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A Maternal Short Course of Tenofovir Disoproxil Fumarate and Infant Vaccine to Prevent Mother-To-Child Transmission of Hepatitis B Virus

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A Maternal Short Course of Tenofovir Disoproxil Fumarate and Infant Vaccine to Prevent Mother-To-Child Transmission of Hepatitis B Virus Study Title: Antiviral prophylaxis and infant vaccination to prevent perinatal hepatitis B infection, version 1.0 dated 21 August 2017 Protocol A Maternal Short Course of Tenofovir Disoproxil Fumarate and Infant Vaccine to Prevent Mother-to-Child Transmission of Hepatitis B Virus Short title: Antiviral prophylaxis and infant vaccination to prevent perinatal hepatitis B infection Version 1.0 August 21 , 2017 Study Coordination Center: PHPT (Chiang Mai University - Institut de recherche pour Ie development Collaboration) 110 Intawaroros Rd. T. Sripoom, Muang OJ. Chiang Mai 50200 , Thailand ') , O! C:?.:' r '\ Telephone: +66 5381 9125 (up to 29) 2 1 ~ . O . ~ 2 r, 6 0 Fax: +66 53252253, +66 5381 9130 , I ..J E-mail: gon [email protected] t) · :; m :i 1J n 1.j ~lV 1i H l1 f1l 1 1 ~tJ hnJ .lI ~ tJ (~ll ,rlH~~;.r"JlFn" ~" ...x-e- -, •.,- -j ~ ' r " ':C ' ~ " lJ ~ :" • .r-« I J "J ~ " " 'it}JrJ (lYflL , Study Title: Antiviral prophylaxis and infant vaccination to prevent perinatal hepatitis 8 infection, version 1.0 dated 21 August 2017 Table of Contents 1. Study Title 4 2. Protocol team and investigators' names and contact information .4 3. Project Summary 10 4. Background information 12 4.1 Background 12 4.2 Study Rationale 14 5. Study specific objectives 15 5.1 Study objectives 15 5.2 Study Design 16 6. Study sites and duration of the study 17 6.1 Study sites 17 6.2 Duration of the study 18 7. Workplan 19 7.1 Study population 19 7.1.1 Eligibility 19 7.1.2 Inclusion criteria 19 7.1.3 Exclusion criteria 19 7.1.4 Discontinuation criteria 19 7.2 Implementation, data collection, and monitoring procedures 20 7.2.1 Follow-up and study procedures 20 7.2.2 Laboratory assessments 22 7.2.3 Data collection 22 7.2.4 Reporting 22 7.2.5 Study implementation onsite monitoring 23 7.3 Study drugs 23 7.4 Biohazard Containment 23 7.5 Statistical considerations 23 7.5.1 Justifications for the design 23 7.5.2 Endpoints 23 7.5.3 Sample size 24 7.5.4 Analyses for the primary objective 25 7.5.5 Analyses for the secondary objectives/endpoints 25 7.6 Data and Safety Monitoring Board 26 8. Ethical considerations 26 8.1 Potential Risks to Participants 26 8.1 .1 Maternal risks associated with the use of tenofovir disoproxil fumarate (TDF) during pregnancy 27 8.1.2 Infant risks associated with the lack of HBlg administration 27 8.1.3 Infant risks associated with in utero exposure to tenofovir 28 8.2 Adequacy of Protection Against Risks 28 _ a: , ) ~ r ..... , ' :; Page 2 of 34 2 1r? EJ. 2560 fl ':::n111Jnu ~1(Jti1 ·nJrn'1~tl' U1Jllll ~Ol,j nh'l.:l 111if~t1·HHfll11~VtU1J'4l1fl(['I'm Study Title: Antiviral prophylaxis and infant vaccination to prevent perinatal hepatitis B infection . version 1,0 dated 21 August 2017 8.2.1 Recruitment and informed consent 28 8.2.2 Protection against risk 29 8.3 Potential Benefits of the Proposed Research to the Participants and Others 29 8.3.1 Mothers 29 8.3.2 Expected infant close contacts 29 8.3.3 Infants 30 8.4 Importance of the knowledge to be gained 30 9. References 31 Appendix 1: Cockcroft-Gault formula for women 34 2 1-'fr o.D, 2560 l'l . 