Federico Martinón-Torres1, Hanna Czajka2, Kimberly J Center3, Jacek Wysocki4, Ewa Majda-Stanislawska5, Felix Omeñaca6, Enrique Bernaola Iturbe7, Daniel Blazquez Gamero8, Ana Concheiro-Guisán9, Francisco Gimenez-Sanchez10, Leszek Szenborn11, Peter C Giardina12, Scott Patterson3, William C Gruber12, Daniel A Scott12, Alejandra Gurtman12. 1. Translational Pediatrics and Infectious Diseases, Pediatrics Department, Hospital Clínico Universitario de Santiago de Compostela and Vaccine Research Unit, Genetics, Vaccines, Infections and Pediatrics Research Group (GENVIP), Healthcare Research Institute of Santiago, Santiago de Compostela, Spain; federico.martinon.torres@sergas.es. 2. Wojewodzki Specjalistyczny Szpital Dzieciecy im. sw. Ludwika-Regional Infectious Diseases Outpatient Clinic, Krakow, Poland; 3. Pfizer Inc, Collegeville, Pennsylvania; 4. Poznań University of Medical Sciences, Poznań, Poland; 5. Medical University of Lodz, Lodz, Poland; 6. Hospital Infantil La Paz, Madrid, Spain; 7. Servicio de Pediatría y Unidad de Investigación en Vacunas Fundación Miguel Servet Complejo Hospitalario de Navarra, Pamplona, Spain; 8. Pediatric Infectious Diseases and Immunodeficiencies Unit, Hospital Universitario 12 de Octubre, Madrid, Spain; 9. Complexo Hospitalario Universitario de Vigo, Vigo, Spain; 10. Hospital Torrecardenas, Almeria, Spain; 11. Department of Pediatric Infectious Diseases, Medical University, Wroclaw, Poland; and. 12. Pfizer Inc, Pearl River, New York.
Abstract
OBJECTIVES: This study evaluated the immune response and safety profile of 13-valent pneumococcal conjugate vaccine (PCV13) in preterm infants compared with term infants. METHODS: This Phase IV, open-label, 2-arm, multicenter, parallel-group study enrolled 200 healthy infants (preterm, n = 100; term, n = 100) aged 42 to 98 days. All subjects received PCV13 at ages 2, 3, 4 (infant series), and 12 (toddler dose [TD]) months, together with routine vaccines (diphtheria-tetanus-acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b vaccine and meningococcal group C conjugate vaccine). RESULTS: Most subjects achieved an anticapsular immunoglobulin G (IgG) antibody concentration ≥ 0.35 μg/mL for all serotypes: >85% after the infant series (except preterm infants for serotypes 5, 6A, and 6B) and >97% after TD (except for serotype 3). Preterm infants had overall lower IgG geometric mean concentrations compared with term infants; however, geometric mean fold increases after TD were similar for all serotypes. Opsonophagocytic activity results were consistent with IgG results and titers increased after TD in both groups for all serotypes, including serotype 3. PCV13 was generally well tolerated, with similar safety profiles in all preterm subgroups. CONCLUSIONS:Immune responses were lower in preterm infants than in term infants. However, the majority of subjects in both groups achieved both pneumococcal serotype-specific IgG antibody levels after the infant series that exceeded the World Health Organization-established threshold of protection and functional antibody responses. Responses were uniformly higher after TD, reinforcing the importance of a timely booster dose. PCV13 was well tolerated regardless of gestational age.
RCT Entities:
OBJECTIVES: This study evaluated the immune response and safety profile of 13-valent pneumococcal conjugate vaccine (PCV13) in preterm infants compared with term infants. METHODS: This Phase IV, open-label, 2-arm, multicenter, parallel-group study enrolled 200 healthy infants (preterm, n = 100; term, n = 100) aged 42 to 98 days. All subjects received PCV13 at ages 2, 3, 4 (infant series), and 12 (toddler dose [TD]) months, together with routine vaccines (diphtheria-tetanus-acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b vaccine and meningococcal group C conjugate vaccine). RESULTS: Most subjects achieved an anticapsular immunoglobulin G (IgG) antibody concentration ≥ 0.35 μg/mL for all serotypes: >85% after the infant series (except preterm infants for serotypes 5, 6A, and 6B) and >97% after TD (except for serotype 3). Preterm infants had overall lower IgG geometric mean concentrations compared with term infants; however, geometric mean fold increases after TD were similar for all serotypes. Opsonophagocytic activity results were consistent with IgG results and titers increased after TD in both groups for all serotypes, including serotype 3. PCV13 was generally well tolerated, with similar safety profiles in all preterm subgroups. CONCLUSIONS: Immune responses were lower in preterm infants than in term infants. However, the majority of subjects in both groups achieved both pneumococcal serotype-specific IgG antibody levels after the infant series that exceeded the World Health Organization-established threshold of protection and functional antibody responses. Responses were uniformly higher after TD, reinforcing the importance of a timely booster dose. PCV13 was well tolerated regardless of gestational age.
Authors: Elsbeth D M Rouers; Patricia C J Bruijning-Verhagen; Pieter G M van Gageldonk; Josephine A P van Dongen; Elisabeth A M Sanders; Guy A M Berbers Journal: JAMA Date: 2020-09-15 Impact factor: 56.272