Safety and immunogenicity of conjugate vaccine for typhoid (Vi-DT): Finding from an observer-blind, active-controlled, randomized, non-inferiority, phase III clinical trial among healthy volunteers

Authors: Dipesh Tamrakar, Pranodan Poudel, Pragya Thapa, Srijana Singh, Amit Khadgi, Sameera Thapa, Rajendra Tamrakar, Anmol Shrestha, Surendra Madhup, Ganesh Kumar Rai, Birendra Prasad Gupta, Tarun Saluja, Sushant Sahastrabuddhe, Rajeev Shrestha

Source: Human Vaccines & Immunotherapeutics, Vol 20, Iss 1 (2024)

Subject Terms: Typhoid, conjugate vaccine, observer-blind, randomized, phase III clinical trial, Immunologic diseases. Allergy, RC581-607, Therapeutics. Pharmacology, RM1-950

File Description: electronic resource

Relation: https://doaj.org/toc/2164-5515; https://doaj.org/toc/2164-554X

Access URL: https://doaj.org/article/028ffd7dcc0941d38c9bd4388f3e04de

Biases in COVID-19 vaccine effectiveness studies using cohort design

Authors: Suneth Agampodi, Birkneh Tilahun Tadesse, Sushant Sahastrabuddhe, Jean-Louis Excler, Jerome Han Kim

Source: Frontiers in Medicine, Vol 11 (2024)

Subject Terms: COVID-19, vaccine effectiveness, cohort studies, biases, misclassification bias, healthy user bias, Medicine (General), R5-920

File Description: electronic resource

Relation: https://www.frontiersin.org/articles/10.3389/fmed.2024.1474045/full; https://doaj.org/toc/2296-858X

Access URL: https://doaj.org/article/ac556ae118754b7fa59d2fddf6472896

The Selangor Consensus: strengthening clinical trials for local public health in the Western Pacific

Authors: Kidong Park, Mengji Chen, Jinho Shin, Gui Xian Ong, Vasee Moorthy, Wei Zhang, Bin Cao, Chia Wei Phan, Chun Keat Chew, Fiona Russell, Ganzorig Dorjdagva, Hani Kim, Hitomi Sumiyoshi Okuma, Hyun-Young Park, Iris Conela Tagaro, Jing Li, Jungyeon Kim, Justin Im, Koji Wada, Koukeo Phommasone, Li Yang Hsu, Philip Rajan Devesahayam, Robyn Whittaker, Saiful Safuan Md Sani, Sheamini Sivasampu, Sushant Sahastrabuddhe, Vonthanak Saphonn, Yin Mo, Zaril Harza Zakaria

Source: The Lancet Regional Health. Western Pacific, Vol 48, Iss , Pp 101136- (2024)

Subject Terms: Public aspects of medicine, RA1-1270

File Description: electronic resource

Relation: http://www.sciencedirect.com/science/article/pii/S2666606524001305; https://doaj.org/toc/2666-6065

Access URL: https://doaj.org/article/b0e32b275b0f4ca0aeceb40f9e70285e

A phase II clinical trial of a Vi-DT typhoid conjugate vaccine in healthy Indonesian adolescents and adults: one-month evaluation of safety and immunogenicity

Authors: Sukamto Koesnoe, Bernie Endyarni Medise, Iris Rengganis, Sri Rezeki Hadinegoro, Mita Puspita, Rini Mulia Sari, Jae Seung Yang, Sushant Sahastrabuddhe, Soedjatmiko, Hartono Gunardi, Rini Sekartini, Angga Wirahmadi, Aria Kekalih, Sreshta Mukhi, Hindra Irawan Satari, Novilia Sjafri Bachtiar

Source: Tropical Diseases, Travel Medicine and Vaccines, Vol 10, Iss 1, Pp 1-6 (2024)

Subject Terms: Typhoid Fever, Typhoid conjugate vaccine, Vi-DT, Vi-PS, Arctic medicine. Tropical medicine, RC955-962

File Description: electronic resource

Relation: https://doaj.org/toc/2055-0936

Access URL: https://doaj.org/article/5ec1d44fdd4c49cdafd61cd2e632801e

Programmatic considerations and evidence gaps for chikungunya vaccine introduction in countries at risk of chikungunya outbreaks: Stakeholder analysis.

