呼吸道病毒疫苗比较免疫原性（CIRV2）研究 (CIRV2)
IDCRP-154：呼吸道病毒疫苗比较免疫原性（CIRV2）研究
CIRV2是一项IV期随机、开放标签的临床试验，针对美国食品药品监督管理局（FDA）批准的COVID-19和/或流感疫苗（风险不高于最小风险），并进行纵向随访。
2025年，CIRV2将比较重组Novavax COVID-19疫苗与mRNA辉瑞-BioNTech COVID-19疫苗的免疫原性和反应原性。
研究概览
地位
主动，不招人
详细说明
比较呼吸道病毒疫苗免疫原性（CIRV2）研究的目标是每年对FDA批准的最新版COVID-19和/或流感疫苗的免疫原性和反应原性进行直接比较。
研究将在符合FDA疫苗接种资格且没有严重损害免疫系统疾病的个体中进行。
对于2025年，该研究将直接比较2025年诺瓦瓦克斯重组COVID-19疫苗与2025年辉瑞/BioNTech mRNA COVID-19疫苗的免疫原性和反应原性。
研究类型
介入性
注册 (估计的)
54
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Maryland
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Bethesda、Maryland、美国、20814
- Walter Reed National Military Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
纳入标准
- 18-79岁
有以下任何一种严重COVID风险因素史：
- 哮喘
- 缺乏身体活动（定义为每周中等强度活动<150分钟或每周高强度活动<75分钟）
- HIV且CD4计数≥500细胞/ul
- 当前或既往吸烟者
- 抑郁症或其他情绪障碍
- 精神分裂症谱系障碍
- 脑血管疾病
- 心力衰竭
- 冠状动脉疾病
- 心肌病
- 肺栓塞
- 肺动脉高压
- 囊性纤维化
- 支气管扩张
- 慢性阻塞性肺疾病
- 间质性肺疾病
- I期或II期慢性肾脏病
- I期定义为肾小球滤过率正常（>90）但伴有其他肾脏损伤迹象，如蛋白尿或血尿
- II期定义为肾小球滤过率（GFR）为60-89 ml/min/1.73m²
- 妊娠期糖尿病
- 1型糖尿病且最近一次HgbA1C<7.5%
- 2型糖尿病且最近一次HgbA1C<7.5%
- 肥胖且BMI≥30且<40
- 无肝硬化的肝脏疾病且肝酶水平
- （AST和ALT）不超过正常值上限的三倍
- 军事卫生系统受益者且符合DEERS资格
- 愿意随机接受诺瓦瓦克斯COVID-19疫苗或mRNA辉瑞- BioNTech COVID-19疫苗
- 能够在大约30天后返回诊所进行随访，并能在接下来的9个月内在线完成随访。
排除标准
- 对mRNA COVID-19疫苗或诺瓦瓦克斯重组COVID-19疫苗的任何成分有严重过敏或严重不良反应史，如心肌炎
- 在过去3个月内接种过COVID-19疫苗。
在过去3个月内COVID-19检测呈阳性。
- 在筛选/入组访视当天出现发热、咳嗽、寒战、呼吸急促、流鼻涕或喉咙痛。
正在使用免疫调节药物。
- 定义为正在长期使用免疫调节药物，如全身性皮质类固醇，剂量相当于每天泼尼松20毫克或以上，持续超过一个月，或使用化疗药物、细胞因子抑制剂、或减少T细胞或B细胞数量或功能的药物。
诊断为免疫功能低下状态。
- 定义为：存在导致严重免疫抑制的疾病，或有脾切除史（脾脏切除）。
- 糖尿病且最近一次HgbA1C≥7.5。
III期或更严重的慢性肾脏病
- 定义为估计肾小球滤过率<60 ml/min/1.73m²）
- 肥胖且BMI≥40
- HIV且CD4细胞计数<500细胞/ul
- 有实体器官或骨髓移植史。
活动性恶性肿瘤
- 定义为任何正在接受治疗或在过去一年内有进展证据的癌症。
- 慢性肝病伴有代偿性或失代偿性肝硬化，或肝酶水平（AST或ALT）超过正常值上限的三倍。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：For fall of 2026, Arm 1 of the study will be the Pfizer-BioNTech mRNA COVID-19 vac
Arm 1 of the study will be Pfizer-BioNTech mRNA COVID-19 vaccine
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COVID-19 疫苗，mRNA
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有源比较器：For fall of 2026, Arm 2 of the study will be the Novavax recombinant protein vaccine
Arm 2 of the study will be the Novavax recombinant protein vaccine
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重组蛋白疫苗
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Variant-specific immune responses
大体时间：IgG binding antibody levels and neutralizing antibody titers will be assessed on serum samples obtained just prior to vaccination, 30 days (+/- 10 days), and 150 days (+/- 10 days) after vaccination.
