دورية أكاديمية
A phase IIA extension study evaluating the effect of booster vaccination with a fractional dose of RTS,S/AS01 E in a controlled human malaria infection challenge.
| العنوان: | A phase IIA extension study evaluating the effect of booster vaccination with a fractional dose of RTS,S/AS01 |
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| المؤلفون: | Moon JE; Walter Reed Army Institute of Research (WRAIR), 503 Robert Grant Avenue, Silver Spring, MD 20910, USA. Electronic address: james.e.moon.mil@mail.mil., Greenleaf ME; Walter Reed Army Institute of Research (WRAIR), 503 Robert Grant Avenue, Silver Spring, MD 20910, USA. Electronic address: Melissa.e.greenleaf.ctr@mail.mil., Regules JA; Walter Reed Army Institute of Research (WRAIR), 503 Robert Grant Avenue, Silver Spring, MD 20910, USA. Electronic address: jason.a.regules.mil@mail.mil., Debois M; GSK, 20 Avenue Fleming, 1300 Wavre, Belgium. Electronic address: muriel.l.debois@gsk.com., Duncan EH; Walter Reed Army Institute of Research (WRAIR), 503 Robert Grant Avenue, Silver Spring, MD 20910, USA. Electronic address: elizabeth.h.duncangooden.civ@mail.mil., Sedegah M; Naval Medical Research Center (NMRC), 503 Robert Grant Avenue, Silver Spring, MD 20910, USA. Electronic address: martha.sedegah.civ@mail.mil., Chuang I; Naval Medical Research Center (NMRC), 503 Robert Grant Avenue, Silver Spring, MD 20910, USA. Electronic address: Ilin.chuang.mil@mail.mil., Lee CK; PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98121, USA. Electronic address: clee@path.org., Sikaffy AK; Walter Reed Army Institute of Research (WRAIR), 503 Robert Grant Avenue, Silver Spring, MD 20910, USA. Electronic address: asikaffy@icongphs.com., Garver LS; Walter Reed Army Institute of Research (WRAIR), 503 Robert Grant Avenue, Silver Spring, MD 20910, USA. Electronic address: lindsey.s.garverbaldwin.civ@mail.mil., Ivinson K; PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98121, USA. Electronic address: kivinson@path.org., Angov E; Walter Reed Army Institute of Research (WRAIR), 503 Robert Grant Avenue, Silver Spring, MD 20910, USA. Electronic address: evelina.angov.civ@mail.mil., Morelle D; GSK, 20 Avenue Fleming, 1300 Wavre, Belgium. Electronic address: danielle.morelle@gsk.com., Lievens M; GSK, 20 Avenue Fleming, 1300 Wavre, Belgium. Electronic address: marc.lievens@gsk.com., Ockenhouse CF; PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98121, USA. Electronic address: cockenhouse@path.org., Ngauy V; Walter Reed Army Institute of Research (WRAIR), 503 Robert Grant Avenue, Silver Spring, MD 20910, USA. Electronic address: viseth.ngauy.mil@mail.mil., Ofori-Anyinam O; GSK, 20 Avenue Fleming, 1300 Wavre, Belgium. Electronic address: opokua.ofori-anyinam@gsk.com. |
| مؤلفون مشاركون: | RTS S Malaria Vaccine Working Group |
| المصدر: | Vaccine [Vaccine] 2021 Oct 15; Vol. 39 (43), pp. 6398-6406. Date of Electronic Publication: 2021 Sep 27. |
| نوع المنشور: | Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S. |
| 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: | Malaria* , Malaria Vaccines* , Malaria, Falciparum*/prevention & control, Antibodies, Protozoan ; Humans ; Plasmodium falciparum ; Vaccination |
| مستخلص: | Background: We previously demonstrated that RTS,S/AS01 Methods: 49 participants (P-Fx: 25; NP-Fx: 24) received a fractional (1/5th dose-volume) RTS,S/AS01 Results: Overall vaccine efficacy against re-challenge was 53% (95% CI: 37-65%), and similar for P-Fx (52% [95% CI: 28-68%]) and NP-Fx (54% [95% CI: 29-70%]). Efficacy appeared unaffected by primary regimen or previous protection status. Anti-CS (repeat region) antibody geometric mean concentrations (GMCs) increased post-booster vaccination. GMCs were maintained over time in primary three-dose groups but declined in the two-dose group. Protection after re-challenge was associated with higher anti-CS antibody responses. The booster was well-tolerated. Conclusions: A fractional RTS,S/AS01 Clinical Trial Registration: NCT03824236. linked to this article can be found on the Research Data as well as Figshare https://figshare.com/s/ee025150f9d1ac739361. Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Lievens, Marc; Morelle, Danielle; Debois, Muriel and Ofori-Anyinam, Opokua; are employees of the GSK group of companies. Debois, Muriel; Morelle, Danielle; Lievens, Marc; Ofori-Anyinam, Opokua have restricted shares in the GSK group of companies. Greenleaf, Melissa; Duncan, Elizabeth; Chuang, Ilin; Angov, Evelina; Ivinson, Karen; Komisar, Jack; Lee, Cynthia; Moon, James; Ockenhouse, Christian; Regules, Jason; Garver, Lindsey; Sedegah, Martha; Sikaffy, April K; Ngauy, Viseth declare no competing interests. (Copyright © 2021 GlaxoSmithKline Biologicals S.A. Published by Elsevier Ltd.. All rights reserved.) |
| فهرسة مساهمة: | Keywords: Booster; Controlled human malaria infection re-challenge; Efficacy; Fractional dose; Plasmodium falciparum malaria; RTS; S/AS01 |
| سلسلة جزيئية: | ClinicalTrials.gov NCT03824236 |
| المشرفين على المادة: | 0 (Antibodies, Protozoan) 0 (Malaria Vaccines) |
| تواريخ الأحداث: | Date Created: 20211001 Date Completed: 20211025 Latest Revision: 20211025 |
| رمز التحديث: | 20240628 |
| DOI: | 10.1016/j.vaccine.2021.09.024 |
| PMID: | 34593270 |
| قاعدة البيانات: | MEDLINE |
Full Text via ClinicalKey 
Full Text Finder | تدمد: | 1873-2518 |
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| DOI: | 10.1016/j.vaccine.2021.09.024 |