دورية أكاديمية
أعرض في EDS

Safety and immunogenicity of the Cuban heptavalent pneumococcal conjugate vaccine in healthy infants. Results from a double-blind randomized control trial Phase I.

التفاصيل البيبلوغرافية
العنوان: Safety and immunogenicity of the Cuban heptavalent pneumococcal conjugate vaccine in healthy infants. Results from a double-blind randomized control trial Phase I.
المؤلفون: Martínez CPD; Children University Hospital 'Juan Manuel Márquez', Marianao, Havana 11400, Cuba. Electronic address: carlos.dotres@nauta.cu., Linares-Pérez N; Finlay Vaccine Institute, 200 and 21 Street, Playa, Havana 11600, Cuba. Electronic address: nlinares@finlay.edu.cu., Toledo-Romaní ME; Tropical Medicine Institute 'Pedro Kourí', Havana, Cuba. Electronic address: mariaeugenia@ipk.edu.cu., Delgado YR; University Hospital 'Juan Manuel Márquez', Marianao, Havana, Cuba. Electronic address: yariricardo@infomed.sld.cu., Gómez RP; Children University Hospital 'Juan Manuel Márquez', Marianao, Havana 11400, Cuba. Electronic address: puga@infomed.sld.cu., Moreno BP; Finlay Vaccine Institute, 200 and 21 Street, Playa, Havana 11600, Cuba. Electronic address: bparedes@finlay.edu.cu., Rodriguez-Noda LM; Finlay Vaccine Institute, 200 and 21 Street, Playa, Havana 11600, Cuba. Electronic address: lmrodriguez@finlay.edu.cu., Sosa MM; Finlay Vaccine Institute, 200 and 21 Street, Playa, Havana 11600, Cuba. Electronic address: mmirabal@finlay.edu.cu., Mederos DS; Finlay Vaccine Institute, 200 and 21 Street, Playa, Havana 11600, Cuba. Electronic address: dsantana@finlay.edu.cu., García-Rivera D; Finlay Vaccine Institute, 200 and 21 Street, Playa, Havana 11600, Cuba. Electronic address: dagarcia@finlay.edu.cu., Valdés-Balbín Y; Finlay Vaccine Institute, 200 and 21 Street, Playa, Havana 11600, Cuba. Electronic address: yvbalbin@finlay.edu.cu., Goldblatt D; World Health Organization (WHO) Pneumococcal Serology Reference Laboratory, University College London, Institute of Child Health, London, United Kingdom. Electronic address: d.goldblatt@ucl.ac.uk., Vérez-Bencomo V; Finlay Vaccine Institute, 200 and 21 Street, Playa, Havana 11600, Cuba. Electronic address: vicente.verez@finlay.edu.cu.
مؤلفون مشاركون: Havana-Pneumococci Clinical Group, Finlay-Pneumococci Project
المصدر: Vaccine [Vaccine] 2018 Aug 06; Vol. 36 (32 Pt B), pp. 4944-4951. Date of Electronic Publication: 2018 Jul 10.
نوع المنشور: Clinical Trial, Phase I; 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: Heptavalent Pneumococcal Conjugate Vaccine/*therapeutic use , Pneumococcal Infections/*prevention & control , Vaccines, Conjugate/*therapeutic use, Antibodies, Bacterial/immunology ; Double-Blind Method ; Female ; Heptavalent Pneumococcal Conjugate Vaccine/administration & dosage ; Humans ; Immunization Schedule ; Infant ; Male ; Pneumococcal Infections/immunology ; Vaccines, Conjugate/administration & dosage
مستخلص: Background: Cuba has a new pneumococcal conjugate vaccine candidate (PCV7-TT). This study evaluates the safety and immunogenicity in healthy infants using 2p+1 vaccination schedule.
Methods: A phase I, controlled, randomized and double blind clinical trial was designed. 30 unvaccinated healthy infants were included. 20 subjects were assigned to study group (PCV7-TT) and 10 to control group (Synflorix®) to receive the vaccines at 7, 8 months of age (primary series) and 11 months (booster dose). Blood samples were collected 30 days after second dose and post booster for antibodies measure analysis by ELISA and OPA. The statistics analysis included the frequency of occurrence for adverse events and the immune response. Non-parametric tests were used to compare the immune response. The clinical trial was published in the Cuban Public Register of Clinical Trials with code RPCEC00000173 available at http://registroclinico.sld.cu.