Authors: Megan Auzenbergs, Clara Maure, Hyolim Kang, Andrew Clark, Oliver Brady, Sushant Sahastrabuddhe, Kaja Abbas

Source: PLoS Neglected Tropical Diseases, Vol 18, Iss 4, p e0012075 (2024)

Subject Terms: Arctic medicine. Tropical medicine, RC955-962, Public aspects of medicine, RA1-1270

File Description: electronic resource

Relation: https://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0012075&type=printable; https://doaj.org/toc/1935-2727; https://doaj.org/toc/1935-2735

Access URL: https://doaj.org/article/f52c4f3a997a4cc0af7f0baa8cea57e7

Immunogenicity and safety of SARS-CoV-2 recombinant protein nanoparticle vaccine GBP510 adjuvanted with AS03: interim results of a randomised, active-controlled, observer-blinded, phase 3 trialResearch in context

Authors: Joon Young Song, Won Suk Choi, Jung Yeon Heo, Eun Jin Kim, Jin Soo Lee, Dong Sik Jung, Shin-Woo Kim, Kyung-Hwa Park, Joong Sik Eom, Su Jin Jeong, Jacob Lee, Ki Tae Kwon, Hee Jung Choi, Jang Wook Sohn, Young Keun Kim, Byung Wook Yoo, In-Jin Jang, Maria Z. Capeding, François Roman, Thomas Breuer, Piotr Wysocki, Lauren Carter, Sushant Sahastrabuddhe, Manki Song, Naveena D'Cor, Hun Kim, Ji Hwa Ryu, Su Jeen Lee, Yong Wook Park, Hee Jin Cheong, Agathe Philippot, Francesca Solmi, Maria Angeles Ceregido, Byoung-Shik Shim, Sang Hwan Seo, Simone D'Souza, Patchara Thaisrivichai, Josefina Carlos, Edison Alberto, Sorachai Nitayaphan, Winai Ratanasuwan, Piroon Mootsikapun, Romanee Chaiwarith, Luong Chan Quang, Olena Karpenko, Tatiana Yurkiv, Vitalii Kutovyi, Angela Bartko, Olga Gyrina, Olga Barna, Mykhailo Pugach, Claire Thurlow, Simon Carson, Susan Smith, Mike Williams, Tiwini Hemi Senior, Tim Humphrey, Davitt Sheahan, Hokeun Park, Yoon Yeong Lee, Seung Gu Kang

Source: EClinicalMedicine, Vol 64, Iss , Pp 102140- (2023)

Subject Terms: SARS-CoV-2, COVID-19, Recombinant protein vaccine, Nanoparticle vaccine, Immunogenicity, Safety, Medicine (General), R5-920

File Description: electronic resource

Relation: http://www.sciencedirect.com/science/article/pii/S2589537023003176; https://doaj.org/toc/2589-5370

Access URL: https://doaj.org/article/608a2ee1e423411eb689bce93946af34

Immune persistence and response to booster dose of Vi-DT vaccine at 27.5 months post-first dose

Authors: Maria Rosario Capeding, Birkneh Tilahun Tadesse, Arijit Sil, Edison Alberto, Deok Ryun Kim, Eun Lyeong Park, Ju Yeon Park, Jae Seung Yang, Jagadeesh Reddy Eluru, Sue-Kyoung Jo, Hun Kim, Seon-Young Yang, Ji Hwa Ryu, Hokeun Park, Jong Hoon Shin, Yoonyeong Lee, Jerome H. Kim, Zenaida Reynoso Mojares, T. Anh Wartel, Sushant Sahastrabuddhe

Source: npj Vaccines, Vol 7, Iss 1, Pp 1-8 (2022)

Subject Terms: Immunologic diseases. Allergy, RC581-607, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282

File Description: electronic resource

Relation: https://doaj.org/toc/2059-0105

Access URL: https://doaj.org/article/e37d05b1c20b4f23851267351eb19f82

A randomized, observer-blind, controlled phase III clinical trial assessing safety and immunological non-inferiority of Vi-diphtheria toxoid versus Vi-tetanus toxoid typhoid conjugate vaccine in healthy volunteers in eastern Nepal

