南京预防性呼吸道合胞病毒疫苗III期临床试验-一项呼吸道合胞病毒疫苗预防60岁及以上成人下呼吸道疾病的研究

登记号	CTR20221418	试验状态	进行中
申请人联系人	杨晓煜	首次公示信息日期	2022-06-13
申请人名称	Janssen Vaccines & Prevention B.V./ 强生（中国）投资有限公司/ 1. IDT Biologika GmbH；2. Janssen Vaccines Corporation/ 1. Fisher Clinical Services GmbH；2. Fisher Clinical Services Allentown；3. Catalent Germany Schorndorf GmbH；4. Catalant；5.Janssen R&D, A division of Janssen Pharmaceutica NV；6. Catalent Pharma Solutions

登记号	CTR20221418
相关登记号	暂无
药物名称	预防性呼吸道合胞病毒疫苗
药物类型	生物制品
临床申请受理号	企业选择不公示
适应症	本品适用于预防60岁及以上的成年人呼吸道合胞病毒引起的下呼吸道疾病
试验专业题目	一项使用基于Ad26.RSV.preF的疫苗预防≥60岁成人中由RSV引起的下呼吸道疾病的随机、双盲、安慰剂对照、3期有效性研究
试验通俗题目	一项呼吸道合胞病毒疫苗预防60岁及以上成人下呼吸道疾病的研究
试验方案编号	VAC18193RSV3001	方案最新版本号	修正案3/中国版修正案4
版本日期:	2022-04-13	方案是否为联合用药	否

申请人名称	1 2 3 4
联系人姓名	杨晓煜	联系人座机	021-33378730	联系人手机号	18818211895
联系人Email	xyang160@its.jnj.com	联系人邮政地址	上海市-上海市-徐汇区桂箐路65号新研大厦6楼	联系人邮编	200233

证明基于Ad26.RSV.preF的研究疫苗与安慰剂相比在预防≥60岁成人经逆转录酶聚合酶链反应（RT-PCR）确认的RSV所致下呼吸道疾病（LRTD）的有效性。

