دورية أكاديمية
أعرض في EDS

Immunogenicity of pneumococcal conjugate vaccine formulations containing pneumococcal proteins, and immunogenicity and reactogenicity of co-administered routine vaccines - A phase II, randomised, observer-blind study in Gambian infants.

التفاصيل البيبلوغرافية
العنوان: Immunogenicity of pneumococcal conjugate vaccine formulations containing pneumococcal proteins, and immunogenicity and reactogenicity of co-administered routine vaccines - A phase II, randomised, observer-blind study in Gambian infants.
المؤلفون: Odutola A; Vaccines & Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul, Gambia. Electronic address: aderonke.odutola@lshtm.ac.uk., Ota MOC; Vaccines & Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul, Gambia. Electronic address: martin.x.ota@gsk.com., Antonio M; Vaccines & Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul, Gambia. Electronic address: mantonio@mrc.gm., Ogundare EO; Vaccines & Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul, Gambia. Electronic address: tundeyogundare@yahoo.com., Saidu Y; Vaccines & Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul, Gambia. Electronic address: ysaidu@clintonhealthaccess.org., Owiafe PK; Vaccines & Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul, Gambia. Electronic address: pkowiafe@uhas.edu.gh., Worwui A; Vaccines & Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul, Gambia. Electronic address: aworwui@mrc.gm., Idoko OT; Vaccines & Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul, Gambia. Electronic address: oidoko@mrc.gm., Owolabi O; Vaccines & Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul, Gambia. Electronic address: oowolabi@mrc.gm., Kampmann B; Vaccines & Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul, Gambia; Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK. Electronic address: bkampmann@mrc.gm., Greenwood BM; Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK. Electronic address: Brian.Greenwood@lshtm.ac.uk., Alderson M; PATH, Seattle, WA, USA. Electronic address: malderson@path.org., Traskine M; GSK, Wavre, Belgium. Electronic address: magali.x.traskine@gsk.com., Swinnen K; GSK, Wavre, Belgium. Electronic address: kristien.m.swinnen@gsk.com., Verlant V; GSK, Wavre, Belgium. Electronic address: vincent.verlant@gsk.com., Dobbelaere K; GSK, Wavre, Belgium. Electronic address: dobbelaerekurt@gmail.com., Borys D; GSK, Wavre, Belgium. Electronic address: dorota.d.borys@gsk.com.
المصدر: Vaccine [Vaccine] 2019 May 01; Vol. 37 (19), pp. 2586-2599. Date of Electronic Publication: 2019 Apr 08.
نوع المنشور: Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Elsevier Science Country of Publication: Netherlands NLM ID: 8406899 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-2518 (Electronic) Linking ISSN: 0264410X NLM ISO Abbreviation: Vaccine Subsets: MEDLINE
أسماء مطبوعة: Publication: Amsterdam, The Netherlands : Elsevier Science
Original Publication: [Guildford, Surrey, UK] : Butterworths, [c1983-
مواضيع طبية MeSH: Immunogenicity, Vaccine*, Pneumococcal Infections/*prevention & control , Pneumococcal Vaccines/*immunology , Streptococcus pneumoniae/*immunology , Vaccines, Conjugate/*immunology, Age Factors ; Antibodies, Bacterial/immunology ; Antibody Specificity/immunology ; Antigens, Bacterial/immunology ; Bacterial Proteins/immunology ; Female ; Gambia/epidemiology ; Humans ; Immunization Schedule ; Infant ; Male ; Serogroup
مستخلص: Background: Two conserved pneumococcal proteins, pneumolysin toxoid (dPly) and pneumococcal histidine triad protein D (PhtD), combined with 10 polysaccharide conjugates from the pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) in two investigational pneumococcal vaccine (PHiD-CV/dPly/PhtD) formulations were immunogenic and well-tolerated when administered to Gambian children. Here, we report immunogenicity of the polysaccharide conjugates, and immunogenicity and reactogenicity of co-administered routine vaccines.
Methods: In this phase II, controlled, observer-blind, single-centre study, healthy infants aged 8-10 weeks were randomised (1:1:1:1:1:1) to six groups. Four groups received 3+0 schedule (2-3-4 months [M]) of PHiD-CV/dPly/PhtD (10 or 30 µg of each protein), PHiD-CV, or 13-valent pneumococcal conjugate vaccine; and two groups received 2+1 schedule (2-4-9 M) of PHiD-CV/dPly/PhtD (30 µg of each protein) or PHiD-CV. All infants received diphtheria-tetanus-whole cell pertussis-hepatitis B-Haemophilus influenzae type b (DTPw-HBV/Hib) and oral trivalent polio vaccines (OPV) at 2-3-4 M, and measles, yellow fever, and OPV vaccines at 9 M. We evaluated immune responses at 2-5-9-12 M; and reactogenicity 0-3 days post-vaccination.
Results: 1200 infants were enrolled between June 2011 and May 2012; 1152 completed the study. 1 M post-primary vaccination, for each PHiD-CV serotype except 6B and 23F, ≥97.4% (3+0 schedule) and ≥96.4% (2+1 schedule) of infants had antibody concentrations ≥0.2 μg/mL. Immune responses were comparable between groups within the same vaccination schedules. Observed antibody geometric mean concentrations (GMCs) increased by 1 M post-primary vaccination compared to pre-vaccination. In the following months, GMCs and opsonophagocytic activity titres waned, with an increase post-booster for the 2+1 schedule. Immune responses to protein D and, DTPw-HBV/Hib, OPV, measles, and yellow fever vaccines were not altered by co-administration with pneumococcal proteins. Reactogenicity of co-administered vaccines was comparable between groups and did not raise concerns.
Conclusion: Immune responses to the 10 PHiD-CV polysaccharide conjugates and co-administered vaccines were not altered by addition of dPly and PhtD. ClinicalTrials.gov identifier NCT01262872.
(Copyright © 2019 GlaxoSmithKline Biologicals SA. Published by Elsevier Ltd.. All rights reserved.)
فهرسة مساهمة: Keywords: Immunogenicity; Paediatric vaccination; Pneumococcal protein-containing vaccine; Pneumococcal serotype-specific polysaccharide; Streptococcus pneumoniae
سلسلة جزيئية: ClinicalTrials.gov NCT01262872
المشرفين على المادة: 0 (Antibodies, Bacterial)
0 (Antigens, Bacterial)
0 (Bacterial Proteins)
0 (Pneumococcal Vaccines)
0 (Vaccines, Conjugate)
تواريخ الأحداث: Date Created: 20190413 Date Completed: 20200903 Latest Revision: 20200903
رمز التحديث: 20221213
DOI: 10.1016/j.vaccine.2019.03.033
PMID: 30975570
قاعدة البيانات: MEDLINE
الوصف
تدمد:1873-2518
DOI:10.1016/j.vaccine.2019.03.033