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.

Autor: Song KR; Clinical, Assessment, Regulatory, Evaluation Unit, International Vaccine Institute, Seoul, South Korea. Electronic address: katerina.song@ivi.int., Chapagain RH; Department of Pediatric Medicine, Kanti Children's Hospital, Kathmandu, Nepal., Tamrakar D; Center for Clinical Trial Studies, Dhulikhel Hospital, Kathmandu University Hospital, Dhulikhel, Nepal., Shrestha R; Center for Clinical Trial Studies, Dhulikhel Hospital, Kathmandu University Hospital, Dhulikhel, Nepal., Kanodia P; Department of Pediatrics and Neonatology, Nepalgunj Medical College, Nepalgunj, Nepal., Chaudhary S; Department of Pediatrics and Adolescent Medicine, BP Koirala Institute of Health Sciences, Dharan, Nepal., Wartel TA; International Vaccine Institute, Stockholm, Sweden., Yang JS; Science Unit, International Vaccine Institute, Seoul, South Korea., Kim DR; Department of Biostatistics and Data Management, International Vaccine Institute, Seoul, South Korea., Lee J; Department of Biostatistics and Data Management, International Vaccine Institute, Seoul, South Korea., Park EL; Department of Biostatistics and Data Management, International Vaccine Institute, Seoul, South Korea., Cho H; Department of Biostatistics and Data Management, International Vaccine Institute, Seoul, South Korea., Lee J; Department of Biostatistics and Data Management, International Vaccine Institute, Seoul, South Korea., Thaisrivichai P; Department of Program Management, International Vaccine Institute, Seoul, South Korea., Vemula S; Clinical, Assessment, Regulatory, Evaluation Unit, International Vaccine Institute, Seoul, South Korea., Kim BM; Clinical, Assessment, Regulatory, Evaluation Unit, International Vaccine Institute, Seoul, South Korea., Gupta B; Clinical, Assessment, Regulatory, Evaluation Unit, International Vaccine Institute, Seoul, South Korea., Saluja T; Clinical, Assessment, Regulatory, Evaluation Unit, International Vaccine Institute, Seoul, South Korea., Pansuriya RK; Vaccine Process Development Unit, International Vaccine Institute, Seoul, South Korea; Graduate School of Public Health, Yonsei University, Seoul, South Korea., Ganapathy R; Research and Development, Hilleman Laboratories, Singapore., Baik YO; Research and Development Division, EuBiologics, Seoul, South Korea., Lee YJ; Research and Development Division, EuBiologics, Seoul, South Korea., Jeon S; Production Division, EuBiologics, Seoul, South Korea., Park Y; Business Division, EuBiologics, Seoul, South Korea., Her HL; Research and Development Division, EuBiologics, Seoul, South Korea., Park Y; Production Division, EuBiologics, Seoul, South Korea., Lynch JA; Clinical, Assessment, Regulatory, Evaluation Unit, International Vaccine Institute, Seoul, South Korea.

Publikováno v: The Lancet. Global health [Lancet Glob Health] 2024 May; Vol. 12 (5), pp. e826-e837.

Efficacy of a bivalent (D614 + B.1.351) SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant in adults: a phase 3, parallel, randomised, modified double-blind, placebo-controlled trial.