Results: Overall, the safety profile of PCV7-TT was similar to Synflorix®. Local reactions were predominant and systemic events were mild in severity. Swelling and redness were frequently associated with PCV7-TT mainly after the first dose (50% and 40% respectively). 15% and 10% of subject reported severe swelling after first dose with PCV7-TT and after second dose with Synflorix®. Mild fever (≥38-≤39), vomiting and sleep disturb were the systemic events reported. 100% of infants achieved pneumococcal IgG antibody concentrations ≥0.35 µg/ml after booster dose for serotypes 1, 14, 18C and 19F in each vaccine group. For serotypes 5, 6B and 23F, more than 80% infants vaccinated with Synflorix® or PCV7-TT achieved protective IgG GMC ≥ 0.35 µg/ml after booster dose. OPA proportion's responders to the seven common serotypes were 89.5% or more after the primary dose and 100% after booster dose in vaccinated with PCV7-TT.
Conclusions: The Cuban PCV7-TT is safe, well tolerated and immunogenic in healthy infants.
(Copyright © 2018 Elsevier Ltd. All rights reserved.)
فهرسة مساهمة: Investigator: CR Ruiz, Children University Hospital 'Juan Manuel Márquez', Marianao, Havana 11400, Cuba.; Y García, Children University Hospital 'Juan Manuel Márquez', Marianao, Havana 11400, Cuba.; R Del Valle-Rodríguez, Children University Hospital 'Juan Manuel Márquez', Marianao, Havana 11400, Cuba.; A Rodríguez-Concepción, Children University Hospital 'Juan Manuel Márquez', Marianao, Havana 11400, Cuba.; D Vega, Children University Hospital 'Juan Manuel Márquez', Marianao, Havana 11400, Cuba.; ME Mesa, Children University Hospital 'Juan Manuel Márquez', Marianao, Havana 11400, Cuba.; JA Broche, Children University Hospital 'Juan Manuel Márquez', Marianao, Havana 11400, Cuba.; A Pérez, Finlay Vaccine Institute, 200 and 21 Street, Playa, Havana 11600, Cuba.; V Echemendía, Finlay Vaccine Institute, 200 and 21 Street, Playa, Havana 11600, Cuba.; M Martínez, Finlay Vaccine Institute, 200 and 21 Street, Playa, Havana 11600, Cuba.; P Cabrera, Finlay Vaccine Institute, 200 and 21 Street, Playa, Havana 11600, Cuba.; N Nuñez, Finlay Vaccine Institute, 200 and 21 Street, Playa, Havana 11600, Cuba.; A Iglesias, Finlay Vaccine Institute, 200 and 21 Street, Playa, Havana 11600, Cuba.; Y Rodríguez, Finlay Vaccine Institute, 200 and 21 Street, Playa, Havana 11600, Cuba.; N González, Finlay Vaccine Institute, 200 and 21 Street, Playa, Havana 11600, Cuba.; M Armesto, Finlay Vaccine Institute, 200 and 21 Street, Playa, Havana 11600, Cuba.; A Álvarez, Finlay Vaccine Institute, 200 and 21 Street, Playa, Havana 11600, Cuba.
Keywords: Clinical trial; Cuban; Immunogenicity; Infant; Pneumococcal conjugate vaccine; Safety
المشرفين على المادة: 0 (Antibodies, Bacterial)
0 (Heptavalent Pneumococcal Conjugate Vaccine)
0 (Vaccines, Conjugate)
تواريخ الأحداث: Date Created: 20180715 Date Completed: 20181022 Latest Revision: 20181022
رمز التحديث: 20231215
DOI: 10.1016/j.vaccine.2018.05.027
PMID: 30005948
قاعدة البيانات: MEDLINE
الوصف
تدمد:1873-2518
DOI:10.1016/j.vaccine.2018.05.027