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1. Safety and immunogenicity of the Euvichol-S oral cholera vaccine for prevention of Vibrio cholerae O1 infection in Nepal: an observer-blind, active-controlled, randomised, non-inferiority, phase 3 trial

Author

Song, Katerina Rok, Chapagain, Ram Hari, Tamrakar, Dipesh, Shrestha, Rajeev, Kanodia, Piush, Chaudhary, Shipra, Wartel, T Anh, Yang, Jae Seung, Kim, Deok Ryun, Lee, Jinae, Park, Eun Lyeong, Cho, Haeun, Lee, Jiyoung, Thaisrivichai, Patchara, Vemula, Sridhar, Kim, Bo Mi, Gupta, Birendra, Saluja, Tarun, Pansuriya, Ruchir Kumar, Ganapathy, Ravi, Baik, Yeong Ok, Lee, Young Jin, Jeon, Suhi, Park, Youngran, Her, Howard L, Park, Youngshin, and Lynch, Julia A

Published
2024
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2. Efficacy of a monovalent (D614) SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant in adults: a phase 3, multi-country study

Author

Abalos, Karina, Adams, Michael, Allaw, Mohamed, Aloysia, Naveena, Amuasi, John Humphrey, Ansah, Nana Akosua, Asante, Kwaku Poku, Benkeser, David, Berge, Aude, Breuer, Thomas, Briesemeister, Liz, Broder, Gail, Bonfanti, Alberto Cadena, Calinescu, Cornell, Canter, Richard, Carrillo, Jaime Augusto, Chansinghakul, Danaya, Coux, Florence, Das, Chandan, Davies, Matthew, Devlin, Louis, Fay, Michael, Follmann, Dean, Frago, Carina, Fukase, Hiroyuki, Garinga, Agnes, Gilbert, Peter B., Gonzalez, Claudia, Granados, Maria Angelica, Greiwe, Cathy, Guillery, Lea, Hall, Jessicalee, Henderson, Jeffrey, Huang, Ying, Hudzina, Kathy, Hural, John, Hutchens, Mark, Jain, Manish, Jennings, William, Kanodia, Piush, Kimmel, Murray, Kirby, William, Khandelwal, Nitin, Kopp, James, Kosolsak, Chalit, Kublin, Jim, Kukian, Darshna, Kushwaha, Jitendra Singh, Laot, Thelma, Lopez-Medina, Eduardo, Arroyo, Hugo Macareno, Mamod, Stephanie, Mangarule, Somnath, Martin, Troy, Menard, Lisa, Mendoza, Sandra, Meyer, Robert, Middleton, Randle, Miracle, Jill, Mizuyama, Kazuyuki, Mohapatra, Satyajit, Moreau, Catherine, Murray, Linda, Nagamatsu, Shinya, Newberg, Joseph, Noriega, Fernando, Nugent, Paul, Peake-Andrasik, Michele, Pekala, David, Peng, Penny, Py, Marie-Laure, Ramirez, Shelly, Reddy, Chinthaparthi Prabhakar, Reynolds, Michelle, Rivas, Enrique, Sater, Nessryne, Shah, Jinen, Sher, Lawrence, Sieger, Silva, Singh, Chandramani, Singh, Veer Bahadur, Sirisuphmitr, Nuchra, Starkey, Thomas, Suzuki, Kazuo, Tamrakar, Dipesh, Tangemen, Cayce, Da-Silva, Fernanda Tavares, Taylor, David, Tharenos, Leslie, Wartel, T. Anh, Zaworski, Elodie, Zhang, Nianxian, Dayan, Gustavo H., Rouphael, Nadine, Walsh, Stephen R., Chen, Aiying, Grunenberg, Nicole, Allen, Mary, Antony, Johannes, Bhate, Amit Suresh, Beresnev, Tatiana, Bonaparte, Matthew I., Celle, Médéric, Ceregido, Maria Angeles, Corey, Lawrence, Fu, Bo, Grillet, Marie-Helene, Keshtkar-Jahromi, Maryam, Juraska, Michal, Kee, Jia Jin, Kaali, Seyram, Koutsoukos, Marguerite, Masotti, Roger, Michael, Nelson L., Neuzil, Kathleen M., Reynales, Humberto, Robb, Merlin L., Uchiyama, Akiyoshi, Sawe, Fredrick, Schuerman, Lode, Shrestha, Rajeev, Tong, Tina, Treanor, John, Diazgranados, Carlos A., Chicz, Roman M., Gurunathan, Sanjay, Savarino, Stephen, and Sridhar, Saranya

