairs, Collegeville, PA, USA. Electronic address: Qin.Jiang@pfizer.com. 3. Pfizer Vaccines Clinical Research and Development, Pearl River, NY, USA. Electronic address: Dan.Scott@pfizer.com. 4. Pfizer Vaccines Clinical Research and Development, Pearl River, NY, USA. Electronic address: Bill.Gruber@pfizer.com. 5. Pfizer Vaccines Clinical Research and Development, Pearl River, NY, USA. Electronic address: Chris.Webber@pfizer.com. 6. Pfizer Vaccines Clinical Research and Development, Berlin, Germany. Electronic address: Beate.Schmoele-Thoma@pfizer.com. 7. Pfizer Vaccines Medicines Development & Scientific and Clinical Affairs, Collegeville, PA, USA. Electronic address: Cassandra.Hall-Murray@pfizer.com. 8. Pfizer Vaccines Medicines Development & Scientific and Clinical Affairs, Collegeville, PA, USA. Electronic address: Luis.Jodar@pfizer.com. 9. Pfizer Vaccines Medicines Development & Scientific and Clinical Affairs, Collegeville, PA, USA. Electronic address: Raul.Isturiz@pfizer.com.
Abstract
BACKGROUND:Individuals with certain chronic medical conditions are at higher risk of developing pneumonia and pneumococcal disease than those without. Using data from the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), this post hoc analysis assessed the efficacy of the 13-valent pneumococcal conjugate vaccine (PCV13) in adults aged ≥65 years with at-risk conditions. METHODS: The Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) was a double-blind, parallel-group, randomized, placebo-controlled study in the Netherlands in which adults aged ≥65 years received eitherPCV13 or placebo. Outcomes of interest were identified using prespecified clinical criteria, radiographic confirmation, routine microbiologic testing, and a serotype-specific urinary antigen detection assay. In this post hoc analysis, participants were classified by at-risk status based on self-reporting of any of the following chronic medical conditions: heart disease, lung disease, asthma, diabetes, liver disease, and smoking. The objective of this analysis was to assess PCV13 vaccine efficacy (VE) against a first episode of vaccine-serotype community-acquired pneumonia (VT-CAP) in at-risk participants. RESULTS: Of the 84,496 adults enrolled in the study, 41,385 (49.2%) were considered at risk owing to chronic medical conditions. Of the 139 VT-CAP cases, 115 (82.7%) occurred in these participants. VE of PCV13 against a first episode of VT-CAP among participants with at-risk conditions was 40.3% (95.2% CI: 11.4%, 60.2%). Average duration of follow-up since vaccination was 3.95 years for at-risk participants; protection did not wane over the study period. CONCLUSIONS: This post hoc analysis of the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) showed significant and persistent efficacy of PCV13 against VT-CAP in at-risk older adults. ClinicalTrials.gov identifier: NCT00744263.
RCT Entities:
BACKGROUND: Individuals with certain chronic medical conditions are at higher risk of developing pneumonia and pneumococcal disease than those without. Using data from the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), this post hoc analysis assessed the efficacy of the 13-valent pneumococcal conjugate vaccine (PCV13) in adults aged ≥65 years with at-risk conditions. METHODS: The Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) was a double-blind, parallel-group, randomized, placebo-controlled study in the Netherlands in which adults aged ≥65 years received either PCV13 or placebo. Outcomes of interest were identified using prespecified clinical criteria, radiographic confirmation, routine microbiologic testing, and a serotype-specific urinary antigen detection assay. In this post hoc analysis, participants were classified by at-risk status based on self-reporting of any of the following chronic medical conditions: heart disease, lung disease, asthma, diabetes, liver disease, and smoking. The objective of this analysis was to assess PCV13 vaccine efficacy (VE) against a first episode of vaccine-serotype community-acquired pneumonia (VT-CAP) in at-risk participants. RESULTS: Of the 84,496 adults enrolled in the study, 41,385 (49.2%) were considered at risk owing to chronic medical conditions. Of the 139 VT-CAP cases, 115 (82.7%) occurred in these participants. VE of PCV13 against a first episode of VT-CAP among participants with at-risk conditions was 40.3% (95.2% CI: 11.4%, 60.2%). Average duration of follow-up since vaccination was 3.95 years for at-risk participants; protection did not wane over the study period. CONCLUSIONS: This post hoc analysis of the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) showed significant and persistent efficacy of PCV13 against VT-CAP in at-risk older adults. ClinicalTrials.gov identifier: NCT00744263.
Authors: Reena Shah; Catherine Gathu; Eric Njenga; Jeremiah Chakaya; Elijah Ogola; Omondi Oyoo; Andrew Odhiambo; Benjamin Wambugu; Charles Feldman Journal: Pan Afr Med J Date: 2022-01-19