Autor: Dayan GH; Sanofi, Swiftwater, PA, USA. Electronic address: gustavo.dayan@sanofi.com., Rouphael N; Emory University Hope Clinic, Atlanta, GA, USA., Walsh SR; Harvard Medical School, Boston, MA, USA., Chen A; Sanofi, Swiftwater, PA, USA., Grunenberg N; Fred Hutchinson Cancer Center, Seattle, WA, USA., Allen M; National Institute of Allergy and Infectious Diseases / National Institutes of Health, Bethesda, MD, USA., Antony J; Sanofi, Frankfurt, Germany., Asante KP; Research and Development Division, Ghana Health Service, Kintampo North Municipality, Ghana., Bhate AS; Jeevan Rekha Hospital, Belgavi, India., Beresnev T; National Institute of Allergy and Infectious Diseases / National Institutes of Health, Bethesda, MD, USA., Bonaparte MI; Sanofi, Swiftwater, PA, USA., Celle M; Sanofi, Marcy l'Etoile, France., Ceregido MA; GlaxoSmithKline, Wavre, Belgium., Corey L; Fred Hutchinson Cancer Center, Seattle, WA, USA., Dobrianskyi D; Medical Centre, Medical Clinic Blagomed, Kyiv, Ukraine., Fu B; National Institute of Allergy and Infectious Diseases / National Institutes of Health, Bethesda, MD, USA., Grillet MH; Sanofi, Lyon, France., Keshtkar-Jahromi M; National Institutes of Health, Rockville, MD, USA; John Hopkins University School of Medicine, Baltimore, MD, USA., Juraska M; Fred Hutchinson Cancer Center, Seattle, WA, USA., Kee JJ; Fred Hutchinson Cancer Center, Seattle, WA, USA., Kibuuka H; Makerere University Walter Reed Project, Kampala, Uganda., Koutsoukos M; GlaxoSmithKline, Wavre, Belgium., Masotti R; Sanofi, Swiftwater, PA, USA., Michael NL; Walter Reed Army Institute of Research, Silver Spring, MD, USA., Neuzil KM; University of Maryland School of Medicine, Baltimore, MD, USA., Reynales H; Centro de Attencion e Investigation Medica S.A.S. - Caimed Chía, Chía, Colombia., Robb ML; The Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MA, USA., Villagómez Martínez SM; Hospital de Temixco en acuerdo con el Instituto Nacional de Pediatria, Temixco, México., Sawe F; Kenya Medical Research Institute - US Army Medical Research, Kericho, Kenya., Schuerman L; GlaxoSmithKline, Wavre, Belgium., Tong T; National Institute of Allergy and Infectious Diseases / National Institutes of Health, Bethesda, MD, USA., Treanor J; Tunnell Government Services in support of Biomedical Advanced Research and Development Authority, Administration for Strategic Preparedness and Response, Department of Health and Human Services, Washington, DC, USA., Wartel TA; International Vaccine Institute, Seoul, South Korea., Diazgranados CA; Sanofi, Swiftwater, PA, USA., Chicz RM; Sanofi, Cambridge, MA, USA., Gurunathan S; Sanofi, Swiftwater, PA, USA., Savarino S; Sanofi, Swiftwater, PA, USA., Sridhar S; Sanofi, Reading, UK.

Publikováno v: The Lancet. Respiratory medicine [Lancet Respir Med] 2023 Nov; Vol. 11 (11), pp. 975-990. Date of Electronic Publication: 2023 Sep 13.

Hepatitis E vaccine-Illuminating the barriers to use.

Autor: Lynch JA; International Vaccine Institute, Seoul, Korea., Lim JK; International Vaccine Institute, Seoul, Korea., Asaga PEP; International Vaccine Institute, Seoul, Korea., Wartel TA; International Vaccine Institute, Seoul, Korea., Marti M; Department of Immunization, Vaccines and Biologicals, World Health Organization, Geneva, Switzerland., Yakubu B; National Agency for Food and Drug Administration and Control (NAFDAC), Nigeria., Rees H; Wits RHI, University of the Witwatersrand, Johannesburg, South Africa., Talaat K; Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United States of America., Kmush B; Department of Public Health, Syracuse University, Syracuse, New York, United States of America., Aggarwal R; Department of Gastroenterology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India., Ciglenecki I; Médecins sans Frontières, Geneva, Switzerland., Gurley E; Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United States of America., Labrique AB; Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United States of America.

Publikováno v: PLoS neglected tropical diseases [PLoS Negl Trop Dis] 2023 Jan 05; Vol. 17 (1), pp. e0010969. Date of Electronic Publication: 2023 Jan 05 (Print Publication: 2023).

Immune non-interference and safety study of Vi-DT typhoid conjugate vaccine with a measles, mumps and rubella containing vaccine in 9-15 months old Nepalese infants.