试验分类	安全性和有效性	试验分期	III期	设计类型	平行分组
随机化	随机化	盲法	双盲	试验范围	国际多中心试验

年龄	60岁(最小年龄)至 无上限 (最大年龄)
性别	男+女
健康受试者	有
入选标准	1 必须签署ICF，表明其理解研究的目的、程序及潜在风险和获益并愿意参加研究。 2 愿意并能够遵循本方案规定的禁忌和限制事项。 3 签署ICF当天年龄必须≥60岁，预计能够在研究期间腾出时间。 4 在随机化之前，受试者必须：n绝经后（绝经后状态定义为停经12个月，且无其他医学原因）；n不打算通过任何方法怀孕。n注：子宫切除的受试者也有资格参加研究。 5 受试者在接种疫苗时必须保持稳定的健康状况（根据研究者的临床判断）。某些受试者可能患有高血压、CHF、COPD、2型糖尿病、高脂蛋白血症或甲状腺功能减退症等基础疾病，但只要接种疫苗时研究者判断其症状和体征稳定且医学可控，同时受试者的医疗保健提供机构会对其进行常规随访，这些受试者就有资格参加研究。将根据受试者的病史及其在ICF签署后、疫苗接种前的生命体征决定是否将其纳入研究。n注：第12个月复种时，受试者的健康状况必须保持稳定（根据研究者的判断）。某些受试者可能患有基础疾病，但只要复种时研究者判断其症状和体征稳定且医学可控。 6 同意从疫苗接种开始至接种后3个月不献血。 7 必须能够阅读、理解并完成电子日志中的问卷。 8 必须愿意在研究过程中提供可验证的身份证明、联系方式并愿意与研究者联系。 9 必须能够使用智能手机/平板电脑/计算机。
排除标准	1 患有严重的临床不稳定型疾病（如需要或不需要透析的终末期肾病、临床不稳定型心脏疾病）、阿尔茨海默病或其他任何研究者认为参加研究不符合受试者的最佳利益或可能妨碍、混淆或限制方案特定评估的疾病。 2 筛选或复种前5年内有恶性肿瘤史，但以下情况除外：na. 由研究者决定，可入组患有皮肤鳞状细胞癌和皮肤基底细胞癌以及宫颈原位癌的受试者。nb. 根据研究者的判断，可入组5年内有恶性肿瘤病史但已治愈且复发风险极小的受试者。 3 根据研究者的判断，受试者在疫苗接种前4周内接受过重大手术（如重大心肺或腹部手术），或研究期间无法从之前的手术中完全恢复，或计划在参加研究期间进行重大手术。 4 由以下情况引起的免疫系统功能异常：na. 存在预期会影响研究疫苗诱导的免疫应答的临床状况（例如，自身免疫性疾病或免疫缺陷）。n由研究者决定，可入组在不使用全身性免疫调节剂和糖皮质激素的情况下疾病稳定且非活动性的自身免疫性疾病（例如，自身免疫性甲状腺疾病、自身免疫性炎症性风湿性疾病[如类风湿性关节炎和1型糖尿病]）受试者。nb. 在研究疫苗接种前2个月内和研究期间，长期或反复使用全身性皮质类固醇。有显著免疫抑制作用的类固醇剂量为≥2周每天接受20mg泼尼松或等效药物。n注：允许使用眼用、局部、关节内或吸入性类固醇。nc. 在研究疫苗接种前6个月内和研究期间接受抗肿瘤药和免疫调节剂（例如，癌症化疗药物）或放疗。n注：允许使用眼部和局部抗肿瘤药物和免疫调节剂。 5 接种过或计划接种：na. 获批的减毒活疫苗 - 在计划的研究疫苗接种前后28天内。nb. 其他获批的（非活）疫苗 - 在计划的研究疫苗接种前后14天内。 6 在研究疫苗接种前24小时内出现急性疾病（包括急性呼吸道疾病）或体温≥37.0℃（腋温）。n注：允许延后入组。 7 有重大精神疾病和/或药物或酒精滥用，研究者认为会损害受试者的安全性和/或研究程序依从性。 8 已知或疑似对疫苗或疫苗组分（包括研究疫苗的任何成分）过敏或有速发过敏反应史或其他严重不良反应史。请参见Ad26/蛋白preF RSV疫苗最新版研究者手册 (IB Ad26/protein preF RSV vaccine 2021)及研究者手册增补（如适用）。 9 有急性多发性神经病（例如，格林巴利综合征）史或慢性特发性脱髓鞘性多发神经病（CIDP）史。 10 病史显示接受过造血干细胞移植，在计划的研究疫苗接种前2个月内接受过免疫球蛋白治疗，前12个月内接受过RSV、hMPV或副流感病毒特异性免疫球蛋白治疗，前4个月内接受过血液单采或血液制品治疗，或计划在研究期间接受上述治疗。n注：允许在研究疫苗给药前和研究实施期间使用单抗药物，靶向T细胞（抗CD3、CD4、CD33和CD52）、B细胞（抗CD45、CD19、CD20、CD22、CD27、CD38和CD138）和检查点抑制剂（PD-1、PDL-1和CTLA-4）的单抗除外。禁用的单抗有：莫罗单抗-CD3（Muromonab-CD3）、吉妥单抗（gemtuzumab ozogamicin）、阿仑单抗、贝伐单抗、利妥昔单抗、奥法木单抗、奥珠单抗、托西莫单抗、维妥珠单抗（veltuzumab）、奥滨尤妥珠单抗（obinutuzumab）、依帕珠单抗、派姆单抗、纳武单抗、阿特珠单抗、阿维鲁单抗（avelumab）、度伐利尤单抗（durvalumab）和靶向伊匹木单抗的CTLA-4。在计划的研究疫苗给药前2个月内接受了这些单抗的受试者或计划在研究期间接受这些单抗的受试者将被排除在研究之外。 11 在计划的研究疫苗接种前30天内接受过试验用药物或使用过侵入性试验用医疗器械，前6个月内接受过试验用疫苗，或目前已入组或计划在本研究期间参加另一项临床研究。n注：经申办方或其代表批准后，可入组正在参加观察性临床研究（即无干预）或干预性研究观察期的受试者。 12 有肌内注射和采血禁忌（例如，出血性疾病）。 13 在既往RSV疫苗研究中接种过RSV疫苗。 14 按照修正案1将此标准删除 15 为研究者或研究中心的雇员，会直接参与本研究或本研究研究者或研究中心负责的其他研究，或为这些雇员或研究者的家属，或为申办方的雇员。 16 研究者认为受试者不太可能依从研究要求或不太可能完成整个接种和观察过程。 17 无法与研究者进行可靠的沟通。 18 受试者双臂三角肌区域存在明显瘢痕、纹身、擦伤、割伤或感染，研究者认为可能干扰注射部位局部反应评价。 19 接种过或计划接种SARS-CoV-2疫苗：na 减毒SARS-CoV-2活疫苗（在计划的研究疫苗首次或后续接种前后28天内接种）。nb 非活SARS-CoV-2活疫苗（在计划的研究疫苗首次或后续接种前后14天内接种）。nc 病毒载体SARS-CoV-2疫苗（在计划的研究疫苗首次或后续接种前后28天内接种）。 20 在随机化前至每次研究疫苗接种后28天内的任何时间接种了或计划接种Ad26载体疫苗（不适用于SARS-CoV-2疫苗；请参见排除标准19）。 21 有TTS或肝素诱导性血小板减少症和血栓形成（HITT）病史。n注：研究者应确保在首次接种之前受试者满足所有研究入组标准。如果筛选后至研究疫苗接种前受试者的临床状态发生改变（包括任何已有的实验室检查结果或者收到更多医疗记录显示改变），导致其不再符合所有入排标准，那么该受试者将被排除在研究之外。支持满足入组标准的所需文件参见附录2：监管、伦理和研究监督考量中的“源文件”。

试验药	序号 名称 用法 1 中文通用名:预防性呼吸道合胞病毒疫苗(Ad26/蛋白preFRSV疫苗) 英文通用名:ProphylacticRSVVaccine(Ad26/proteinpreFRSVVaccine) 商品名称:NA 剂型:注射剂 规格:Ad26.RSV.preF2E11VP/mL,RSVpreF0.3mg/ml 用法用量:肌肉注射1.0mL 用药时程:单次给药
对照药	序号 名称 用法 1 中文通用名:Ad26.RSV.preF和RSVpreF蛋白的安慰剂 英文通用名:PlaceboforAd26.RSV.preFandforRSVpreFprotein. 商品名称:NA 剂型:注射剂 规格:0.9%w/v氯化钠10mL 用法用量:肌肉注射1.0mL 用药时程:单次给药

