A Phase IIa Controlled Human Malaria Infection and Immunogenicity Study of RTS,S/AS01E and RTS,S/AS01B Delayed Fractional Dose Regimens in Malaria-Naive Adults.

التفاصيل البيبلوغرافية
العنوان:	A Phase IIa Controlled Human Malaria Infection and Immunogenicity Study of RTS,S/AS01E and RTS,S/AS01B Delayed Fractional Dose Regimens in Malaria-Naive Adults.
المؤلفون:	Moon JE; Walter Reed Army Institute of Research, Silver Spring, Maryland, USA., Ockenhouse C; PATH-Malaria Vaccine Initiative, Washington, DC, USA., Regules JA; Walter Reed Army Institute of Research, Silver Spring, Maryland, USA., Vekemans J; GSK Biologicals, Rixensart, Belgium., Lee C; PATH-Malaria Vaccine Initiative, Washington, DC, USA., Chuang I; Naval Medical Research Center, Silver Spring, Maryland, USA., Traskine M; GSK Biologicals, Rixensart, Belgium., Jongert E; GSK Biologicals, Rixensart, Belgium., Ivinson K; PATH-Malaria Vaccine Initiative, Washington, DC, USA., Morelle D; GSK Biologicals, Rixensart, Belgium., Komisar JL; Naval Medical Research Center, Silver Spring, Maryland, USA., Lievens M; GSK Biologicals, Rixensart, Belgium., Sedegah M; Naval Medical Research Center, Silver Spring, Maryland, USA., Garver LS; Walter Reed Army Institute of Research, Silver Spring, Maryland, USA., Sikaffy AK; Walter Reed Army Institute of Research, Silver Spring, Maryland, USA., Waters NC; Walter Reed Army Institute of Research, Silver Spring, Maryland, USA., Ballou WR; GSK Biologicals, Rixensart, Belgium., Ofori-Anyinam O; GSK Biologicals, Rixensart, Belgium.
مؤلفون مشاركون:	RTS,S Malaria Vaccine Working Group
المصدر:	The Journal of infectious diseases [J Infect Dis] 2020 Oct 13; Vol. 222 (10), pp. 1681-1691.
نوع المنشور:	Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.
اللغة:	English
بيانات الدورية:	Publisher: Oxford University Press Country of Publication: United States NLM ID: 0413675 Publication Model: Print Cited Medium: Internet ISSN: 1537-6613 (Electronic) Linking ISSN: 00221899 NLM ISO Abbreviation: J Infect Dis Subsets: MEDLINE
أسماء مطبوعة:	Publication: Jan. 2011- : Oxford : Oxford University Press Original Publication: 1904-2010 : Chicago, IL : University of Chicago Press
مواضيع طبية MeSH:	Malaria/immunology , Malaria/prevention & control , Malaria Vaccines/administration & dosage , Malaria Vaccines/immunology, Adolescent ; Adult ; Female ; Humans ; Immunization Schedule ; Infection Control ; Malaria, Falciparum/immunology ; Malaria, Falciparum/prevention & control ; Male ; Middle Aged ; Plasmodium falciparum/immunology ; Vaccination ; Young Adult
مستخلص:	Background: A previous RTS,S/AS01B vaccine challenge trial demonstrated that a 3-dose (0-1-7-month) regimen with a fractional third dose can produce high vaccine efficacy (VE) in adults challenged 3 weeks after vaccination. This study explored the VE of different delayed fractional dose regimens of adult and pediatric RTS,S/AS01 formulations. Methods: A total of 130 participants were randomized into 5 groups. Four groups received 3 doses of RTS,S/AS01B or RTS,S/AS01E on a 0-1-7-month schedule, with the final 1 or 2 doses being fractional (one-fifth dose volume). One group received 1 full (month 0) and 1 fractional (month 7) dose of RTS,S/AS01E. Immunized and unvaccinated control participants underwent Plasmodium falciparum-infected mosquito challenge (controlled human malaria infection) 3 months after immunization, a timing chosen to potentially discriminate VEs between groups. Results: The VE of 3-dose formulations ranged from 55% (95% confidence interval, 27%-72%) to 76% (48%-89%). Groups administered equivalent formulations of RTS,S/AS01E and RTS,S/AS01B demonstrated comparable VE. The 2-dose group demonstrated lower VE (29% [95% confidence interval, 6%-46%]). All regimens were well tolerated and immunogenic, with trends toward higher anti-circumsporozoite antibody titers in participants protected against infection. Conclusions: RTS,S/AS01E can provide VE comparable to an equivalent RTS,S/AS01B regimen in adults, suggesting a universal formulation may be considered. Results also suggest that the 2-dose regimen is inferior to the 3-dose regimens evaluated. Clinical Trial Registration: NCT03162614. (© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America.)
التعليقات:	Comment in: J Infect Dis. 2020 Oct 13;222(10):1581-1584. (PMID: 32685977)
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فهرسة مساهمة:	Investigator: SB Cicatelli; EH Duncan; KT Mills; CE Lee; JE Epstein; JJ Cowden; MD Spring; MJ Hamer; NK Copeland; V Ngauy; DM Tosh; JM Curley; JW Bennett; M Riddle; PE Waterman; MA Koren; JN Hutter; E Bergmann-Leitner; J Kooken; E Angov; K Peterson; A Leprince; L Murray Keywords: Plasmodium falciparum; 3-month challenge; RTS; S/AS01; controlled human malaria infection; delayed fractional dose; efficacy; immunogenicity; malaria; safety
سلسلة جزيئية:	ClinicalTrials.gov NCT03162614
المشرفين على المادة:	0 (Malaria Vaccines)
تواريخ الأحداث:	Date Created: 20200721 Date Completed: 20210311 Latest Revision: 20210311
رمز التحديث:	20221213
مُعرف محوري في PubMed:	PMC7552430
DOI:	10.1093/infdis/jiaa421
PMID:	32687161
قاعدة البيانات:	MEDLINE

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تدمد:	1537-6613
DOI:	10.1093/infdis/jiaa421