دورية أكاديمية
Safety, reactogenicity and immunogenicity of a novel pneumococcal protein-based vaccine in adults : a phase I/II randomized clinical study
| العنوان: | Safety, reactogenicity and immunogenicity of a novel pneumococcal protein-based vaccine in adults : a phase I/II randomized clinical study |
|---|---|
| المؤلفون: | Leroux-Roels, Geert, Maes, Cathy, De Boever, Fien, Traskine, Magali, Rüggeberg, Jens U, Borys, Dorota |
| المصدر: | VACCINE ; ISSN: 0264-410X |
| سنة النشر: | 2014 |
| المجموعة: | Ghent University Academic Bibliography |
| مصطلحات موضوعية: | Medicine and Health Sciences, Pneumococcal protein-containing vaccine, Streptococcus pneumoniae, Pneumolysin, dPly, PhtD, ACUTE OTITIS-MEDIA, STREPTOCOCCUS-PNEUMONIAE PROTEINS, FILIPINO PREGNANT-WOMEN, ANTIBODY-RESPONSE, CONJUGATE VACCINE, SURFACE ADHESIN, IMMUNIZATION, PROTECTION, CARRIAGE |
| الوصف: | Background: New vaccines containing highly conserved Streptococcus pneumoniae proteins such as pneumolysin toxoid (dPly) and histidine-triad protein D (PhtD) are being developed to provide broader protection against pneumococcal disease. This study evaluated the safety, reactogenicity and immunogenicity of different pneumococcal protein-containing formulations in adults. Methods: In a phase I double-blind study (www.clinicaltrials.gov: NC100707798), healthy adults (18-40 years) were randomized (1:2:2:2:2:2:2) to receive two doses of one of six investigational vaccine formulations 2 months apart, or a single dose of the control 23-valent pneumococcal polysaccharide vaccine (23PPV; Pneumovax23 (TM), Sanofi Pasteur MSD) followed by placebo. The investigational formulations contained dPly alone (10 or 30 mu g), or both dPly and PhtD (10 or 30 mu g each) alone or combined with the polysaccharide conjugates of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV; Synflorix (TM), GlaxoSmithKline Vaccines). Two groups primed with a formulation containing dPly and PhtD (10 or 30 mu g each) continued to the follow-up phase II study (NCT00896064), in which they received a booster dose at 5-9 months after primary vaccination. Results: Of 156 enrolled and vaccinated adults, 146 completed the primary immunization and 43 adults received a booster dose. During primary and booster vaccination, for any formulation, <= 8.9% of doses were followed by grade 3 solicited local or general adverse events. No fever >39.5 degrees C (oral temperature) was reported. Unsolicited adverse events considered causally related to vaccination were reported following <= 33.3% of investigational vaccine doses. No serious adverse events were reported for adults receiving investigational vaccine formulations. Formulations containing dPly with or without PhtD were immunogenic for these antigens; polysaccharide conjugate-containing formulations were also immunogenic for those 10 polysaccharides. ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| العلاقة: | https://biblio.ugent.be/publication/6830599Test; http://hdl.handle.net/1854/LU-6830599Test; http://dx.doi.org/10.1016/j.vaccine.2014.02.052Test; https://biblio.ugent.be/publication/6830599/file/6830607Test |
| DOI: | 10.1016/j.vaccine.2014.02.052 |
| الإتاحة: | https://doi.org/10.1016/j.vaccine.2014.02.052Test https://biblio.ugent.be/publication/6830599Test http://hdl.handle.net/1854/LU-6830599Test https://biblio.ugent.be/publication/6830599/file/6830607Test |
| حقوق: | No license (in copyright) ; info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.36905CA1 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/j.vaccine.2014.02.052 |
|---|