主要终点指标及评价时间

序号 指标 评价时间 终点指标选择 1 发生经逆转录聚合酶链反应（RT-PCR）确认的呼吸道合胞体病毒（RSV）所致下呼吸道疾病（LRTD）的受试者百分比 直到19个月 有效性指标

次要终点指标及评价时间

序号 指标 评价时间 终点指标选择 1 在第一个RSV季节期间，发生任何经RT-PCR确认的RSV所致ARI的百分比 直到9个月 有效性指标 2 在整个研究期间，经RT-PCR确认的RSV所致LRTD的受试者百分比 直到21个月 有效性指标 3 在整个研究中，RT-PCR 确认 RSV 介导的急性呼吸道感染 (ARI) 的参与者百分比 直到21个月 有效性指标 4 严重不良事件（SAE）的发生率 直到21个月 安全性指标 5 特别关注的不良事件（AESI）的发生率 直到21个月 安全性指标 6 有征集性局部不良事件（AE）的发生率 接种7天后（第8天到第373天） 安全性指标 7 有征集性全身 AE 的受试者百分比 接种7天后（第8天和第373天） 安全性指标 8 非征集性AE的发生率 接种28天后（第29天和第393天） 安全性指标 9 RSV 中和抗体水平 直到21个月 有效性指标 10 通过酶联免疫吸附测定（ELISA）的RSV前F蛋白和后F蛋白结合抗体 直到21个月 有效性指标 11 干扰素 γ （IFN-γ） 酶联免疫斑 （ELISpot） 测定 直到21个月 有效性指标

1	姓名	朱凤才	学位	医学硕士	职称	主任医师
	电话	13851994867	Email	jszfc@jscdc.cn	邮政地址	江苏省-南京市-南京市江苏路172号
	邮编	210009	单位名称	江苏省疾病预防控制中心