Authors: Shipra Chaudhary, Gauri Shankar Shah, Nisha Keshary Bhatta, Prakash Poudel, Basant Rai, Surendra Uranw, Prashant Mani Tripathi, Basudha Khanal, Anup Ghimire, Nikita Rai, Birendra Prasad Gupta, Sridhar Vemula, T. Anh Wartel, Sushant Sahastrabuddhe, Tarun Saluja

Source: Human Vaccines & Immunotherapeutics, Vol 19, Iss 1 (2023)

Subject Terms: typhoid conjugate vaccine, vi-dt, safety, immunogenicity, immune non-inferiority, eastern nepal, Immunologic diseases. Allergy, RC581-607, Therapeutics. Pharmacology, RM1-950

File Description: electronic resource

Relation: https://doaj.org/toc/2164-5515; https://doaj.org/toc/2164-554X

Access URL: https://doaj.org/article/a37c74248a6843bda9ab2fee36f237c5

Factors affecting willingness to participate in vaccine clinical trials in an underdeveloped country: perspective from Nepal

Authors: Ram Hari Chapagain, Santosh Adhikari, Bishnu Rath Giri, Pankaj Ray, Nisha Jyoti Shrestha, Bina Prajapati, Prakash Joshi, Sunita Pokharel, Suresh Man Tamang, Birendra Prasad Gupta, T. Anh Wartel, Sushant Sahastrabuddhe, Ganesh Kumar Rai, Tarun Saluja

Source: Human Vaccines & Immunotherapeutics, Vol 18, Iss 5 (2022)

Subject Terms: clinical trial, factors, informed consent, participation, willingness, Immunologic diseases. Allergy, RC581-607, Therapeutics. Pharmacology, RM1-950

File Description: electronic resource

Relation: https://doaj.org/toc/2164-5515; https://doaj.org/toc/2164-554X

Access URL: https://doaj.org/article/7a792ba27cd54d2884631e771e93f142

Challenges and opportunities in setting up a phase III vaccine clinical trial in resource limited settings: Experience from Nepal

Authors: Tarun Saluja, Bishnu Rath Giri, Shipra Chaudhary, Dipesh Tamrakar, Piush Kanodia, Sonali Palkar, Sridhar Vemula, Suchada Chinaworapong, Bomi Kim, Birendra Prasad Gupta, Sue Kyoung Jo, Sanet Aspinall, Ganesh Kumar Rai, Duncan Steele, Jerome H. Kim, T. Anh Wartel, Sushant Sahastrabuddhe

Source: Human Vaccines & Immunotherapeutics, Vol 17, Iss 7, Pp 2149-2157 (2021)

Subject Terms: capacity building, resource-limited settings, phase iii, vaccine trial, clinical trial, Immunologic diseases. Allergy, RC581-607, Therapeutics. Pharmacology, RM1-950

File Description: electronic resource

Relation: https://doaj.org/toc/2164-5515; https://doaj.org/toc/2164-554X

Access URL: https://doaj.org/article/e12334ef5c8b46b391245a371de2d894

A Phase 3, Multicenter, Randomized, Controlled Trial to Evaluate Immune Equivalence and Safety of Multidose and Single-dose Formulations of Vi-DT Typhoid Conjugate Vaccine in Healthy Filipino Individuals 6 Months to 45 Years of Age

Authors: Josefina Cadorna Carlos, Birkneh Tilahun Tadesse, Charissa Borja-Tabora, Edison Alberto, Michelle C. Ylade, Arijit Sil, Deok Ryun Kim, Hyeon Seon Ahn, Jae Seung Yang, Ji Yeon Lee, Min Soo Kim, Jiwook Park, Soo-Young Kwon, Hun Kim, Seon-Young Yang, Ji-hwa Ryu, Hokeun Park, Jong-hoon Shin, Yoonyeong Lee, Jerome H. Kim, Zenaida Reynoso Mojares, T. Anh Wartel, Sushant Sahastrabuddhe

Source: The Lancet Regional Health. Western Pacific, Vol 24, Iss , Pp 100484- (2022)

Subject Terms: Typhoid fever, Vi-DT vaccine, Immune equivalence, Single dose formulation, Multidose formulation, Public aspects of medicine, RA1-1270

File Description: electronic resource

Relation: http://www.sciencedirect.com/science/article/pii/S2666606522000992; https://doaj.org/toc/2666-6065