'z rn11J0lIU1{J!iI 'HJn l i 1 oij'v1lUJl.jlJO Page 3 of 34 Study Title: Antiviral prophylaxis and infant vaccination to prevent perinatal hepatitis B infection, version 1.0 dated 21 August 2017 1. Study Title A maternal short course of tenofovir disoproxil fumarate and infant vaccine to prevent mother-to-child transmission of hepatitis B virus Short title: Antiviral prophylaxis and infant vaccination to prevent perinatal hepatitis B infection 2. Protocol team and investigators' names and contact information Leaders: Gonzague Jourda in, MD, PhD (Principal Suchada Jiams iri, MD, MPH Investigator) Viral Hepatitis Unit PHPT -IRD UMI174 Department of Disease Control, Ministry of Faculty of Associated Medical Sciences Public Health, Thailand Chiang Mai University 88/21 Tiwanon Rd. Talard-Kwan , 110 Intawaroros Rd., T. Sripoom , Muang , Nonthaburi 11000 Chiang Mai 50200 Tel: +6625903000 Tel: +665381 9125 - Fax: +665381 9130 Email: [email protected]. Email: [email protected] [email protected] [email protected] Team: other members Nicole Ngo-Giang-Huong, PharmD, PhD Tim Roy Cressey, PhD PHPT -IRD UMI174 PHPT -IRD UMI174 Faculty of Associated Medical Sciences Faculty of Associated Medical Sciences Chiang Mai University Chiang Mai University 110 Intawaroros Rd. T. Sripoom , Muang, 110 Intawaroros Rd. T. Sripoom, Muang , Chiang Mai 50200 Chiang Mai 50200 Tel: +66 5381 9125- Fax: +66 5381 9130 Tel: +66 5381 9125 - Fax: +66 5381 9130 Email: [email protected] . Email: [email protected] Nicolas Salvadori, MSc Vatthanaphone Latthaphasavang, MD PHPT -IRD UMI174 Pediatrics Department Faculty of Associated Medical Sciences Infectious Diseases Center Chiang Mai University Mahosot Hospital, Kaognot Village , 110 Intawaroros Rd. T. Sripoom , Muang , Vientiane Capital , Lao PDR Chiang Mai 50200 Tel: +856 20 55526189 Tel: +66 5381 9125 - Fax: +66 5381 9130 Email:[email protected] Email: [email protected] Woottichai Khamduang, PhD Camlin Tierney, PhD Faculty of Associated Medical Sciences Harvard School of Public Health Chiang Mai University Center for Biostatistics in AIDS Research 110 Intawaroros Rd. T. Sripoom, Muang, FXB Building 514 Chiang Mai 50200 651 Huntington Ave Tel: +665381 9125Fax: +66 5381 9130 Boston, MA 02115 , USA Email: [email protected] Tel: +1 6174320547 Email: [email protected] Kanawee Thetket, MD Wasna Sirirungsi, PhD Nakornping Hospital Faculty of Associated Medical Sciences Department of Internal Medicine Chiang Mai University 159 M.10 Chotana Rd., T. Don Keaw, 110 Intawaroros Rd. T. Sripoom, Muang, Mae Rim, Chiang Mai 50180 Chiang Mai 50200 Tel: +6653999200 - Fax: +66 5322 2152 Tel: +6653945063 Fax: +6653946042 Email: [email protected] Email: wasna.s@cm l!: ~c; Ih4 ,.,. _,.,.....~ Page 4 of 34 Yl~ .r~~ o Study Title: Antiviral prophylaxis and infant vaccination to prevent perinatal hepatitis B infection, version 1.0 dated 21 August 2017 Thanyawee Puthanakit, MD Sombat Thanprasertsuk, MD, MPH King Chulalongkorn Memorial Hospital Department of Disease Control Chulalongkorn University Ministry of Public Health Phayathai Road, Wangmai , Pathum Wan, Tivanont Road, Muang, Bangkok 10330 Nonthaburi 11000, Thailand Tel: +66 2 256 4000 Tel: +6625903201 - Fax: +662591 8413 Email: [email protected] Email: stpss@health .moph.go.th Raymond T. Chung, MD Stanislas Pol, MD, PhD Massachusetts General Hospital Department of Hepato-Gastroenterology, Cochin Gastrointestinal Unit University Hospital, 55 