序号	机构名称	主要研究者	国家	省（州）	城市
1	江苏省疾病预防控制中心	朱凤才	中国	江苏省	南京市
2	Paratus Clinical Kanwal Clinic	Kim, Joshua	Australia	New South Wales	Kanwal
3	Northside Health	Voloshyna, Olga	Australia	New South Wales	Coffs Harbour
4	Paratus Clinical Canberra Clinic	Leah, Amber	Australia	Austl. Cap. Terr.	Bruce
5	Mater Hospital Brisbane	Griffin, Paul	Australia	Queensland	South Brisbane
6	CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos	Barranjard Vannucci Lomonte, Andrea	Brazil	Sao Paulo	Sao Paulo
7	CMiP - Centro Mineirode Pesquisa	de Souza, Rodrigo Daniel	Brazil	Minas Gerais	Juiz de Fora
8	FACULDADE DE MEDICINA DO ABC	Fiss, Elie	Brazil	Sao Paulo	Santo Andre
9	CEMEC - Centro Multidisciplinar de Estudos Clinicos	Francisco Pez, Andreia Luisa	Brazil	Sao Paulo	Sao Bernardo do Campo
10	UFRR - Universidade Federal de Roraima	Jardim da Fonseca, Allex	Brazil	Roraima	Boa Vista
11	Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto	Lacerda Nogueira, Mauricio	Brazil	Sao Paulo	Sao Jose do Rio Preto
12	HOSPITAL DE CLINICAS DE PORTOALEGRE	Zubaran Goldani, Luciano	Brazil	Rio Grande do Sul	Porto Alegre
13	Nucleo de Medicina Tropical - Universidade Federal do Ceara	Castelo Branco Coelho, Ivo	Brazil	Ceara	Fortaleza
14	CPQuali Pesquisa Clinica LTDA ME	Delano Bronstein, Marcello	Brazil	Sao Paulo	Sao Paulo
15	Hospital Gloria D'Or -Hospitais Integrados da Gavea S/A	Cerbino Neto, Jose	Brazil	Rio de Janeiro	Rio de Janeiro
16	Hospital Sao Lucas da PUCRS	Ramos, Fabiano	Brazil	Rio Grande do Sul	Porto Alegre
17	LMC Clinical Research dba Manna Research Inc. Quebec City	Blouin, Francois	Canada	Quebec	Levis
18	LMC Clinical Research dba Manna Research Inc. Montreal	Garg, Naveen	Canada	Quebec	Pointe Claire
19	LMC Clinical Research dba Manna Research Inc. Toronto	Vale, Noah	Canada	Ontario	Toronto
20	LMC Clinical Research dba Manna Research Inc. Burlington	Salter, Timothy	Canada	Ontario	Burlington
21	LMC Clinical Research Inc. (Bayview)	Abitbol, Alexander	Canada	Ontario	Toronto
22	DIEX Recherche Victoriaville Inc.	Bellavance, Ethel	Canada	Quebec	Victoriaville
23	DIEX Recherche Quebec Inc.	Frechette, Andre	Canada	Quebec	Quebec
24	DIEX Recherche Sherbrooke Inc.	Girard, Ginette	Canada	Quebec	Sherbrooke
25	Okanagan Clinical Trials	Maytham, Colleen	Canada	British Columbia	Kelowna
26	DIEX Recherche Joliette Inc.	Paquette, Jean Sebastien	Canada	Quebec	Saint-Charles-Borromee
27	CENRESIN	Pavie, Juana Rosa	Chile	NA	Quilota
28	Centro de Estudios Clinicos e Investigacion Medica (CeCim)	Saavedra Pacheco, Carla Constanza	Chile	Region Met	Santiago
29	Centro de Investigacion del Maule	Silva Orellana, Rafael	Chile	NA	Talca
30	Clinical Research Centre	Poder, Airi	Estonia	NA	Tartu
31	OU Innomedica	Talli, Jaak	Estonia	NA	Tallinn
32	Center for Clinical and Basic Research	Valter, Ivo	Estonia	NA	Tallinn
33	Jarvenpaan rokotetutkimusklinikka	Peltonen, Lauri	Finland	NA	Jarvenpaa
34	Turun rokotetutkimusklinikka	Seppa, Ilkka	Finland	NA	Turku
35	Etela-Helsingin rokotetutkimusklinikka	Koski, Susanna	Finland	NA	Helsinki
36	Oulun rokotetutkimusklinikka	Kokko, Satu	Finland	NA	Oulu
37	Seinajoen rokotetutkimusklinikka	Laajalahti, Outi	Finland	NA	Seinajoki
38	Kokkolan rokotetutkimusklinikka	Paavola, Pauliina	Finland	NA	Kokkola
39	Porin rokotetutkimusklinikka	Seppa, Ilkka	Finland	NA	Pori
40	Tampereen rokotetutkimusklinikka	Seppa, Ilkka	Finland	NA	Tampere
41	Ita-Helsingin rokotetutkimusklinikka	Koski, Susanna	Finland	NA	Helsinki
42	Espoon rokotetutkimusklinikka	Ukkonen, Benita	Finland	NA	Espoo
43	North Manchester General Hospital	Uriel, Alison	United Kingdom Of Great Britain And Northern Ireland	Greater Manchester	Manchester
44	Synexus Hexham General Hospital	Iyengar, Shalini	United Kingdom Of Great Britain And Northern Ireland	Northumberland	Hexham
45	Synexus Midlands Clinical Research Centre	Faulkner, Karen	United Kingdom Of Great Britain And Northern Ireland	West Midlands	Birmingham
46	Synexus Merseyside Clinical Research Centre	Ozunlu, Pembe	United Kingdom Of Great Britain And Northern Ireland	Merseyside	Liverpool
47	Synexus Scotland Clinical Research Centre	Munsoor, Imrozia	United Kingdom Of Great Britain And Northern Ireland	North Lanarkshire	Glasgow
48	Synexus Wales Clinical Research Center	Nicholls, Helen	United Kingdom Of Great Britain And Northern Ireland	South Glamorgan	Cardiff
49	Synexus Lancashire Clinical Research Centre	Munthali, Chigomezgo	United Kingdom Of Great Britain And Northern Ireland	Lancashire	Chorley
50	Synexus Manchester Clinical Research Center	Viljoen, Marianne	United Kingdom Of Great Britain And Northern Ireland	Greater Manchester	Manchester
51	FutureMeds Bridle Clinic	Johnson, Martin	United Kingdom Of Great Britain And Northern Ireland	Merseyside	Bromborough
52	Panthera Biopartners	Rooney, Patrick	United Kingdom Of Great Britain And Northern Ireland	Strathclyde	Glasgow
