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Translation - English Rationale: This is a study to assess the immunogenicity, efficacy and safety of S268019b, a candidate vaccine for the prevention of coronavirus disease 2019 (COVID-19) as compared to a licensed COVID-19 vaccine (the ChAdOx1 nCoV-19 vaccine). COVID-19 is causing the tightness of the healthcare system in various countries in the world. Several COVID-19 vaccines have become available; however, the vaccine supply has been still limited from a global perspective. Thus, rapid development of new COVID-19 vaccines is awaited. The proposed study is conducted to determine if the immunogenicity of S268019b as measured by the geometric mean titer (GMT) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing antibody (NAb) is superior to that of the ChAdOx1 nCoV-19 vaccine or not.
Japanese to English: Clinical Trial Agreement General field: Medical Detailed field: Law: Contract(s)
Source text - Japanese 本治験の実施）
第２条 甲及び乙は、医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律（以下「医薬品医療機器等法」という。）、同施行令、同施行規則、ＧＣＰ省令及びＧＣＰ省令に関連する通知（以下これらを総称して「ＧＣＰ省令等」という。）およびヘルシンキ宣言を遵守して、本治験を実施するものとする。
Translation - English (Implementation of Clinical Trial)
Article 2. Party A and Party B shall conduct the Clinical Trial in compliance with the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (hereinafter referred to as “Pharmaceuticals and Medical Devices Act”), the Enforcement Order of the same act, the Enforcement Regulations of the same act, the GCP Ordinance, and notices related to the GCP Ordinance (hereinafter collectively referred to as “GCP Ordinance, etc.”), and the Declaration of Helsinki.
Japanese to English: Science Japan article abstract General field: Medical Detailed field: Biology (-tech,-chem,micro-)
Translation - English [Appendix 2] English translation and native checking of Japanese language science and technology articles for Science Japan.
(July, 2021 - March, 2022) Japanese sample text 2
[Title]
“Elimination of senescent cells” with a Glutaminase-1 (GLS1) inhibitor demonstrated effective in mice for amelioration of aging and lifestyle-associated diseases.
[Body text]
A research group at the Institute of Medical Science, Tokyo University, published findings that the glutamine metabolizing enzyme “GLS1” (Glutaminase-1) is essential for the survival of senescent cells, and that that age-associated conditions showed improvement in mice with the elimination of senescent cells through administration of inhibitors of this enzyme. It was demonstrated that the administration of GLS1 inhibitors in older mice and age-related disease model mice improved age-associated muscle weakness, arteriosclerosis, and kidney damage. This is expected to lead to the development of a wide range of drugs to treat diseases which increase in incidence with age.
Most diseases, except for infectious diseases, have age as a risk factor, such as arteriosclerosis, hypertension, dementia, and cancer. Chronic inflammation of organ tissue has been identified out as a common cause. Senescent cells accumulate in the body with aging, and are noninflammatory cells that are not necessarily required for ontogenetic survival, but are known to trigger inflammation. It was also found that the genetic elimination of senescent cells from older mice would inhibit the development of age-associated diseases such as arteriosclerosis and renal impairment. On the other hand, senescent cells are diverse, and it was unclear which drugs can eliminate them and their targets.
Up to now, the research group has confirmed the accumulation of senescent cells in almost all organs as they age.
Therefore, the research group has explored the genes essential for the survival of senescent cells, with the aim of developing drugs that induce cell death in senescent cells only. Specifically, the Lentiviral shRNA Library was infected with senescent cells, and compared on the 2nd and 16th days of infection.
As a result, it was found that the gene essential for survival of senescent cells is “GLS1”, which is an essential enzyme for glutamine metabolism. GLS1 expression induced specifically in senescent cells. "GLS1" is an enzyme that converts glutamine into glutamic acid to produce glutathione, and ammonia is produced as a by-product of this process by deamination acids. Since there are multiple pathways, it was found that partial inhibition does not affect glutamate production, but that ammonia production is significantly inhibited.
Examination of senescent cells also revealed that membranes of lysosomes, which are proteolytic organelles, were damaged compared to normal cells. In normal cells, this damage induced cell death due to lowered pH, while senescent cells were found to neutralize this and survive due to the ammonia produced. It was also found that damage to lysosomes can lead to inflammatory cells even if the cells are not senescent.
Therefore, when the "GLS1" inhibitor was administered to normal cells and senescent cells, only the production of ammonia was suppressed, and cell death could be selectively induced in just the senescent cells.
In fact, when an inhibitor was administered to a 2-year-old mouse (approximately 60 years old in human age), the rate of renal sclerosis, serum creatinine levels, and uric acid levels improved, with age-associated renal dysfunction significantly improved. Pulmonary fibrogenesis and inflammatory cell infiltration of the liver were also improved.
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Translation education
Bachelor's degree - Bristol U.W.E.
Experience
Years of experience: 21. Registered at ProZ.com: Jan 2003. Became a member: Aug 2005.
Credentials
Japanese to English (Japan Association of Translators)
I have been professionally translating Japanese since 2003, initially within my role as “Specialist Prefectural Advisor” to the Kyoto Prefectural Board of Education, Japan - then extending my expertise over the years within the technical, medical and legal fields.
My end-clients include leading Japanese manufacturers, global pharmaceutical companies and government agencies.
Recent clients and project history
Technical
Japan Radio Co. Emergency Warning Broadcast System (EWBS) Technical Manuals. (100k chars)
Nikon Corporation, Camera image processing software documentation (80k chars)
Toshiba Corporation, Quality control process documentation for semi-conductor manufacturing
Wacker Chemie AG - Surface treatment particle patent
IQVIA, Clinical Trial Research Protocols, Patient Information and Informed Consent Forms, Clinical Trial Agreements etc. (500k chars)
Pfizer Japan Inc. Selara Tablets, (Drug Information Sheet [Kusuri-no-Shiori]), VIAGRA OD Film (Materials relating to standards and test methods), Sulperazon for intravenous injection - Dosage calculation sheet
Member since Aug '05
Expertise 