دورية أكاديمية
Protection against Plasmodium falciparum malaria by PfSPZ Vaccine.
| العنوان: | Protection against Plasmodium falciparum malaria by PfSPZ Vaccine. |
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| المؤلفون: | Epstein JE; Naval Medical Research Center (NMRC)., Paolino KM; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA., Richie TL; Sanaria Inc., Rockville, Maryland, USA., Sedegah M; Naval Medical Research Center (NMRC)., Singer A; Naval Medical Research Center (NMRC)., Ruben AJ; Sanaria Inc., Rockville, Maryland, USA., Chakravarty S; Sanaria Inc., Rockville, Maryland, USA., Stafford A; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA., Ruck RC; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA., Eappen AG; Sanaria Inc., Rockville, Maryland, USA., Li T; Sanaria Inc., Rockville, Maryland, USA., Billingsley PF; Sanaria Inc., Rockville, Maryland, USA., Manoj A; Sanaria Inc., Rockville, Maryland, USA., Silva JC; Institute for Genome Sciences, University of Maryland School of Medicine, Baltimore, Maryland, USA., Moser K; Institute for Genome Sciences, University of Maryland School of Medicine, Baltimore, Maryland, USA., Nielsen R; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA., Tosh D; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA., Cicatelli S; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA., Ganeshan H; Naval Medical Research Center (NMRC)., Case J; Statistics Collaborative Inc., Washington, DC, USA., Padilla D; Sanaria Inc., Rockville, Maryland, USA., Davidson S; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA., Garver L; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA., Saverino E; Sanaria Inc., Rockville, Maryland, USA., Murshedkar T; Sanaria Inc., Rockville, Maryland, USA., Gunasekera A; Sanaria Inc., Rockville, Maryland, USA., Twomey PS; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA., Reyes S; Naval Medical Research Center (NMRC)., Moon JE; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA., James ER; Sanaria Inc., Rockville, Maryland, USA., Kc N; Sanaria Inc., Rockville, Maryland, USA.; Protein Potential, Rockville, Maryland, USA., Li M; Sanaria Inc., Rockville, Maryland, USA.; Protein Potential, Rockville, Maryland, USA., Abot E; Naval Medical Research Center (NMRC)., Belmonte A; Naval Medical Research Center (NMRC)., Hauns K; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA., Belmonte M; Naval Medical Research Center (NMRC)., Huang J; Naval Medical Research Center (NMRC)., Vasquez C; Naval Medical Research Center (NMRC)., Remich S; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA., Carrington M; Naval Medical Research Center (NMRC)., Abebe Y; Sanaria Inc., Rockville, Maryland, USA., Tillman A; Statistics Collaborative Inc., Washington, DC, USA., Hickey B; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA., Regules J; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA., Villasante E; Naval Medical Research Center (NMRC)., Sim BKL; Sanaria Inc., Rockville, Maryland, USA.; Protein Potential, Rockville, Maryland, USA., Hoffman SL; Sanaria Inc., Rockville, Maryland, USA. |
| المصدر: | JCI insight [JCI Insight] 2017 Jan 12; Vol. 2 (1), pp. e89154. Date of Electronic Publication: 2017 Jan 12. |
| نوع المنشور: | Clinical Trial; Comparative Study; Journal Article; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, Non-P.H.S. |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Society for Clinical Investigation Country of Publication: United States NLM ID: 101676073 Publication Model: Electronic Cited Medium: Print ISSN: 2379-3708 (Print) Linking ISSN: 23793708 NLM ISO Abbreviation: JCI Insight Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Ann Arbor, Michigan : American Society for Clinical Investigation, [2016]- |
| مواضيع طبية MeSH: | Malaria, Falciparum/*therapy , Plasmodium falciparum/*drug effects , Sporozoites/*drug effects , Vaccines, Attenuated/*administration & dosage, Administration, Intravenous ; Adult ; Female ; Humans ; Malaria, Falciparum/prevention & control ; Male ; Plasmodium falciparum/genetics ; Sporozoites/genetics ; T-Lymphocytes/immunology ; Vaccines, Attenuated/therapeutic use ; Whole Genome Sequencing/methods |
| مستخلص: | BACKGROUND : A radiation-attenuated Plasmodium falciparum (Pf) sporozoite (SPZ) malaria vaccine, PfSPZ Vaccine, protected 6 of 6 subjects (100%) against homologous Pf (same strain as in the vaccine) controlled human malaria infection (CHMI) 3 weeks after 5 doses administered intravenously. The next step was to assess protective efficacy against heterologous Pf (different from Pf in the vaccine), after fewer doses, and at 24 weeks. METHODS : The trial assessed tolerability, safety, immunogenicity, and protective efficacy of direct venous inoculation (DVI) of 3 or 5 doses of PfSPZ Vaccine in non-immune subjects. RESULTS : Three weeks after final immunization, 5 doses of 2.7 × 10 5 PfSPZ protected 12 of 13 recipients (92.3% [95% CI: 48.0, 99.8]) against homologous CHMI and 4 of 5 (80.0% [10.4, 99.5]) against heterologous CHMI; 3 doses of 4.5 × 10 5 PfSPZ protected 13 of 15 (86.7% [35.9, 98.3]) against homologous CHMI. Twenty-four weeks after final immunization, the 5-dose regimen protected 7 of 10 (70.0% [17.3, 93.3]) against homologous and 1 of 10 (10.0% [-35.8, 45.6]) against heterologous CHMI; the 3-dose regimen protected 8 of 14 (57.1% [21.5, 76.6]) against homologous CHMI. All 22 controls developed Pf parasitemia. PfSPZ Vaccine was well tolerated, safe, and easy to administer. No antibody or T cell responses correlated with protection. CONCLUSIONS : We have demonstrated for the first time to our knowledge that PfSPZ Vaccine can protect against a 3-week heterologous CHMI in a limited group of malaria-naive adult subjects. A 3-dose regimen protected against both 3-week and 24-week homologous CHMI (87% and 57%, respectively) in this population. These results provide a foundation for developing an optimized immunization regimen for preventing malaria. TRIAL REGISTRATION : ClinicalTrials.gov NCT02215707. FUNDING : Support was provided through the US Army Medical Research and Development Command, Military Infectious Diseases Research Program, and the Naval Medical Research Center's Advanced Medical Development Program. Competing Interests: T.L. Richie, A.J. Ruben, S. Chakravarty, A.G. Eappen, T. Li, P.F. Billingsley, A. Manoj, D. Padilla, E. Saverino, T. Murshedkar, A. Gunasekera, E.R. James, N. KC, M. Li, Y. Abebe, B.K.L. Sim, and S.L. Hoffman are salaried employees of Sanaria Inc., the developer and owner of PfSPZ Vaccine and the sponsor of the clinical trial. In addition, S.L. Hoffman and B.K.L. Sim have a financial interest in Sanaria Inc. |
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| معلومات مُعتمدة: | U19 AI110820 United States AI NIAID NIH HHS |
| سلسلة جزيئية: | ClinicalTrials.gov NCT02215707 |
| المشرفين على المادة: | 0 (Vaccines, Attenuated) |
| تواريخ الأحداث: | Date Created: 20170119 Date Completed: 20190613 Latest Revision: 20190613 |
| رمز التحديث: | 20240628 |
| مُعرف محوري في PubMed: | PMC5214067 |
| DOI: | 10.1172/jci.insight.89154 |
| PMID: | 28097230 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 2379-3708 |
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| DOI: | 10.1172/jci.insight.89154 |