53	Bradford Royal Infirmary	Saralaya, Dinesh	United Kingdom Of Great Britain And Northern Ireland	West Yorkshire	Bradford
54	Panthera Biopartners	Wickens, Olivia	United Kingdom Of Great Britain And Northern Ireland	Lancashire	Preston
55	FutureMeds Soho Health Centre	Johnson, Martin	United Kingdom Of Great Britain And Northern Ireland	West Midlands	Birmingham
56	Southern Clinical Trials, Christchurch	Carson, Simon	New Zealand	NA	Christchurch
57	Optimal Clinical Trials	Montgomery, Barnaby	New Zealand	NA	Auckland
58	Southern Clinical Trials, Waitemata	Smith, Susan	New Zealand	NA	Auckland
59	Lakeland Clinical Trials	Williams, Michael	New Zealand	NA	Rotorua
60	Southern Clinical Trials Tasman	Thurlow, Claire	New Zealand	NA	Main Road Stoke
61	Southern Clinical Trials Totara Clinical Research	King, Craig	New Zealand	NA	Auckland
62	P3 Research Limited Kapiti	Edwards, Andrew	New Zealand	NA	Paraparaumu
63	Lakeland Clinical Trials	Hemi, Tiwini	New Zealand	NA	Hamilton
64	Lakeland Clinical Trials	Humphrey, Tim	New Zealand	NA	Upper Hutt
65	P3 Research Ltd	Esquilant, Emma	New Zealand	NA	Havelock North
66	P3 Research Ltd	Kamerbeek, Jackie	New Zealand	NA	Tauranga
67	P3 Reaearch Wellington	Quinn, Dean	New Zealand	NA	Wellington
68	P3 Research Ltd	Edwards, Andrew	New Zealand	NA	Palmerston North
69	Synexus Polska Sp. z o.o. Oddzial w Warszawie	Dabrowska, Magda	Poland	NA	Warszawa
70	Synexus Polska Sp. z o.o. Oddzial w Gdansku	Cesarz, Marek	Poland	NA	Gdansk
71	Synexus Polska Sp. z o.o. Oddzial w Czestochowie	Janowicz, Anna	Poland	NA	Czestochowa
72	Synexus Polska Sp. z.o.o. Oddzial w Poznaniu	Kolodziejska, Elzbieta	Poland	NA	Poznan
73	Synexus Polska Sp. z o.o.	Olszewska-Jander, Magdalena	Poland	NA	Lodz
74	Synexus Polska Sp. z o.o. Oddzial w Katowicach	Sipinska-Surzynska, Malgorzata	Poland	NA	Katowice
75	Synexus Polska Sp. z o.o. Oddzial we Wroclawiu	Szymkowiak, Katarzyna	Poland	NA	Wroc？aw
76	KO-MED Centra Kliniczne Zamosc	Czochra, Wojciech	Poland	NA	Zamosc
77	KO-MED Centra Kliniczne Staszow	Wawrzyniec, Katarzyna	Poland	NA	Staszow
78	KO-MED Centra Kliniczne Pu？awy	Konieczny, Marek	Poland	NA	Pulawy
79	KO-MED Centra Kliniczne LUBLIN	Zelazowska, Katarzyna	Poland	NA	Lublin
80	Synexus Scm Sp. Z o.o. Oddzial Gdynia	Sein Anand, Izabela	Poland	NA	Gdynia
81	Centrum Medyczne Pratia Poznan	Kwiatek, Michal	Poland	NA	Skorzewo
82	Centrum Medyczne PRATIA Bydgoszcz	Losinska, Lucyna	Poland	NA	Bydgoszcz
83	Srinagarind Hospital	Meesing, Atibordee	Thailand	Muang	Khon Kaen
84	King Chulalongkorn Memorial Hospital	Tantawichien, Terapong	Thailand	Bangkok	Pathumwan
85	The Vaccine Trial Center(VTC), Faculty of Tropical Medicine	Muangnoicharoen, Sant	Thailand	Ratchathewi	Bangkok
86	Royal Thai Army,Afrims	Nitayaphan, Sorachai	Thailand	Bangkok	Rajathevi
87	Maharaj NakornChiang Mai hospital -Faculty of Medicine	Angkurawaranon, Chaisiri	Thailand	Chiang Mai	Muang
88	Siriraj Hospital	Chayakulkeeree, Methee	Thailand	Bangkok	Bangkok
89	Medpharmics, LLC	Jeanfreau, Robert	United States Of America	Louisiana	Kenner
90	Paradigm Clinical Research Centers, Inc.	Lupercio, Rafael	United States Of America	California	Redding
91	Rapid Medical Research	Briskin, Toby	United States Of America	Ohio	Cleveland
92	Regional Clinical Research, Inc.	Patel, Suchet	United States Of America	New York	Endwell
93	Avail Clinical Research, LLC	Rankin, Bruce	United States Of America	Florida	Deland
94	Advanced Clinical Research	Turner, Mark	United States Of America	Idaho	Boise
95	Meridian Clinical Research, LLC	Harper, Charles	United States Of America	Nebraska	Norfolk
96	MedPharmics - Biloxi	Matherne, Paul	United States Of America	Gulfport	Biloxi
97	Medication Management, LLC	Pharr, Walter	United States Of America	North Carolina	Greensboro
98	Jacksonville Center For Clinical Research	Jacqmein, Jeffry	United States Of America	Florida	Jacksonville
99	Hope Research Institute	Burgher, Abram	United States Of America	Arizona	Peoria
100	Advanced Clinical Research	Lucksinger, Gregg	United States Of America	Texas	Cedar Park
101	Meridian Clinical Research, LLC	Bradley, Paul	United States Of America	Georgia	Savannah
102	Harmony Clinical Research Inc	Debs-Perez, Giselle	United States Of America	Florida	North Miami Beach
103	Westside Center for Clinical Research	Downey, Herman	United States Of America	Florida	Jacksonville
104	Meridian Clinical Research, LLC	Eder, Frank	United States Of America	New York	Endwell
105	Meridian Clinical Research - Dakota Dunes	Ensz, David	United States Of America	Iowa	Dakota Dunes
106	Meridian Clinical Research - Omaha	Essink, Brandon	United States Of America	Nebraska	Omaha
107	Omega Medical Research	Fried, David	United States Of America	Rhode Island	Warwick
