Exploratory efficacy endpoints in the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) |
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| Affiliation: | 1. Pfizer Vaccines Clinical Research and Development, Pearl River, NY, USA;2. Pfizer Vaccines Clinical Research and Development, Maidenhead, UK;3. Pfizer Vaccines Clinical Research and Development, Collegeville, PA, USA;4. Pfizer Vaccines Clinical Research and Development, Berlin, Germany;5. Julius Center for Health Sciences and Primary Care, UMC Utrecht, Netherlands;6. Department of Respiratory Medicine, UMC Utrecht, Netherlands;1. Northern California Kaiser Permanente Vaccine Study Center, Oakland, CA, USA;2. Pfizer Vaccines, 500 Arcola Road, Collegeville, PA, USA;1. Department of Clinical Medicine, Institute of Tropical Medicine, Nagasaki University, Nagasaki, Japan;2. School of Tropical Medicine and Global Health, Nagasaki University, Nagasaki, Japan;3. Department of General Internal Medicine, Kameda Medical Center, Chiba, Japan;4. Department of Pulmonology, Kameda Medical Center, Chiba, Japan;5. Department of Internal Medicine, Juzenkai Hospital, Nagasaki, Japan;6. Department of Pulmonology, Chikamori Hospital, Kochi, Japan;7. Department of General Internal Medicine, Ebetsu City Hospital, Hokkaido, Japan;1. Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea;2. Asian Pacific Influenza Institute (APII), Korea University College of Medicine, Seoul, Republic of Korea;3. Hallym University College of Medicine, Seoul, Republic of Korea;4. St. Vincent’s Hospital, Catholic University of Korea College of Medicine, Suwon, Gyeonggi-do, Republic of Korea;1. Pediatric Infectious Disease Unit, Soroka University Medical Center and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel;2. Boston University School of Medicine, Boston, MA, USA;3. Center for Microbial Pathogenesis, The Research Institute at Nationwide Children''s Hospital, Department of Pediatrics, The Ohio State University College of Medicine, Columbus, OH, USA;4. Université Paris Est, IMRB-GRC GEMINI, and Unité Court Séjour, Petits Nourrissons, Centre Hospitalier Intercommunal de Créteil, Paris, France;1. Merck Vaccines, 770 Sumneytown Pike, WP97-B364, West Point, PA 19426, USA;2. Merck Research Laboratories, Upper Gwynedd, PA 19454, USA;1. Immunisation, Hepatitis, and Blood Safety Department, Health Protection Services, Public Health England, London, UK;2. Statistics, Modelling, and Economics Department, Health Protection Services, Public Health England, London, UK;3. Respiratory and Vaccine Preventable Bacteria Reference Unit, Microbiology Services, Public Health England, London, UK;4. Institute of Hygiene and Microbiology, University of Würzburg, Würzburg, Germany;5. School of Medicine, Griffith University, Gold Coast Campus, Southport, QLD, Australia |
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| Abstract: | BackgroundThe Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) assessed vaccine-type community-acquired pneumonia (VT-CAP) and vaccine-type invasive pneumococcal disease (VT-IPD) prevention with 13-valent pneumococcal conjugate vaccine (PCV13) in adults aged ⩾65 years. We report vaccine efficacy (VE) of PCV13 for the remaining 23 exploratory endpoints and serotype distributions for pneumococcal CAP and IPD.MethodsThis was a parallel-group, randomised, placebo-controlled, double-blind trial comparing single-dose PCV13 with placebo. Exploratory CAP endpoints included first episode of confirmed non-VT (NVT) pneumococcal CAP; all confirmed episodes of NVT pneumococcal CAP, pneumococcal CAP, nonbacteraemic/noninvasive (NB/NI) VT pneumococcal CAP, and NB/NI pneumococcal CAP; and first and all episodes of culture-confirmed VT pneumococcal CAP, culture-confirmed pneumococcal CAP, culture-confirmed NVT pneumococcal CAP, probable VT pneumococcal CAP, probable NVT pneumococcal CAP, and probable and possible pneumococcal CAP. Exploratory IPD endpoints included all episodes of VT-IPD and IPD, and first and all episodes of NVT-IPD. The per-protocol and modified intent-to-treat (mITT) populations were evaluated.ResultsIn total, 84,496 participants were enrolled. Eight of 23 exploratory CAP and IPD endpoints were statistically significant in both populations. In the per-protocol population, these included VE of 29% for all episodes of confirmed pneumococcal CAP, 43% for all NB/NI episodes of VT pneumococcal CAP, 52% for all episodes of culture-confirmed pneumococcal CAP, and 53% for all episodes of IPD. Comparable VE estimates were observed in the mITT population. The most common VT serotypes were 1 (10 first episodes of confirmed pneumococcal CAP; 2 first episodes of IPD) and 7F (22; 7) among PCV13 and placebo recipients, respectively.ConclusionsThe results of this analysis yielded statistically significant PCV13 VE for all episodes of confirmed pneumococcal CAP (including NB/NI and culture-confirmed episodes) and for all episodes of IPD in adults aged ⩾65 years. These findings are consistent with the primary efficacy analysis. ClinicalTrials.gov identifier: NCT00744263. |
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| Keywords: | Community-acquired pneumonia Invasive pneumococcal disease PCV13 Pneumococcal conjugate vaccine Vaccine efficacy Adult |
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