Autor: Saluja T; International Vaccine Institute, Seoul, Republic of Korea. Electronic address: Tarun.Saluja@ivi.int., Rai GK; Kanti Children's Hospital, Kathmandu, Nepal., Chaudhary S; B P Koirala Institute of Health Sciences, Dharan, Nepal., Kanodia P; Nepalgunj Medical College, Nepalgunj, Nepal., Giri BR; Kanti Children's Hospital, Kathmandu, Nepal., Kim DR; International Vaccine Institute, Seoul, Republic of Korea., Yang JS; International Vaccine Institute, Seoul, Republic of Korea., Park IY; International Vaccine Institute, Seoul, Republic of Korea., Kyung SE; International Vaccine Institute, Seoul, Republic of Korea., Vemula S; International Vaccine Institute, Seoul, Republic of Korea., Reddy E J; International Vaccine Institute, Seoul, Republic of Korea., Kim B; International Vaccine Institute, Seoul, Republic of Korea., Gupta BP; International Vaccine Institute, Seoul, Republic of Korea., Jo SK; International Vaccine Institute, Seoul, Republic of Korea., Ryu JH; SK bioscience, Seoul, Republic of Korea., Park HK; SK bioscience, Seoul, Republic of Korea., Shin JH; SK bioscience, Seoul, Republic of Korea., Lee Y; SK bioscience, Seoul, Republic of Korea., Kim H; SK bioscience, Seoul, Republic of Korea., Kim JH; International Vaccine Institute, Seoul, Republic of Korea., Mojares ZR; International Vaccine Institute, Seoul, Republic of Korea., Wartel TA; International Vaccine Institute, Seoul, Republic of Korea., Sahastrabuddhe S; International Vaccine Institute, Seoul, Republic of Korea.

Publikováno v: Vaccine [Vaccine] 2022 Sep 22; Vol. 40 (40), pp. 5828-5834. Date of Electronic Publication: 2022 Sep 03.

Safety and immunogenicity of the Vi-DT typhoid conjugate vaccine in healthy volunteers in Nepal: an observer-blind, active-controlled, randomised, non-inferiority, phase 3 trial.

Autor: Kumar Rai G; Department of Pediatrics, Kanti Children's Hospital, Kathmandu, Nepal., Saluja T; International Vaccine Institute, SNU Research Park, Seoul, South Korea. Electronic address: tarun.saluja@ivi.int., Chaudhary S; Department of Pediatrics and Medicine, B P Koirala Institute of Health Sciences, Dharan, Nepal., Tamrakar D; Department of Community Medicine and Pharmacology, Dhulikhel Hospital, Kathmandu University Hospital, Dhulikhel, Nepal., Kanodia P; Department of Pediatrics, Nepalgunj Medical College, Nepalgunj, Nepal., Giri BR; Department of Pediatrics, Kanti Children's Hospital, Kathmandu, Nepal., Shrestha R; Department of Community Medicine and Pharmacology, Dhulikhel Hospital, Kathmandu University Hospital, Dhulikhel, Nepal., Uranw S; Department of Pediatrics and Medicine, B P Koirala Institute of Health Sciences, Dharan, Nepal., Kim DR; International Vaccine Institute, SNU Research Park, Seoul, South Korea., Yang JS; International Vaccine Institute, SNU Research Park, Seoul, South Korea., Park IY; International Vaccine Institute, SNU Research Park, Seoul, South Korea., Kyung SE; International Vaccine Institute, SNU Research Park, Seoul, South Korea., Vemula S; International Vaccine Institute, SNU Research Park, Seoul, South Korea., Reddy E J; International Vaccine Institute, SNU Research Park, Seoul, South Korea., Kim B; International Vaccine Institute, SNU Research Park, Seoul, South Korea., Gupta BP; International Vaccine Institute, SNU Research Park, Seoul, South Korea., Jo SK; International Vaccine Institute, SNU Research Park, Seoul, South Korea., Ryu JH; SK Bioscience, Seoul, South Korea., Park HK; SK Bioscience, Seoul, South Korea., Shin JH; SK Bioscience, Seoul, South Korea., Lee Y; SK Bioscience, Seoul, South Korea., Kim H; SK Bioscience, Seoul, South Korea., Kim JH; International Vaccine Institute, SNU Research Park, Seoul, South Korea., Mojares ZR; International Vaccine Institute, SNU Research Park, Seoul, South Korea., Wartel TA; International Vaccine Institute, SNU Research Park, Seoul, South Korea., Sahastrabuddhe S; International Vaccine Institute, SNU Research Park, Seoul, South Korea.

Publikováno v: The Lancet. Infectious diseases [Lancet Infect Dis] 2022 Apr; Vol. 22 (4), pp. 529-540. Date of Electronic Publication: 2021 Dec 20.