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The primary endpoint is variant-specific immune response (magnitude and breadth) to licensed recombinant and mRNA COVID-19 products administered to adult MHS beneficiaries who are eligible for a fall COVID-19 vaccine and who are not severely immunocompromised.
This will include quantifying the magnitude of binding and neutralizing antibodies to the vaccine variants and to the dominant variant present 30 days and 150 days post-vaccination.
Specifically, we will test neutralizing titers (defined as the inverse serum dilution causing a 50% reduction in relative light units in a pseudovirus neutralization assay) and IgG binding antibody levels (measured in arbitrary units) against the following SARS-CoV-2 variants: XFG (vaccine strain), Wuhan-1 (ancestral strain), plus the dominant circulating variant(s) circulating during the fall of 2026 and winter of 2026-2027.
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IgG binding antibody levels and neutralizing antibody titers will be assessed on serum samples obtained just prior to vaccination, 30 days (+/- 10 days), and 150 days (+/- 10 days) after vaccination.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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疫苗反应原性及其他偶发性不良事件（两种已获许可的COVID-19平台——重组蛋白与mRNA技术之间的比较）
大体时间：疫苗接种后的9个月内将评估反应原性及其他偶发不良事件。
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对于疫苗反应原性及其他不良事件，我们将采用Fisher精确检验或卡方检验进行组间比较。
任何亚组（如年龄分层、感染史）之间的比较均将采用多重性校正。
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疫苗接种后的9个月内将评估反应原性及其他偶发不良事件。
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在接种COVID疫苗后的八个月内，参与者报告检测阳性（抗原和/或PCR）SARS-CoV-2感染的频率（在两种已获许可的COVID-19平台——重组和mRNA之间进行比较）及其症状模式的评估
大体时间：接种后9个月内。
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在接种COVID-19疫苗后的八个月内，将使用Fisher精确检验或卡方检验比较研究组间参与者报告检测阳性感染的频率。 任何亚组（例如年龄分层、感染史）之间的比较将使用多重性调整。 将使用Fisher精确检验或卡方检验比较研究组间自我报告的COVID-19症状严重程度（中度或以上严重程度的百分比）和疾病持续时间（天数）。 任何亚组（例如年龄分层、感染史）之间的比较将使用多重性调整。 |
接种后9个月内。
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抗原制图与抗体景观
大体时间：抗原制图研究可在接种前及接种后30天（+/- 10天）获取的中和抗体滴度数据基础上进行。
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FDA合作者可能通过抗原图谱和抗体地形图来可视化疫苗与连续变体之间的抗原漂移，利用研究团队先前使用的分析方法。
这些分析利用中和抗体反应的相对差异来生成二维图谱（抗原图谱）或三维地形图，使人们能够评估不同病毒株之间的抗原相似性。
抗体地形图是有用的工具，可以捕捉个体在多次连续抗原暴露中的差异，用于比较接受重组疫苗或mRNA疫苗的个体之间的抗体滴度和广度（参见Wang等人的示例，Cell Host Microbe, 2022）。
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抗原制图研究可在接种前及接种后30天（+/- 10天）获取的中和抗体滴度数据基础上进行。
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Salivary and nasopharyngeal IgG and IgA antibody levels to vaccine SARS-CoV-2 strain and dominant SARS-CoV-2 circulating strain at 30 days and 5 months post vaccination
大体时间：These antibody tests will be conducted on biosamples obtained just prior to vaccination and 30 days (+/- 10 days) and 5 months (+/- 10 days) after vaccination.