Published
2023
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3. 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

Author

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

Published
2022
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4. Immune persistence and response to booster dose of Vi-DT vaccine at 27.5 months post-first dose

Author

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

Published
2022
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5. Safety and immunogenicity of Vi-DT conjugate vaccine among 6-23-month-old children: Phase II, randomized, dose-scheduling, observer-blind Study

Author

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

Published
2020
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6. Efficacy of a monovalent (D614) SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant in adults: a phase 3, multi-country study

Author

Dayan, Gustavo H., primary, Rouphael, Nadine, additional, Walsh, Stephen R., additional, Chen, Aiying, additional, Grunenberg, Nicole, additional, Allen, Mary, additional, Antony, Johannes, additional, Bhate, Amit Suresh, additional, Beresnev, Tatiana, additional, Bonaparte, Matthew I., additional, Celle, Médéric, additional, Ceregido, Maria Angeles, additional, Corey, Lawrence, additional, Fu, Bo, additional, Grillet, Marie-Helene, additional, Keshtkar-Jahromi, Maryam, additional, Juraska, Michal, additional, Kee, Jia Jin, additional, Kaali, Seyram, additional, Koutsoukos, Marguerite, additional, Masotti, Roger, additional, Michael, Nelson L., additional, Neuzil, Kathleen M., additional, Reynales, Humberto, additional, Robb, Merlin L., additional, Uchiyama, Akiyoshi, additional, Sawe, Fredrick, additional, Schuerman, Lode, additional, Shrestha, Rajeev, additional, Tong, Tina, additional, Treanor, John, additional, Diazgranados, Carlos A., additional, Chicz, Roman M., additional, Gurunathan, Sanjay, additional, Savarino, Stephen, additional, Sridhar, Saranya, additional, Abalos, Karina, additional, Adams, Michael, additional, Allaw, Mohamed, additional, Aloysia, Naveena, additional, Amuasi, John Humphrey, additional, Ansah, Nana Akosua, additional, Asante, Kwaku Poku, additional, Benkeser, David, additional, Berge, Aude, additional, Breuer, Thomas, additional, Briesemeister, Liz, additional, Broder, Gail, additional, Bonfanti, Alberto Cadena, additional, Calinescu, Cornell, additional, Canter, Richard, additional, Carrillo, Jaime Augusto, additional, Chansinghakul, Danaya, additional, Coux, Florence, additional, Das, Chandan, additional, Davies, Matthew, additional, Devlin, Louis, additional, Fay, Michael, additional, Follmann, Dean, additional, Frago, Carina, additional, Fukase, Hiroyuki, additional, Garinga, Agnes, additional, Gilbert, Peter B., additional, Gonzalez, Claudia, additional, Granados, Maria Angelica, additional, Greiwe, Cathy, additional, Guillery, Lea, additional, Hall, Jessicalee, additional, Henderson, Jeffrey, additional, Huang, Ying, additional, Hudzina, Kathy, additional, Hural, John, additional, Hutchens, Mark, additional, Jain, Manish, additional, Jennings, William, additional, Kanodia, Piush, additional, Kimmel, Murray, additional, Kirby, William, additional, Khandelwal, Nitin, additional, Kopp, James, additional, Kosolsak, Chalit, additional, Kublin, Jim, additional, Kukian, Darshna, additional, Kushwaha, Jitendra Singh, additional, Laot, Thelma, additional, Lopez-Medina, Eduardo, additional, Arroyo, Hugo Macareno, additional, Mamod, Stephanie, additional, Mangarule, Somnath, additional, Martin, Troy, additional, Menard, Lisa, additional, Mendoza, Sandra, additional, Meyer, Robert, additional, Middleton, Randle, additional, Miracle, Jill, additional, Mizuyama, Kazuyuki, additional, Mohapatra, Satyajit, additional, Moreau, Catherine, additional, Murray, Linda, additional, Nagamatsu, Shinya, additional, Newberg, Joseph, additional, Noriega, Fernando, additional, Nugent, Paul, additional, Peake-Andrasik, Michele, additional, Pekala, David, additional, Peng, Penny, additional, Py, Marie-Laure, additional, Ramirez, Shelly, additional, Reddy, Chinthaparthi Prabhakar, additional, Reynolds, Michelle, additional, Rivas, Enrique, additional, Sater, Nessryne, additional, Shah, Jinen, additional, Sher, Lawrence, additional, Sieger, Silva, additional, Singh, Chandramani, additional, Singh, Veer Bahadur, additional, Sirisuphmitr, Nuchra, additional, Starkey, Thomas, additional, Suzuki, Kazuo, additional, Tamrakar, Dipesh, additional, Tangemen, Cayce, additional, Da-Silva, Fernanda Tavares, additional, Taylor, David, additional, Tharenos, Leslie, additional, Wartel, T. Anh, additional, Zaworski, Elodie, additional, and Zhang, Nianxian, additional

