دورية أكاديمية
أعرض في EDS

Increase of Dose Associated With Decrease in Protection Against Controlled Human Malaria Infection by PfSPZ Vaccine in Tanzanian Adults.

التفاصيل البيبلوغرافية
العنوان: Increase of Dose Associated With Decrease in Protection Against Controlled Human Malaria Infection by PfSPZ Vaccine in Tanzanian Adults.
المؤلفون: Jongo SA; Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania., Church LWP; Sanaria Inc., Rockville, Maryland, USA., Mtoro AT; Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania., Schindler T; Swiss Tropical and Public Health Institute, Basel, Switzerland.; University of Basel, Switzerland., Chakravarty S; Sanaria Inc., Rockville, Maryland, USA., Ruben AJ; Sanaria Inc., Rockville, Maryland, USA., Swanson PA; Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA., Kassim KR; Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania., Mpina M; Swiss Tropical and Public Health Institute, Basel, Switzerland.; University of Basel, Switzerland., Tumbo AM; Swiss Tropical and Public Health Institute, Basel, Switzerland.; University of Basel, Switzerland., Milando FA; Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania., Qassim M; Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania., Juma OA; Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania., Bakari BM; Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania., Simon B; Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania., James ER; Sanaria Inc., Rockville, Maryland, USA., Abebe Y; Sanaria Inc., Rockville, Maryland, USA., Kc N; Sanaria Inc., Rockville, Maryland, USA., Saverino E; Sanaria Inc., Rockville, Maryland, USA., Fink M; Swiss Tropical and Public Health Institute, Basel, Switzerland.; University of Basel, Switzerland., Cosi G; Swiss Tropical and Public Health Institute, Basel, Switzerland.; University of Basel, Switzerland., Gondwe L; Swiss Tropical and Public Health Institute, Basel, Switzerland.; University of Basel, Switzerland., Studer F; Swiss Tropical and Public Health Institute, Basel, Switzerland.; University of Basel, Switzerland., Styers D; The Emmes Corporation, Rockville, Maryland, USA., Seder RA; Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA., Schindler T; Swiss Tropical and Public Health Institute, Basel, Switzerland.; University of Basel, Switzerland., Billingsley PF; Sanaria Inc., Rockville, Maryland, USA., Daubenberger C; Swiss Tropical and Public Health Institute, Basel, Switzerland.; University of Basel, Switzerland., Sim BKL; Sanaria Inc., Rockville, Maryland, USA.; Protein Potential LLC, Rockville, Maryland, USA., Tanner M; Swiss Tropical and Public Health Institute, Basel, Switzerland.; University of Basel, Switzerland., Richie TL; Sanaria Inc., Rockville, Maryland, USA., Abdulla S; Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania., Hoffman SL; Sanaria Inc., Rockville, Maryland, USA.
المصدر: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2020 Dec 31; Vol. 71 (11), pp. 2849-2857.
نوع المنشور: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Oxford University Press Country of Publication: United States NLM ID: 9203213 Publication Model: Print Cited Medium: Internet ISSN: 1537-6591 (Electronic) Linking ISSN: 10584838 NLM ISO Abbreviation: Clin Infect Dis Subsets: MEDLINE
أسماء مطبوعة: Publication: Jan. 2011- : Oxford : Oxford University Press
Original Publication: Chicago, IL : The University of Chicago Press, c1992-
مواضيع طبية MeSH: Malaria*/prevention & control , Malaria Vaccines* , Malaria, Falciparum*/prevention & control, Adult ; Animals ; Europe ; Humans ; Mali ; Plasmodium falciparum ; Sporozoites ; Tanzania
مستخلص: Background: A vaccine would be an ideal tool for reducing malaria's impact. PfSPZ Vaccine (radiation attenuated, aseptic, purified, cryopreserved Plasmodium falciparum [Pf] sporozoites [SPZ]) has been well tolerated and safe in >1526 malaria-naive and experienced 6-month to 65-year-olds in the United States, Europe, and Africa. When vaccine efficacy (VE) of 5 doses of 2.7 × 105 PfSPZ of PfSPZ Vaccine was assessed in adults against controlled human malaria infection (CHMI) in the United States and Tanzania and intense field transmission of heterogeneous Pf in Mali, Tanzanians had the lowest VE (20%).
Methods: To increase VE in Tanzania, we increased PfSPZ/dose (9 × 105 or 1.8 × 106) and decreased numbers of doses to 3 at 8-week intervals in a double blind, placebo-controlled trial.
Results: All 22 CHMIs in controls resulted in parasitemia by quantitative polymerase chain reaction. For the 9 × 105 PfSPZ group, VE was 100% (5/5) at 3 or 11 weeks (P < .000l, Barnard test, 2-tailed). For 1.8 × 106 PfSPZ, VE was 33% (2/6) at 7.5 weeks (P = .028). VE of dosage groups (100% vs 33%) was significantly different (P = .022). Volunteers underwent repeat CHMI at 37-40 weeks after last dose. 6/6 and 5/6 volunteers developed parasitemia, but time to first parasitemia was significantly longer than controls in the 9 × 105 PfSPZ group (10.89 vs 7.80 days) (P = .039), indicating a significant reduction in parasites in the liver. Antibody and T-cell responses were higher in the 1.8 × 106 PfSPZ group.
Conclusions: In Tanzania, increasing the dose from 2.7 × 105 to 9 × 105 PfSPZ increased VE from 20% to 100%, but increasing to 1.8 × 106 PfSPZ significantly reduced VE.
Clinical Trials Registration: NCT02613520.
(© The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)
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فهرسة مساهمة: Keywords: Plasmodium falciparum; PfSPZ; controlled human malaria infection; malaria; vaccine efficacy
سلسلة جزيئية: ClinicalTrials.gov NCT02613520
المشرفين على المادة: 0 (Malaria Vaccines)
تواريخ الأحداث: Date Created: 20191130 Date Completed: 20210428 Latest Revision: 20210428
رمز التحديث: 20221213
مُعرف محوري في PubMed: PMC7947995
DOI: 10.1093/cid/ciz1152
PMID: 31782768
قاعدة البيانات: MEDLINE
الوصف
تدمد:1537-6591
DOI:10.1093/cid/ciz1152