Access URL: https://doaj.org/article/c3a9e8c4d0bd42cf8e67b9d30d0b9118

A novel Vi-diphtheria toxoid typhoid conjugate vaccine is safe and can induce immunogenicity in healthy Indonesian children 2–11 years: a phase II preliminary report

Authors: Bernie Endyarni Medise, Soedjatmiko Soedjatmiko, Hartono Gunardi, Rini Sekartini, Hindra Irawan Satari, Sri Rezeki Hadinegoro, Angga Wirahmadi, Mita Puspita, Rini Mulia Sari, Jae Seung Yang, Arijit Sil, Sushant Sahastrabuddhe, Novilia Sjafri Bachtiar

Source: BMC Pediatrics, Vol 20, Iss 1, Pp 1-8 (2020)

Subject Terms: Immunogenicity, Safety, Typhoid conjugate vaccine, Vi-DT vaccine, Vi-PS vaccine, Pediatrics, RJ1-570

File Description: electronic resource

Relation: http://link.springer.com/article/10.1186/s12887-020-02375-4; https://doaj.org/toc/1471-2431

Access URL: https://doaj.org/article/f8fea140698d4438b598aad2c5840bea

One-month follow up of a randomized clinical trial-phase II study in 6 to

Authors: Bernie Endyarni Medise, Soedjatmiko Soedjatmiko, Hartono Gunardi, Rini Sekartini, Hindra Irawan Satari, Sri Rezeki Hadinegoro, Angga Wirahmadi, Mita Puspita, Rini Mulia Sari, Jae Seung Yang, Arijit Sil, Sushant Sahastrabuddhe, Novilia Sjafri Bachtiar

Source: International Journal of Infectious Diseases, Vol 93, Iss , Pp 102-107 (2020)

Subject Terms: Infectious and parasitic diseases, RC109-216

File Description: electronic resource

Relation: http://www.sciencedirect.com/science/article/pii/S1201971220300485; https://doaj.org/toc/1201-9712

Access URL: https://doaj.org/article/cc142caad7924048913656a2cd3aff03

Safety and Protective Effects of Influenza Vaccination in Pregnant Women on Pregnancy and Birth Outcomes in Pune, India: A Cross-Sectional Study

Authors: Hanif Shaikh, Pranesha Koli, Vaishali Undale, Anil Pardeshi, Mahesh Asalkar, Sushant Sahastrabuddhe, Anand Kawade, Chandrashekhar Upasani

Source: Vaccines, Vol 11, Iss 6, p 1034 (2023)

Subject Terms: maternal immunization, influenza vaccination, pregnant women, pregnancy outcome, Medicine

File Description: electronic resource

Relation: https://www.mdpi.com/2076-393X/11/6/1034; https://doaj.org/toc/2076-393X

Access URL: https://doaj.org/article/ce32d9b247ca4a10bd8c04bac6776a78

Mapping the high burden areas of cholera in Nepal for potential use of oral cholera vaccine: An analysis of data from publications and routine surveillance systems

Authors: Chulwoo Rhee, Birendra Prasad Gupta, Bibek Kumar Lal, Jacqueline Kyungah Lim, T Anh Wartel, Julia Lynch, Sushant Sahastrabuddhe

Source: Asian Pacific Journal of Tropical Medicine, Vol 13, Iss 3, Pp 107-114 (2020)

Subject Terms: cholera, outbreak, oral cholera vaccine, surveillance, nepal, Arctic medicine. Tropical medicine, RC955-962

File Description: electronic resource

Relation: http://www.apjtm.org/article.asp?issn=1995-7645;year=2020;volume=13;issue=3;spage=107;epage=114;aulast=Rhee; https://doaj.org/toc/2352-4146

Access URL: https://doaj.org/article/4d6a3223316d4610a417e57a0d16d6c0

Safety and immunogenicity of Vi-DT conjugate vaccine among 6-23-month-old children: Phase II, randomized, dose-scheduling, observer-blind Study

Authors: Maria Rosario Capeding, Arijit Sil, Birkneh Tilahun Tadesse, Tarun Saluja, Samuel Teshome, Edison Alberto, Deok Ryun Kim, Eun Lyeong Park, Ju Yeon Park, Jae Seung Yang, Suchada Chinaworapong, Jiwook Park, Sue-Kyoung Jo, Yun Chon, Seon-Young Yang, Ji Hwa Ryu, Inho Cheong, Kyu-Young Shim, Yoonyeong Lee, Hun Kim, Julia A. Lynch, Jerome H. Kim, Jean-Louis Excler, T. Anh Wartel, Sushant Sahastrabuddhe