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Salivary and nasopharyngeal IgG and IgA antibody levels to vaccine SARS-CoV-2 strain and dominant SARS-CoV-2 circulating strain at 30 days and 5 months post vaccination will be compared between the study arms using GMT and GSD.
T-tests will compare responses across two SARS-CoV-2 variants (i.e., the vaccine variant and the dominant circulating variant at the time of vaccination), stratified by vaccine type and adjusted for multiple comparisons (e.g., a Tukey's adjustment).
A non-parametric comparison can be used if there is non-normally distributed data despite the use of GMT, these approaches also account for multiplicity (e.g., Kruskall-Wallis with a Dunn's adjustment for multiplicity adjustment).
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These antibody tests will be conducted on biosamples obtained just prior to vaccination and 30 days (+/- 10 days) and 5 months (+/- 10 days) after vaccination.
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Quantify frequencies of spike-specific T cells, other T-cell immunity characteristics, and B cell immunity markers pre-vaccination, 30 days post-vaccination, and 5 months post-vaccination
大体时间：30 days (+/- 10 days) post-vaccination, and 5 months (+/- 10 days) post-vaccination
|
Quantify frequencies of spike-specific T cells, other T-cell immunity characteristics, and B cell immunity markers pre-vaccination, 30 days post-vaccination, and 5 months post-vaccination
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30 days (+/- 10 days) post-vaccination, and 5 months (+/- 10 days) post-vaccination
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Edward Mitre, MD、Uniformed Services University of the Health Sciences
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Sanchez JL, Cooper MJ, Myers CA, Cummings JF, Vest KG, Russell KL, Sanchez JL, Hiser MJ, Gaydos CA. Respiratory Infections in the U.S. Military: Recent Experience and Control. Clin Microbiol Rev. 2015 Jul;28(3):743-800. doi: 10.1128/CMR.00039-14.
- McLeod C, Dymock M, Flanagan KL, Plebanski M, Marshall H, Estcourt MJ, Tjiam MC, Blyth CC, Subbarao K, Mordant FL, Nicholson S, Faust SN, Wadia U, Thornton RB, Ellis Z, Mckenzie A, Marsh JA, Snelling TL, Richmond P. The Platform Trial In COVID-19 Priming and BOOsting (PICOBOO): The immunogenicity, reactogenicity, and safety of different COVID-19 vaccinations administered as a second booster (fourth dose) in AZD1222 primed individuals aged 50-<70 years old. J Infect. 2024 Dec;89(6):106286. doi: 10.1016/j.jinf.2024.106286. Epub 2024 Sep 26.
- National Center for Advancing Translational Sciences. Serious adverse events. Available at ht tps://toolkit.ncats.nih.gov/glossary/serious-adverse-event/; accessed 2 January 2025.
- Wang W, Lusvarghi S, Subramanian R, Epsi NJ, Wang R, Goguet E, Fries AC, Echegaray F, Vassell R, Coggins SA, Richard SA, Lindholm DA, Mende K, Ewers EC, Larson DT, Colombo RE, Colombo CJ, Joseph JO, Rozman JS, Smith A, Lalani T, Berjohn CM, Maves RC, Jones MU, Mody R, Huprikar N, Livezey J, Saunders D, Hollis-Perry M, Wang G, Ganesan A, Simons MP, Broder CC, Tribble DR, Laing ED, Agan BK, Burgess TH, Mitre E, Pollett SD, Katzelnick LC, Weiss CD. Antigenic cartography of well-characterized human sera shows SARS-CoV-2 neutralization differences based on infection and vaccination history. Cell Host Microbe. 2022 Dec 14;30(12):1745-1758.e7. doi: 10.1016/j.chom.2022.10.012. Epub 2022 Oct 21.
