دورية أكاديمية
A First for Human Vaccinology: GMP Compliant Radiation Attenuation of Plasmodium falciparum Sporozoites for Production of a Vaccine Against Malaria.
| العنوان: | A First for Human Vaccinology: GMP Compliant Radiation Attenuation of Plasmodium falciparum Sporozoites for Production of a Vaccine Against Malaria. |
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| المؤلفون: | James ER; Sanaria Inc., Rockville, MD, United States., Matheny S; Sanaria Inc., Rockville, MD, United States., Overby J; Sanaria Inc., Rockville, MD, United States., Sim BKL; Sanaria Inc., Rockville, MD, United States., Eappen AG; Sanaria Inc., Rockville, MD, United States., Li T; Sanaria Inc., Rockville, MD, United States., Li ML; Sanaria Inc., Rockville, MD, United States., Richie TL; Sanaria Inc., Rockville, MD, United States., Chakravarty S; Sanaria Inc., Rockville, MD, United States., Gunasekera A; Sanaria Inc., Rockville, MD, United States., Murshedkar T; Sanaria Inc., Rockville, MD, United States., Billingsley PF; Sanaria Inc., Rockville, MD, United States., Hoffman SL; Sanaria Inc., Rockville, MD, United States. |
| المصدر: | Frontiers in immunology [Front Immunol] 2022 Feb 15; Vol. 13, pp. 851028. Date of Electronic Publication: 2022 Feb 15 (Print Publication: 2022). |
| نوع المنشور: | Journal Article; Research Support, N.I.H., Extramural |
| اللغة: | English |
| بيانات الدورية: | Publisher: Frontiers Research Foundation] Country of Publication: Switzerland NLM ID: 101560960 Publication Model: eCollection Cited Medium: Internet ISSN: 1664-3224 (Electronic) Linking ISSN: 16643224 NLM ISO Abbreviation: Front Immunol Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: [Lausanne : Frontiers Research Foundation] |
| مواضيع طبية MeSH: | Culicidae* , Malaria* , Malaria Vaccines* , Malaria, Falciparum*/prevention & control, Animals ; Humans ; Plasmodium falciparum ; Sporozoites ; Vaccines, Attenuated ; Vaccinology |
| مستخلص: | Ionizing radiation (UV, X-ray and ɣ) administered at an appropriate dose to pathogenic organisms can prevent replication while preserving metabolic activity. We have established the GMP process for attenuation by ionizing radiation of the Plasmodium falciparum (Pf) sporozoites (SPZ) in Sanaria ® PfSPZ Vaccine, a protective vaccine against malaria. Mosquitoes raised and infected aseptically with Pf were transferred into infected mosquito transport containers (IMTC) and ɣ-irradiated using a 60 Co source. PfSPZ were then extracted, purified, vialed, and cryopreserved. To establish the appropriate radiation conditions, the irradiation field inside the IMTCs was mapped using radiochromic film and alanine transfer dosimeters. Dosimeters were irradiated for times calculated to provide 120-170 Gy at the minimum dose location inside the IMTC and regression analysis was used to determine the time required to achieve a lower 95% confidence interval for 150 Gy. A formula incorporating the half-life of 60 Co was then used to construct tables of irradiation times for each calendar day. From the mapping studies, formulae were derived to estimate the minimum and maximum doses of irradiation received inside the IMTC from a reference dosimeter mounted on the outside wall. For PfSPZ Vaccine manufacture a dose of 150 Gy was targeted for each irradiation event, a dose known to completely attenuate PfSPZ. The reference dosimeters were processed by the National Institute of Standards and Technology. There have been 587 irradiation events to produce PfSPZ Vaccine during 13 years which generated multiple lots released for pre-clinical studies and clinical trials. The estimated doses at the minimum dose location (mean 154.3 ± 1.77 Gy; range 150.0-159.3 Gy), and maximum dose location (mean 166.3 ± 3.65 Gy, range 155.7 to 175.3 Gy), in IMTCs were normally distributed. Overall dose uniformity was 1.078 ± 0.012. There was no siginifcant change in measured dose over 13 years. As of January 2022, 21 clinical trials of PfSPZ Vaccine have been conducted, with 1,740 volunteers aged 5 months to 61 years receiving 5,648 doses of PfSPZ Vaccine totalling >5.3 billion PfSPZ administered. There have been no breakthrough infections, confirming the consistency and robustness of the radiation attenuation process. Competing Interests: All authors are employed by Sanaria Inc. (Copyright © 2022 James, Matheny, Overby, Sim, Eappen, Li, Li, Richie, Chakravarty, Gunasekera, Murshedkar, Billingsley and Hoffman.) |
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| فهرسة مساهمة: | Keywords: attenuation; malaria; radiation; sporozoite; vaccine |
| المشرفين على المادة: | 0 (Malaria Vaccines) 0 (Vaccines, Attenuated) |
| تواريخ الأحداث: | Date Created: 20220304 Date Completed: 20220503 Latest Revision: 20220503 |
| رمز التحديث: | 20240628 |
| مُعرف محوري في PubMed: | PMC8886114 |
| DOI: | 10.3389/fimmu.2022.851028 |
| PMID: | 35242146 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1664-3224 |
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| DOI: | 10.3389/fimmu.2022.851028 |