Source: EClinicalMedicine, Vol 27, Iss , Pp 100540- (2020)

Subject Terms: Infants and toddlers, Typhoid, typhoid conjugate vaccine, Vi-DT, Medicine (General), R5-920

File Description: electronic resource

Relation: http://www.sciencedirect.com/science/article/pii/S2589537020302844; https://doaj.org/toc/2589-5370

Access URL: https://doaj.org/article/aced71a85bf64c20b114d96beda3a6aa

Comparison of anti-Vi IgG responses between two clinical studies of typhoid Vi conjugate vaccines (Vi-DT vs Vi-TT).

Authors: Eun Young Lee, Ju Yeon Park, Deok Ryun Kim, Manki Song, Sushant Sahastrabuddhe, Hun Kim, Yun Chon, Jae Seung Yang

Source: PLoS Neglected Tropical Diseases, Vol 14, Iss 3, p e0008171 (2020)

Subject Terms: Arctic medicine. Tropical medicine, RC955-962, Public aspects of medicine, RA1-1270

File Description: electronic resource

Relation: https://doaj.org/toc/1935-2727; https://doaj.org/toc/1935-2735

Access URL: https://doaj.org/article/8bddc18ad7454b44bb381945ab58d7c5

Progress and challenges in Nipah vaccine development and licensure for epidemic preparedness and response

Authors: Sol Kim, Hyolim Kang, Laura Skrip, Sushant Sahastrabuddhe, Ausraful Islam, Sung-Mok Jung, Juan F. Vesga, Akira Endo, W. John Edmunds, Kaja Abbas

Source: Expert Review of Vaccines, Vol 24, Iss 1, Pp 183-193 (2025)

Subject Terms: Alternative regulatory pathway, Nipah virus, Henipavirus nipahense, pandemic preparedness, vaccine efficacy trials, vaccine licensure, Internal medicine, RC31-1245

File Description: electronic resource

Relation: https://doaj.org/toc/1476-0584; https://doaj.org/toc/1744-8395

Access URL: https://doaj.org/article/83ea1e1c8ac04b088f95babd25a39857

Six-month follow up of a randomized clinical trial-phase I study in Indonesian adults and children: Safety and immunogenicity of Salmonella typhi polysaccharide-diphtheria toxoid (Vi-DT) conjugate vaccine.

Authors: Bernie Endyarni Medise, Soedjatmiko Soedjatmiko, Iris Rengganis, Hartono Gunardi, Rini Sekartini, Sukamto Koesno, Hindra Irawan Satari, Sri Rezeki Hadinegoro, Jae Seung Yang, Jean-Louis Excler, Sushant Sahastrabuddhe, Mita Puspita, Rini Mulia Sari, Novilia Sjafri Bachtiar

Source: PLoS ONE, Vol 14, Iss 2, p e0211784 (2019)

Subject Terms: Medicine, Science

File Description: electronic resource

Relation: https://doaj.org/toc/1932-6203

Access URL: https://doaj.org/article/d17812f2660d495390774f5269a1ed41

The long-term impact of vaccine clinical research on national stakeholders involved: Experience from a low-income Country

Authors: Rejwana Haque Pial, Ganesh Kumar Rai, Rajeev Shrestha, Santa Kumar Das, Ram Hari Chapagain, Shipra Chaudhary, Dipesh Tamrakar, Piush Kanodia, Pragya Thapa, Sridhar Vemula, Birendra Prasad Gupta, Alexandra Hill, Derick Kimathi, Rita Baiden, Hee Soo Kim, Jean-Louis Excler, T. Anh Wartel, Sushant Sahastrabuddhe, Tarun Saluja

Source: Human Vaccines & Immunotherapeutics, Vol 21, Iss 1 (2025)

Subject Terms: LMICs, clinical trials, vaccines, capacity building, infrastructure, health systems, Immunologic diseases. Allergy, RC581-607, Therapeutics. Pharmacology, RM1-950

File Description: electronic resource

Relation: https://doaj.org/toc/2164-5515; https://doaj.org/toc/2164-554X

Access URL: https://doaj.org/article/207bfc0d6c2445878e5a1003b460d1bc