- Wang W, Bhushan G, Paz S, Stauft CB, Selvaraj P, Goguet E, Bishop-Lilly KA, Subramanian R, Vassell R, Lusvarghi S, Cong Y, Agan B, Richard SA, Epsi NJ, Fries A, Fung CK, Conte MA, Holbrook MR, Wang TT, Burgess TH, Pollett SD, Mitre E, Katzelnick LC, Weiss CD. Human and hamster sera correlate well in identifying antigenic drift among SARS-CoV-2 variants, including JN.1. J Virol. 2024 Nov 19;98(11):e0094824. doi: 10.1128/jvi.00948-24. Epub 2024 Oct 4.
- Conner TL, Goguet E, Haines-Hull H, et al: Subclinical SARS-CoV-2 Infections and Endemic Human Coronavirus Immunity Shape SARS-CoV-2 Saliva Antibody Responses. MedRxiv 2024; doi .org/10.1101/2024.05.22.24307751.
- Laing ED, Weiss CD, Samuels EC, Coggins SA, Wang W, Wang R, Vassell R, Sterling SL, Tso MS, Conner T, Goguet E, Moser M, Jackson-Thompson BM, Illinik L, Davies J, Ortega O, Parmelee E, Hollis-Perry M, Maiolatesi SE, Wang G, Ramsey KF, Reyes AE, Alcorta Y, Wong MA, Lindrose AR, Duplessis CA, Tribble DR, Malloy AMW, Burgess TH, Pollett SD, Olsen CH, Broder CC, Mitre E. Durability of Antibody Response and Frequency of SARS-CoV-2 Infection 6 Months after COVID-19 Vaccination in Healthcare Workers. Emerg Infect Dis. 2022 Apr;28(4):828-832. doi: 10.3201/eid2804.212037. Epub 2022 Feb 24.
- Jackson-Thompson BM, Goguet E, Laing ED, Olsen CH, Pollett S, Hollis-Perry KM, Maiolatesi SE, Illinik L, Ramsey KF, Reyes AE, Alcorta Y, Wong MA, Davies J, Ortega O, Parmelee E, Lindrose AR, Moser M, Graydon E, Letizia AG, Duplessis CA, Ganesan A, Pratt KP, Malloy AM, Scott DW, Anderson SK, Snow AL, Dalgard CL, Powers JH 3rd, Tribble D, Burgess TH, Broder CC, Mitre E. Prospective Assessment of SARS-CoV-2 Seroconversion (PASS) study: an observational cohort study of SARS-CoV-2 infection and vaccination in healthcare workers. BMC Infect Dis. 2021 Jun 9;21(1):544. doi: 10.1186/s12879-021-06233-1.
- U.S. Food and Drug Administration. Highlights of prescribing information: COMIRNATY® (COVID-19 Vaccine, mRNA) suspension for injection, for intramuscular use. 2024. Available at ht tps://www.fda.gov/media/151707/download; accessed 2 January 2025.
- U.S. Food and Drug Administration. Fact Sheet for healthcare providers administering vaccine: Emergency Use Authorization of Novavax COVID-19 Vaccine, adjuvanted (2024 - 2025 formula), for individuals 12 years of age and older. 2024. Available at https://www.fda.gov /media/159897/download; accessed 2 January 2025.
- Fong Y, Huang Y, Benkeser D, Carpp LN, Anez G, Woo W, McGarry A, Dunkle LM, Cho I, Houchens CR, Martins K, Jayashankar L, Castellino F, Petropoulos CJ, Leith A, Haugaard D, Webb B, Lu Y, Yu C, Borate B, van der Laan LWP, Hejazi NS, Randhawa AK, Andrasik MP, Kublin JG, Hutter J, Keshtkar-Jahromi M, Beresnev TH, Corey L, Neuzil KM, Follmann D, Ake JA, Gay CL, Kotloff KL, Koup RA, Donis RO, Gilbert PB; Immune Assays Team; Coronavirus Vaccine Prevention Network (CoVPN)/2019nCoV-301 Principal Investigators and Study Team; United States Government (USG)/CoVPN Biostatistics Team. Immune correlates analysis of the PREVENT-19 COVID-19 vaccine efficacy clinical trial. Nat Commun. 2023 Jan 19;14(1):331. doi: 10.1038/s41467-022-35768-3.