108	Lynn Health Science Institute	Griffin, Carl	United States Of America	Oklahoma	Oklahoma City
109	Wake Research Associates	Hong, Matthew	United States Of America	North Carolina	Raleigh
110	Synexus Clinical Research US, Inc	Adams, Michael	United States Of America	Utah	Murray
111	Clinical Research Consortium Arizona	Anderson, Corey	United States Of America	Arizona	Tempe
112	Optimal Research	Brune, Daniel	United States Of America	Illinois	Peoria
113	Synexus Clinical Research US, Inc	Severance, Randall	United States Of America	Arizona	Chandler
114	Synexus Clinical Research US, Inc	McGill, Lorrie	United States Of America	Nebraska	Omaha
115	Optimal Research	Kimmel, Murray	United States Of America	Florida	Melbourne
116	Synexus Clinical Research US, Inc	Starkey, Thomas	United States Of America	Colorado	Aurora
117	Heartland Clinical Research	Poling, Terry	United States Of America	Kansas	Wichita
118	Clinical Research Associates Inc	Sharp, Stephan	United States Of America	Tennessee	Nashville
119	Optimal Research	Ghosh, Rita	United States Of America	Maryland	Rockville
120	Heartland Research Associates, LLC	Rausch, Michael	United States Of America	Kansas	Augusta
121	The Center for Pharmaceutical Research (CPR)	Ervin, John	United States Of America	Missouri	Kansas City
122	Optimal Research	Middleton, Randle	United States Of America	Alabama	Huntsville
123	Synexus Clinical esearch US, Inc	Nugent, Paul	United States Of America	Ohio	Cincinnati
124	Central Phoenix Medical Clinic	Riffer, Ernie	United States Of America	Arizona	Phoenix
125	Coastal Carolina Research Center	Tangeman, Cayce	United States Of America	South Carolina	Mt. Pleasant
126	Synexus Clinical Research US, Inc	Choi, Melissa	United States Of America	Minnesota	Richfield
127	Synexus Clinical Research US, Inc	Tharenos, Leslie	United States Of America	Missouri	St Louis
128	Optimal Research	Yassini, Patrick	United States Of America	California	San Diego
129	Heartland Research Associates, LLC	Glover, Richard	United States Of America	Kansas	Newton
130	DM Clinical Research	Irfan, Muhammad	United States Of America	Texas	Tomball
131	The Iowa Clinic, P.C.	Jones, Kathleen	United States Of America	Iowa	West Des Moines
132	Martine Diagnostic Clinic	Martin, Earl	United States Of America	Texas	Tomball
133	Medpharmics, LLC	Plimpton, Charles	United States Of America	Arizona	Phoenix
134	Synexus Clinical Research US, Inc	Klein, Jeffrey	United States Of America	Ohio	Akron
135	Optimal Research	Vachris, Timothy	United States Of America	Texas	Austin
136	Synexus Clinical Research US, Inc	Meyer, Robert	United States Of America	Florida	Orlando
137	Trial Management Associates, LLC	Williams, Barton	United States Of America	North Carolina	Wilmington
138	PMG Research of Wilmington, LLC	Cannon, Kevin	United States Of America	North Carolina	Wilmington
139	Clinical Research Associates of Tidewater	Ellis, Kimberly	United States Of America	Virginia	Norfolk
140	Spartanburg Medical Research	Fogarty, Charles	United States Of America	South Carolina	Spartanburg
141	Paradigm Clinical Research Centers, Inc.	Elzi, Stanton	United States Of America	Colorado	Wheat Ridge
142	Prestige Clinical Research Center, Inc.	Junquera, Patricia	United States Of America	Florida	Coral Gables
143	Rancho Paseo Medical Group	Kasarjian, Julie	United States Of America	California	Banning
144	Heartland Clinical Research	Egelhof, Richard	United States Of America	Kansas	Wichita
145	Lynn Institute of Norman	Cox, Steven	United States Of America	Oklahoma	Norman
146	Suncoast Research Group	Kutner, Mark	United States Of America	Florida	Miami
147	Texas Center for Drug Development, Inc	Miller, Vicki	United States Of America	Texas	Houston
148	Central Kentucky Research Associates,Inc.	Adams, Mark	United States Of America	Kentucky	Lexington
149	Synexus Clinical Research US, Inc	Taylor, David	United States Of America	Georgia	Atlanta
150	Johnson County Clin-Trials	Fierro, Carlos	United States Of America	Kansas	Lenexa
151	Centennial Medical Group	Geller, Steven	United States Of America	Maryland	Elkridge
152	New Horizons Clinical Research	Powell, Richard	United States Of America	Ohio	Cincinnati
153	PMG Research of Bristol	Grunstra, Bernard	United States Of America	Tennessee	Bristol
154	Clinical Research Consortium, an AMR company	Jacobs, Michael	United States Of America	Nevada	Las Vegas
155	Synexus Clinical Research US, Inc	Jennings, William	United States Of America	Texas	San Antonio
156	PMG Research of Charleston, LLC	Mills, Richard	United States Of America	South Carolina	Mount Pleasant
157	Tekton Research Inc.	Pickrell, Paul	United States Of America	Texas	Austin
158	Preferred Primary Care Physicians Research	Purighalla, Raman	United States Of America	Pennsylvania	Pittsburgh
159	Tekton Research Inc.	Lockwood, Robert	United States Of America	Oklahoma	Yukon
