Richard N Greenberg1, Alejandra Gurtman2, Robert W Frenck3, Cynthia Strout4, Kathrin U Jansen5, James Trammel6, Daniel A Scott7, Emilio A Emini8, William C Gruber9, Beate Schmoele-Thoma10. 1. University of Kentucky School of Medicine, Department of Medicine, Room MN-663, 800 Rose Street, Lexington, KY 40536-0084, United States. Electronic address: rngree01@uky.edu. 2. Pfizer Vaccines Research, Pfizer Inc., 401 N Middletown Road, Pearl River, NY 10965, United States. Electronic address: alejandra.gurtman@pfizer.com. 3. Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, MLC 6014, Cincinnati, OH, United States. Electronic address: robert.frenck@cchmc.org. 4. Coastal Carolina Research Center, 1156 Bowman Road, Suite 102, Mount Pleasant, SC, United States. Electronic address: cstrout@coastalcarolinaresearch.com. 5. Pfizer Vaccines Research, Pfizer Inc., 401 N Middletown Road, Pearl River, NY 10965, United States. Electronic address: kathrin.jansen@pfizer.com. 6. inVentiv Health Clinical, LLC, 504 Carnegie Center, Princeton, NJ, United States. Electronic address: james.trammel@inventivhealth.com. 7. Pfizer Vaccines Research, Pfizer Inc., 401 N Middletown Road, Pearl River, NY 10965, United States. Electronic address: dan.scott@pfizer.com. 8. Pfizer Vaccines Research, Pfizer Inc., 401 N Middletown Road, Pearl River, NY 10965, United States. Electronic address: emilio.emini@pfizer.com. 9. Pfizer Vaccines Research, Pfizer Inc., 401 N Middletown Road, Pearl River, NY 10965, United States. Electronic address: bill.gruber@pfizer.com. 10. Pfizer Vaccines Research, Pfizer Pharma GmbH, Linkstrasse 10, 10785 Berlin, Germany. Electronic address: beate.schmoele-thoma@pfizer.com.
Abstract
BACKGROUND: Unlike free pneumococcal polysaccharide vaccines (PPSVs), pneumococcal conjugate vaccines (PCVs) induce a T-cell-dependent immune response. The study assessed potential influence of initial 13-valent PCV (PCV13) or 23-valent PPSV (PPSV23) on subsequent vaccine administrations. METHODS: We conducted a randomized, modified double-blind study in 720 pneumococcal vaccine-naïve adults 60-64 years of age. Subjects received either PCV13 at year 0 and PCV13 at year 1; PCV13 at year 0 and PPSV23 at year 1; or PPSV23 at year 0 and PCV13 at year 1. Antipneumococcal opsonophagocytic activity (OPA) titers were measured before and 1 month after each vaccination. RESULTS:OPA titers following PPSV23 given 1 year after PCV13 (PCV13/PPSV23) (a) were noninferior for the 12 common serotypes and significantly higher for 6 of 12 common serotypes than those following only an initial PPSV23; and (b) were significantly higher for 11 of 12 common serotypes compared with PPSV23 followed by PCV13 (PPSV23/PCV13). In addition, PPSV23 followed 1 year later by PCV13 (PPSV23/PCV13) elicited significantly lower OPA titers than after only an initial dose of PCV13 for all 13 serotypes. Responses after a second vaccination with either PCV13 (PCV13/PCV13) or PPSV23 (PCV13/PPSV23) were noninferior for 9 of 13 and 8 of 12 common serotypes compared with the initial PCV13 dose. CONCLUSION: In pneumococcal vaccine-naïve adults 60-64 years of age, an initial PCV13 augmented the antipneumococcal response to subsequent administration of PPSV23 for many of the serotypes in common to both vaccines. In contrast, an initial PPSV23 resulted in a diminished response to subsequent administration of PCV13 for all serotypes. With a relatively short 1-year interval between doses, responses after a second vaccination with PCV13 (PCV13/PCV13) or PPSV23 (PCV13/PPSV23) were noninferior for a majority of serotypes compared with the initial PCV13 dose, probably reflecting the need for a longer interval between vaccine administrations. ClinicalTrials.gov Identifier: NCT00574548.
RCT Entities:
BACKGROUND: Unlike free pneumococcal polysaccharide vaccines (PPSVs), pneumococcal conjugate vaccines (PCVs) induce a T-cell-dependent immune response. The study assessed potential influence of initial 13-valent PCV (PCV13) or 23-valent PPSV (PPSV23) on subsequent vaccine administrations. METHODS: We conducted a randomized, modified double-blind study in 720 pneumococcal vaccine-naïve adults 60-64 years of age. Subjects received either PCV13 at year 0 and PCV13 at year 1; PCV13 at year 0 and PPSV23 at year 1; or PPSV23 at year 0 and PCV13 at year 1. Antipneumococcal opsonophagocytic activity (OPA) titers were measured before and 1 month after each vaccination. RESULTS: OPA titers following PPSV23 given 1 year after PCV13 (PCV13/PPSV23) (a) were noninferior for the 12 common serotypes and significantly higher for 6 of 12 common serotypes than those following only an initial PPSV23; and (b) were significantly higher for 11 of 12 common serotypes compared with PPSV23 followed by PCV13 (PPSV23/PCV13). In addition, PPSV23 followed 1 year later by PCV13 (PPSV23/PCV13) elicited significantly lower OPA titers than after only an initial dose of PCV13 for all 13 serotypes. Responses after a second vaccination with either PCV13 (PCV13/PCV13) or PPSV23 (PCV13/PPSV23) were noninferior for 9 of 13 and 8 of 12 common serotypes compared with the initial PCV13 dose. CONCLUSION: In pneumococcal vaccine-naïve adults 60-64 years of age, an initial PCV13 augmented the antipneumococcal response to subsequent administration of PPSV23 for many of the serotypes in common to both vaccines. In contrast, an initial PPSV23 resulted in a diminished response to subsequent administration of PCV13 for all serotypes. With a relatively short 1-year interval between doses, responses after a second vaccination with PCV13 (PCV13/PCV13) or PPSV23 (PCV13/PPSV23) were noninferior for a majority of serotypes compared with the initial PCV13 dose, probably reflecting the need for a longer interval between vaccine administrations. ClinicalTrials.gov Identifier: NCT00574548.
Authors: Christine Juergens; Pierre J T de Villiers; Keymanthri Moodley; Deepthi Jayawardene; Kathrin U Jansen; Daniel A Scott; Emilio A Emini; William C Gruber; Beate Schmoele-Thoma Journal: Hum Vaccin Immunother Date: 2014-02-27 Impact factor: 3.452
Authors: Bhagirath B Solanki; Christine Juergens; Manojkumar B Chopada; Pravin Supe; Vani Sundaraiyer; Natacha Le Dren-Narayanin; Mark W Cutler; William C Gruber; Daniel A Scott; Beate Schmoele-Thoma Journal: Hum Vaccin Immunother Date: 2017-09-02 Impact factor: 3.452