- Weitzman ER, Sherman AC, Levy O. SARS-CoV-2 mRNA Vaccine Attitudes as Expressed in U.S. FDA Public Commentary: Need for a Public-Private Partnership in a Learning Immunization System. Front Public Health. 2021 Jul 16;9:695807. doi: 10.3389/fpubh.2021.695807. eCollection 2021.
- Biggs AT, Littlejohn LF. Describing mRNA Vaccine Technology for a Military Audience. Mil Med. 2023 Mar 20;188(3-4):547-554. doi: 10.1093/milmed/usac129.
- Marchese AM, Rousculp M, Macbeth J, Beyhaghi H, Seet BT, Toback S. The Novavax Heterologous Coronavirus Disease 2019 Booster Demonstrates Lower Reactogenicity Than Messenger RNA: A Targeted Review. J Infect Dis. 2024 Aug 16;230(2):e496-e502. doi: 10.1093/infdis/jiad519.
- Scher AI, Berjohn CM, Byrne C, Colombo RE, Colombo CJ, Edwards MS, Ewers EC, Ganesan A, Jones M, Larson DT, Libraty D, Lindholm DA, Madar CS, Maldonado CJ, Maves RC, Mende K, Richard SA, Rozman JS, Rusiecki J, Smith A, Simons M, Tribble D, Agan B, Burgess TH, Pollett SD; EPICC COVID-19 Cohort Study Group. An Analysis of SARS-CoV-2 Vaccine Reactogenicity: Variation by Type, Dose, and History, Severity, and Recency of Prior SARS-CoV-2 Infection. Open Forum Infect Dis. 2022 Jun 28;9(7):ofac314. doi: 10.1093/ofid/ofac314. eCollection 2022 Jul.
- U.S. Food and Drug Administration. FDA Briefing Document. Vaccines and Related Biological Products Advisory Committee Meeting June 5, 2024. 2024. Available at https://www.fda.gov /media/179003/download; accessed 10 October 2024.
- U.S. Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee June 5, 2024 Meeting Announcement. 2024. Available at https://www.fda.gov /advisory-committees/advisory-committee-calendar/vaccines-and-related-biological- products-advisory-committee-june-5-2024-meeting-announcement; accessed 10 October 2024.
- Winkler EL, Stahlman SL, Wells NY, Chauhan AV, Hiban KM, Costello AA, Mancuso JD. COVID-19 Booster Vaccination in the U.S. Military, August 2021-January 2022. Am J Prev Med. 2023 Feb;64(2):270-274. doi: 10.1016/j.amepre.2022.07.017. Epub 2022 Aug 29.
- Centers for Disease Control and Prevention. ACIP Evidence to Recommendations (EtR) for Use of 2024-2025 COVID-19 Vaccines in Persons ≥6 Months of Age. 2024. Available at https:// www.cdc.gov/vaccines/acip/recs/grade/covid-19-2024-2025-6-months-and-older-etr. html; accessed 10 October 2024.
- Centers for Disease Control and Prevention. Staying Up to Date with COVID-19 Vaccines. 2024. Available at https://www.cdc.gov/covid/vaccines/stay-up-to-date.html; accessed 10 October 2024.
- Lam ICH, Zhang R, Man KKC, Wong CKH, Chui CSL, Lai FTT, Li X, Chan EWY, Lau CS, Wong ICK, Wan EYF. Persistence in risk and effect of COVID-19 vaccination on long-term health consequences after SARS-CoV-2 infection. Nat Commun. 2024 Feb 26;15(1):1716. doi: 10.1038/s41467-024-45953-1.