160	Advanced Clinical Research	Rizzardi, Barbara	United States Of America	Utah	West Jordan
161	Clinical Research of South Florida, an AMR Company	Rosen, Jeffrey	United States Of America	Florida	Coral Gables
162	Velocity Clinical Research, Hallandale Beach	Vijil, Julio	United States Of America	Florida	Hallandale Beach
163	Clinical Research Atlanta	Finley, Jon	United States Of America	Georgia	Stockbridge
164	Coastal Clinical Research, Inc	Studdard, Harry	United States Of America	Alabama	Mobile
165	Sundance Clinical Research	Wadsworth, Larkin	United States Of America	Missouri	St. Louis
166	Compass Research LLC	Jenouri, Gilbert	United States Of America	Florida	Leesburg
167	JEM Research, LLC	Bush, Larry	United States Of America	Florida	Atlantis
168	Synexus Clinical Research US, Inc	Calinescu, Cornell	United States Of America	Nevada	Henderson
169	Medpharmics, LLC	Carr, Quito Osuna	United States Of America	New Mexico	Albuquerque
170	Synexus Clinical Research US, Inc	DeGrauw, Jeffery	United States Of America	Utah	Layton
171	VitaLink Research Spartanburg	Feldman, Gregory	United States Of America	South Carolina	Spartanburg
172	Synexus Clinical Research US, Inc	Greiwe, Cathy	United States Of America	Ohio	Columbus
173	Amherst Family Practice, PC	Houser, Patricia	United States Of America	Virginia	Winchester
174	Synexus Clinical Research US, Inc	Kirby, William	United States Of America	Alabama	Birmingham
175	Synexus Clinical Research US, Inc	Kopp, James	United States Of America	South Carolina	Anderson
176	Synexus Clinical Research US, Inc	Murray, Linda	United States Of America	Florida	Pinellas Park
177	Synexus Clinical Research US, Inc	Newberg, Joseph	United States Of America	Illinois	Chicago
178	Synexus Clinical Research US, Inc	Pounds, Kevin	United States Of America	Arizona	Tucson
179	Synexus Clinical Research US, Inc	Reynolds, Michele	United States Of America	Texas	Dallas
180	AMR Fort MyersClinical Physiology Associates, an AMR company	Ylisastigui, Pedro	United States Of America	Florida	Ft. Myers
181	Christie Clinic	Bartlett, Andrew	United States Of America	Illinois	Champaign
182	Headlands Research Orlando	Galloway, Christopher	United States Of America	Florida	Orlando
183	Preferred Primary Care Physicians Research	Hartley, Paul	United States Of America	Pennsylvania	Uniontown
184	Spectrum Medical, Inc	Jannach, Stephan	United States Of America	Virginia	Danville
185	Accellacare Research of Cary	Rubino, John	United States Of America	North Carolina	Raleigh
186	Centex Studies, Inc.	Whatley, Joshua	United States Of America	Louisiana	Lake Charles
187	Accellacare Research of Cary	Shoffner, Sylvia	United States Of America	North Carolina	Cary
188	VGR & NOCCR -Knoxville	Smith, William	United States Of America	Tennessee	Knoxville
189	Accellacare Research of Cary	Wilson, Jonathan	United States Of America	North Carolina	Winston-Salem
190	Encompass Clinical Research	Audish, Hanid	United States Of America	California	Spring Valley
191	Synexus Clinical Research US, Inc	Bahrami, Ghazaleh	United States Of America	California	Cerritos
192	Clinical Trials ofTexas, Inc	Denham, Douglas	United States Of America	Texas	San Antonio
193	Health Research of Hampton Roads, Inc	Freeman, George	United States Of America	Virginia	Newport News
194	The South Bend Clinic Center for Research	Harris, James	United States Of America	Indiana	South Bend
195	Synexus Clinical Research US, Inc	Nunez, Margarita	United States Of America	New York	Manhattan
196	Clinical Research Institute of Southern Oregon, P.C.	Delgado, John	United States Of America	Oregon	Grants Pass
197	Central Maine Medical Center	Rohr, Kathryn	United States Of America	Maine	Lewiston
198	Healthcare Clinical Data Inc.	Chavoustie, Steven	United States Of America	Florida	North Miami
199	AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company	Noveck, Robert	United States Of America	Louisiana	New Orleans
200	Clinical Research Institute of Southern Oregon, P.C.	Smiley, Sarah	United States Of America	Oregon	Medford
201	eStudySite	Waters, Michael	United States Of America	California	Chula Vista
202	Buynak Clinical Research	Buynak, Robert	United States Of America	Indiana	Valparaiso
203	Velocity Clinical Research, San Diego	Overcash, Jeffrey Scott	United States Of America	California	La Mesa
204	Baptist Health Center for Clinical Research	Wijewardane, Priyantha	United States Of America	Arkansas	Little Rock
205	Sandhill Research	Lefebvre, Gigi	United States Of America	Florida	St. Petersburg
206	Research Your Health	Adelglass, Jeffrey	United States Of America	Texas	Plano
207	Medpharmics, LLC	Atwi, Jibran	United States Of America	Louisiana	Lafayette
208	Tekton Research Inc.	Bell, Robert	United States Of America	Texas	Beaumont