Published
2023
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7. Hepatitis E vaccine—Illuminating the barriers to use

Author

Lynch, Julia A., primary, Lim, Jacqueline Kyungah, additional, Asaga, Philomena E. Peter, additional, Wartel, T. Anh, additional, Marti, Melanie, additional, Yakubu, Beno, additional, Rees, Helen, additional, Talaat, Kawsar, additional, Kmush, Brittany, additional, Aggarwal, Rakesh, additional, Ciglenecki, Iza, additional, Gurley, Emily, additional, and Labrique, Alain B., additional

Published
2023
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8. Factors affecting willingness to participate in vaccine clinical trials in an underdeveloped country: perspective from Nepal

Author

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

Published
2022
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9. 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.

Author

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

Published
2023
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10. Challenges and opportunities in setting up a phase III vaccine clinical trial in resource limited settings: Experience from Nepal

Author

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

Published
2021
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11. Long-term immunogenicity and safety of tetravalent dengue vaccine (CYD-TDV) in healthy populations in Singapore and Vietnam: 4-year follow-up of randomized, controlled, phase II trials

Author

Tran, Ngoc Huu, primary, Chansinghakul, Danaya, additional, Chong, Chia Yin, additional, Low, Chian Yong, additional, Shek, Lynette P., additional, Luong, Chan Quang, additional, Frago, Carina, additional, Wartel, T. Anh, additional, Sun, Sunny, additional, Skipetrova, Anna, additional, and Bouckenooghe, Alain, additional

Published
2019
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13. Symptomatic Dengue Disease in Five Southeast Asian Countries: Epidemiological Evidence from a Dengue Vaccine Trial

Author

Nealon, Joshua, primary, Taurel, Anne-Frieda, additional, Capeding, Maria Rosario, additional, Tran, Ngoc Huu, additional, Hadinegoro, Sri Rezeki, additional, Chotpitayasunondh, Tawee, additional, Chong, Chee Kheong, additional, Wartel, T. Anh, additional, Beucher, Sophie, additional, Frago, Carina, additional, Moureau, Annick, additional, Simmerman, Mark, additional, Laot, Thelma, additional, L’Azou, Maïna, additional, and Bouckenooghe, Alain, additional

Published
2016
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19. The long-term impact of vaccine clinical research on national stakeholders involved: Experience from a low-income Country.

Author

Haque Pial R, Rai GK, Shrestha R, Das SK, Chapagain RH, Chaudhary S, Tamrakar D, Kanodia P, Thapa P, Vemula S, Gupta BP, Hill A, Kimathi D, Baiden R, Kim HS, Excler JL, Wartel TA, Sahastrabuddhe S, and Saluja T

Subjects
Humans, Nepal, Biomedical Research, Stakeholder Participation, Capacity Building, Developing Countries, Clinical Trials as Topic, Vaccines
Abstract

Clinical trials are the most rigorous scientific and regulated method to investigate the safety and efficacy of vaccines or drugs in pre-licensure stage. Clinical trial design and implementation are complex, time-consuming and involves close engagement with country's regulatory authority, clinical trial sites, investigators, and the healthcare system. Over the past few decades, a significant number of clinical trials have been conducted in low- and middle-income countries (LMICs), particularly in resource-limited settings. Conducting clinical research in LMICs leads to significant capacity building in terms of training and infrastructure, which adds to the improvement in overall public health benefits of the country. Here, we describe the advances in local capacities, infrastructure and healthcare system following the implementation of clinical trials with the contribution of the International Vaccine Institute at different trial sites in Nepal from 2017 to 2024 in urban, semi-urban, and rural settings. We highlight how, in addition to achieving the study-specific objectives, this experience has built local scientific, ethical, and regulatory oversight capabilities and physical infrastructure. Such positive experiences will provide additional rationale for health research organizations, pharmaceutical companies, and funders to engage in the implementation of further vaccine clinical research with LMICs which bear a heavy burden of infectious diseases.

Published
2025
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