- Richard SA, Scher AI, Rusiecki J, Byrne C, Berjohn CM, Fries AC, Lalani T, Smith AG, Mody RM, Ganesan A, Huprikar N, Colombo RE, Colombo CJ, Schofield C, Lindholm DA, Mende K, Morris MJ, Jones MU, Flanagan R, Larson DT, Ewers EC, Bazan SE, Saunders D, Maves RC, Livezey J, Maldonado CJ, Edwards MS, Rozman JS, O'Connell RJ, Simons MP, Tribble DR, Agan BK, Burgess TH, Pollett SD; EPICC COVID-19 Cohort Study Group. Decreased Self-reported Physical Fitness Following SARS-CoV-2 Infection and the Impact of Vaccine Boosters in a Cohort Study. Open Forum Infect Dis. 2023 Nov 17;10(12):ofad579. doi: 10.1093/ofid/ofad579. eCollection 2023 Dec.
- Hone E, Pollett SD, Richard SA, et al, editors. The Molecular Epidemiology and Congregate Transmission Dynamics of Acute Respiratory Infections (ARIs) at United States Naval Academy (USNA) during Plebe Summer. Poster #113. Military Health System Research Symposium; 2024; Kissimmee, FL.
- Taylor CA, Patel K, Pham H, Kirley PD, Kawasaki B, Meek J, Witt L, Ryan PA, Reeg L, Como-Sabetti K, Domen A, Anderson B, Bushey S, Sutton M, Talbot HK, Mendez E, Havers FP; COVID-NET Surveillance Team. COVID-19-Associated Hospitalizations Among U.S. Adults Aged >/=18 Years - COVID-NET, 12 States, October 2023-April 2024. MMWR Morb Mortal Wkly Rep. 2024 Oct 3;73(39):869-875. doi: 10.15585/mmwr.mm7339a2.
- National Center for Health Statistics. Provisional COVID-19 Mortality Surveillance. Centers for Disease Control and Prevention; 2024. Available at https://www.cdc.gov/nchs/nvss/vsrr /covid19/index.htm; accessed 10 October 2024.
- Kasper MR, Geibe JR, Sears CL, Riegodedios AJ, Luse T, Von Thun AM, McGinnis MB, Olson N, Houskamp D, Fenequito R, Burgess TH, Armstrong AW, DeLong G, Hawkins RJ, Gillingham BL. An Outbreak of Covid-19 on an Aircraft Carrier. N Engl J Med. 2020 Dec 17;383(25):2417-2426. doi: 10.1056/NEJMoa2019375. Epub 2020 Nov 11.
- Mease LE, Smith AM. Surveillance snapshot: A simple model estimating the impact ofCOVID-19 on lost duty days among U.S. service members. MSMR. 2021 Sep 1;28(9):17. No abstract available.
- U.S. Department of Defense. Coronavirus: DoD Response. 2024. Available at https://www. defense.gov/Spotlights/Coronavirus-DOD-Response/; accessed 8 October 2024.
- Absolute and relative morbidity burdens attributable to various illnesses and injuries, active component, U.S. Armed Forces, 2020. MSMR. 2021 May;28(5):2-9. No abstract available.
- Gray GC, Callahan JD, Hawksworth AW, Fisher CA, Gaydos JC. Respiratory diseases among U.S. military personnel: countering emerging threats. Emerg Infect Dis. 1999 May-Jun;5(3):379-85. doi: 10.3201/eid0503.990308.
- Absolute and Relative Morbidity Burdens Attributable to Various Illnesses and Injuries Among Active Component Members of the U.S. Armed Forces, 2023. 2024. Available at https://www. health.mil/News/Articles/2024/06/01/MSMR-Health-Care-Burden-Active-Component; accessed 10 October 2024.
- Absolute and Relative Morbidity Burdens Attributable to Various Illnesses and Injuries Among Non-Service Member Beneficiaries of the Military Health System, 2023. 2024. Available at https: //health.mil/News/Articles/2024/07/01/MSMR-MHS-Beneficiaries-2023; accessed 10 October 2024.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年11月12日
初级完成 (估计的)
2027年9月1日
研究完成 (估计的)
2027年9月1日
研究注册日期
首次提交
2025年11月18日
首先提交符合 QC 标准的
2025年12月11日
首次发布 (实际的)
2025年12月17日
研究记录更新
最后更新发布 (实际的)
2026年9月11日
上次提交的符合 QC 标准的更新
2026年9月8日
最后验证
2026年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.