209	Velocity Clinical Research, Inc.	Chang, Margaret	United States Of America	Florida	Edgewater
210	Medisphere Medical Research Center, Llc	Reyes, Hubert	United States Of America	Indiana	Evansville
211	Synexus Clinical Research US, Inc	Pereira, Isabel	United States Of America	California	Vista
212	Tekton Research Inc.	McDonald, Jara	United States Of America	Texas	San Antonio
213	Mercury Street Medical Group, PLLC	Pullman, John	United States Of America	Montana	Butte
214	Tekton Research Inc.	Thakor, Michael	United States Of America	Colorado	Fort Collins
215	Finger Lakes Clinical Research	Whalen, James	United States Of America	New York	Rochester
216	Hope Research Institute	Joshi, Dhiresh	United States Of America	Nevada	Las Vegas
217	Accel Research Sites	Chronos, Nicolas	United States Of America	Georgia	Eatonton
218	Pharmax ResearchClinic Inc	Paez, Henry	United States Of America	Florida	Miami
219	Atlanta Center for Medical Research	Riesenberg, Robert	United States Of America	Georgia	Atlanta
220	Tulane University School of Medicine	Delafontaine, Patrice	United States Of America	Louisiana	New Orleans
221	Clinical Trials of America	Guillory, Clinton	United States Of America	Louisiana	Monroe
222	Monroe Biomedical Research	Igbinadolor, Awawu	United States Of America	North Carolina	Monroe
223	Palm Beach Research Center	Baron, Mira	United States Of America	Florida	West Palm Beach
224	Velocity Clinical Research, Inc.	Erb, David	United States Of America	South Carolina	Gaffney
225	Clinical NeuroScience Solutions, Inc	Dever, Michael	United States Of America	Florida	Orlando
226	Health Awareness inc.	Surowitz, Ronald	United States Of America	Florida	Jupiter
227	American Health Network, LLC	Spangenthal, Selwyn	United States Of America	North Carolina	Charlotte
228	Vilo Research Group Inc	Zepeda, Luis	United States Of America	Texas	Houston
229	University of Louisville	Arnold, Forest	United States Of America	Kentucky	Louisville
230	Wayne State University	Kilgore, Paul	United States Of America	Michigan	Detroit
231	North Texas Infectious Diseases Consultants	Sandkovsky, Uriel	United States Of America	Texas	Dallas
232	Cope Family Medicine- Ogden Clinic	Peterson, Bryce	United States Of America	Utah	Bountiful
233	Richmond Behavioral Associates	DiBuono, Mark	United States Of America	New York	Staten Island
234	Harlem Hospital Center	Mannheimer, Sharon	United States Of America	New York	New York
235	Jefferson City Medical Group Family	Carr, George	United States Of America	Missouri	Jefferson
236	TREAD Research Tygerberg Hospital	Burgess, Lesley	South Africa	Western Cape	Cape Town
237	Josha Research	Lombaard, Johannes	South Africa	Free State	Bloemfontein
238	Newtown Clinical Research	Mitha, Essack	South Africa	Gauteng	Newtown
239	Synexus Watermeyer	Mkhize, Nontokozo	South Africa	Gauteng	Pretoria
240	Tiervlei Trial Centre	Mohamed, Zarinah	South Africa	Western Cape	Cape Town
241	TASK Central	Govender, Thirumani	South Africa	Western Cape	Cape Town
242	Synexus Helderberg Clinical Research Centre	Roux, Susanna	South Africa	Western Cape	Cape Town
243	Stanza Clinical Research Centre : Mamelodi	Kotze, Sheena	South Africa	Gauteng	Mamelodi East
244	DJW Research	Jurgens, Jaco	South Africa	Gauteng	Krugersdorp
245	Allergy Immunology Unit	Peter, Jonathan	South Africa	Western Cape	Cape Town
246	Be Part Yoluntu Centre	Hellstrom, Elizabeth	South Africa	Western Cape	Paarl
247	Madibeng Centre for Research	Louw, Cheryl	South Africa	North West	Brits
248	Paarl Research Centre	Blignaut, Suzanne	South Africa	Western Cape	Paarl
249	The Aurum Institute Rustenburg Clinical Research Site	Brumskine, William	South Africa	North West	Rustenburg
250	Iatros International	Fourie, Nyda	South Africa	Free State	Bloemfontein
251	Worthwhile Clinical trials	Hussen, Nazreen	South Africa	Gauteng	Johannesburg
252	REIMED Vosloorus	Mabale, Primrose	South Africa	Gauteng	Vosloorus
253	CRISMO Bertha Gxowa Research Centre	Mamba, Musawenkosi	South Africa	Gauteng	Johannesburg
254	TASK Central	Snyman, Elizma	South Africa	Western Cape	George
255	Global Clin Trials Pretoria	Pillay Ramaya, Larisha	South Africa	Gauteng	Pretoria
256	Clinresco Centres Pty Ltd	Rosa, Jennifer	South Africa	Gauteng	Johannesburg
257	Welkom Clinical Trial Centre	Wilhase, Agatha	South Africa	Free State	Welkom
258	射阳县疾病预防控制中心	朱凤才	中国	江苏省	盐城市
259	阜宁县疾病预防控制中心	朱凤才	中国	江苏省	盐城市
260	滨海县疾病预防控制中心	朱凤才	中国	江苏省	盐城市
261	邳州市疾病预防控制中心	朱凤才	中国	江苏省	徐州市
262	新沂市疾病预防控制中心	朱凤才	中国	江苏省	徐州市
263	东海县疾病预防控制中心	朱凤才	中国	江苏省	连云港市

序号	名称	审查结论	批准日期/备案日期
1	江苏省疾病预防控制中心伦理审查委员会	同意	2022-04-29

进行中（尚未招募）

目标入组人数	国内: 3600 ； 国际: 23000 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；
实际入组总人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；

第一例受试者签署知情同意书日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
试验完成日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；