Fruit St 27 rue du Faubourg Saint-Jacques, 75679 Paris Boston, MA 02114, USA Cedex 14, France Tel: +1 617/724-7562 - Fax: +1 617/643-0446 Tel: +33 1 5841 1955 Email: [email protected] Email: [email protected] Co-investigators at participating sites Thailand Health Promotion Center Region 1 Health Promotion Center Region 1 Suraphan Sangsawang, MD Chotiros Phanpong, MD Obstetrics & Gynecology Department Pediatrics Department 51 Prachasumphan Rd., T. Changklan, Muang, 51 Prachasumphan Rd., T. Changklan , Muang, Chiang Mai 50100 Chiang Mai 50100 Tel: +66 5327 2740 - Fax: +6653274015 ext 119 Tel: +6653272740 - Fax: +6653274015 ext 119 Email: [email protected] Email: [email protected] Lamphun Hospital Lamphun Hospital Wanmanee Matanasarawut, MD Rosalin Somsamai, MD Obstetrics & Gynecology Department Pediatrics Department 177 Sai Rim Ping Rd., T. Tonthong, Muang, 177 Sai Rim Ping Rd., T. Tonthong, Muang, Lamphun 51000 Lamphun 51000 Tel: +6653569100 ext 2150 - Fax: +66 5356 9123 Tel: +6653569100 - Fax: +6653569123 Email: obQyn [email protected] Email: Ross [email protected] Phayao Hospital Phayao Hospital Pornnapa Suriyachai, MD Pannarai Nasomchai, MD Obstetrics & Gynecology Department Pediatrics Department 269 Phaholyothin Rd., T. Tom, Muang, 269 Phaholyothin Rd., T. Tom, Muang, Phayao 56000 Phayao 56000 Tel: +66 5443 1209 - Fax: +66 5440 9330 Tel: +665443 1169 - Fax: +66 5448 1708 Email: whan76 [email protected] Email: [email protected] Chiangrai Prachanukroh Hospital Chiangrai Prachanukroh Hospital Jullapong Achalapong, MD Chulapong Chanta, MD Obstetrics & Gynecology Department Pediatrics Department 1039 Sathanpayaban Rd., T. Wiang, Muang 1039 Sathanpayaban Rd., T. Wiang , Muang, Chiang Rai 57000 Chiang Rai 57000 Tel: +66 5371 1300 ext 1217 - Fax: +66 5371 3044 Tel: +66 5371 1300 ext 1274 - Fax: +66 5371 3044 Email:[email protected] Email: Chul [email protected] Chiang Kharn Hospital Mae Sai Hospital Chaiwat Putiyanun, MD Jariyarat Nitipipatl<osol, MD Obstetrics & Gynecology Department Pediatrics Department 244 M.4 T. Yuan, Chiang Kham, 101 M.10 T. Wiangbangkham, Mae Sai Phayao 56110 Chiang Rai 57130 Tel: +6654451300-1 - Fax: +6654416615 Tel: +6653731 301, +66 53 642 510 ext 2345 Email: [email protected] Email: cookie.aom@hotmaiJ:co.m f)l!~~ Page 5 of 34 2 1 ,0. 2560 fit :: r1771Jnl:iiJ7fJ1i HllfJU=)ljuhnJ'\.JlHI Study Titl e: Antiviral prophylaxis and infant vaccination 10prevent perinatal hepatitis B infection, version 1.0 dated 21 August 2017 Mae Chan Hospital Rayong Hospital Iyara Wongpia, MD Supoj Wattanasiri, MD Obstetrics & Gynecology Departme nt Obstetrics & Gynecology Department 274 M.5 Phaholyothin Rd., T. Mae Cha n, Mae 138 Sukumvith Rd. T.Thapradoo, Muang Chan, Chiangrai 57110 Rayong 21000 Tel : +665377 1056 - Fax: + 66 5366 0961 Tel: +66 38 611 104 - Fax: +66 38 612 003 Email: [email protected] Email: [email protected] Prapokklao Hospital Prapokklao Hospital Sirida Kositchaiwat , MD Kanokkorn Swasdichai , MD Obstetrics & Gyneco logy Depa rtment Pediatrics Depa rtment 38 Leibnern Rd., Muang 38 Leibnern Rd., Muang Chantaburi 22000 Cha ntaburi 22000 Tel : +66 39 324975 ext. 5253 - Fax: +66 3931 1511 Tel : +66 3932 4975 ext. 5253 Email : [email protected] Fax: +663931 1511 Banglamung Hospital Banglamung Hospital Prateep Kanja navikai, MD Siriluk Phanomcheong, MD Obstetrics & Gynecology Department Pediatrics Depa rtmen t 669 M.5 Phattaya-Naklua T.
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