{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T05:45:11Z","timestamp":1791265511367,"version":"4.1.0"},"reference-count":18,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,12,19]],"date-time":"2022-12-19T00:00:00Z","timestamp":1671408000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,12,19]],"date-time":"2022-12-19T00:00:00Z","timestamp":1671408000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["npj Vaccines"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Yellow fever, a mosquito-borne flavivirus infection, is an important public health problem in Africa and Latin America. A Yellow Fever vaccine (YFV) was developed and tested in a study in India. This was a Phase I, open-label, randomized, controlled study where healthy adults received SII YFV intramuscularly (SII YFV IM), SII YFV subcutaneously (SII YFV SC) or STAMARIL\n                    <jats:sup>\u00ae<\/jats:sup>\n                    (Sanofi-Pasteur) in 1:1:1 ratio. They were followed for solicited reactions for 10 days and unsolicited events for 28 days and serious adverse events for 3 months. YF-neutralizing antibodies were measured at baseline and on Days 10, 14, 28. A total of 60 adults were enrolled in the study. The proportion of participants with solicited reactions was 10%, 40%, and 25% in SII YFV SC, SII YFV IM, and STAMARIL\n                    <jats:sup>\u00ae<\/jats:sup>\n                    arms, respectively. No causally related unsolicited events or any serious adverse event was reported. After vaccination, the seroconversion was 94.44%, 100%, and 100%, in the three arms respectively. The post-vaccination geometric mean titers were similar in the study arms. The new YFV was found safe and immunogenic by IM as well as SC routes. The vaccine can be tested in further phases of clinical studies.\n                  <\/jats:p>","DOI":"10.1038\/s41541-022-00595-6","type":"journal-article","created":{"date-parts":[[2022,12,19]],"date-time":"2022-12-19T10:02:57Z","timestamp":1671444177000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["A phase I clinical study to assess safety and immunogenicity of yellow fever vaccine"],"prefix":"10.1038","volume":"7","author":[{"given":"Sajjad","family":"Desai","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"Anil","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anirudha Vyankatesh","family":"Potey","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Y.","family":"Sindhu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvia","family":"Grappi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3596-9578","authenticated-orcid":false,"given":"Giulia","family":"Lapini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satyaprasad","family":"Manney","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Parikshit","family":"Tyagi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emanuele","family":"Montomoli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cyrus S.","family":"Poonawalla","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3625-9236","authenticated-orcid":false,"given":"Prasad S.","family":"Kulkarni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,12,19]]},"reference":[{"key":"595_CR1","unstructured":"World Health Organization. Yellow Fever Factsheet. Available at: https:\/\/www.who.int\/news-room\/fact-sheets\/detail\/yellow-fever. (Accessed: 5th December 2019)."},{"key":"595_CR2","unstructured":"Centers for Disease Control and Prevention (CDC). Global Health - Newsroom - Yellow Fever. (2018). Available at: https:\/\/www.cdc.gov\/globalhealth\/newsroom\/topics\/yellowfever\/index.html. (Accessed: 2nd July 2022)."},{"key":"595_CR3","unstructured":"World Health Organization. Immunization coverage. (2022). Available at: https:\/\/www.who.int\/news-room\/fact-sheets\/detail\/immunization-coverage. (Accessed: 29th July 2022)."},{"key":"595_CR4","unstructured":"European Center for Disease Prevention and Control. Yellow fever: Annual Epidemiological Report. (2019)."},{"key":"595_CR5","unstructured":"World Health Organization. 2019, Yellow fever, ICG annual meeting report. (2020). Available at: https:\/\/www.who.int\/publications\/i\/item\/9789240008236. (Accessed: 29th July 2022)."},{"key":"595_CR6","unstructured":"World Health Organization. A Global Strategy to Eliminate Yellow Fever Epidemics (EYE) 2017\u20132026. (2018)."},{"key":"595_CR7","unstructured":"World Health Organization. Yellow Fever - West and Central Africa. (2021). Available at: https:\/\/www.who.int\/emergencies\/disease-outbreak-news\/item\/yellow-fever---west-and-central-africa. (Accessed: 2nd July 2022)."},{"key":"595_CR8","doi-asserted-by":"publisher","first-page":"119","DOI":"10.1016\/S0140-6736(20)32520-4","volume":"397","author":"A Juan-Giner","year":"2021","unstructured":"Juan-Giner, A. et al. Immunogenicity and safety of fractional doses of yellow fever vaccines: a randomised, double-blind, non-inferiority trial. Lancet 397, 119\u2013127 (2021).","journal-title":"Lancet"},{"key":"595_CR9","doi-asserted-by":"publisher","first-page":"444","DOI":"10.1056\/NEJMoa1710430","volume":"381","author":"RM Casey","year":"2019","unstructured":"Casey, R. M. et al. Immunogenicity of fractional-dose vaccine during a yellow fever outbreak \u2014 final report. N. Engl. J. Med. 381, 444\u2013454 (2019).","journal-title":"N. Engl. J. Med."},{"key":"595_CR10","unstructured":"Pan American Health Organization (PAHO). Brazil launches world\u2019s largest campaign with fractional-dose yellow fever vaccine. Web Bulletins (2018). Available at: https:\/\/www3.paho.org\/hq\/index.php?option=com_content&view=article&id=14065:brazil-launches-worlds-largest-campaign-with-fractional-dose-yellow-fever-vaccine&Itemid=135&lang=fr. (Accessed: 3rd August 2022)."},{"key":"595_CR11","first-page":"345","volume":"92","author":"World Health Organization.","year":"2017","unstructured":"World Health Organization. Yellow fever vaccine: WHO position on the use of fractional doses \u2013 June 2017. Wkly. Epidemiol. Rec. = Relev. \u00e9pid\u00e9miologique Hebd. 92, 345\u2013350 (2017).","journal-title":"Wkly. Epidemiol. Rec. = Relev. \u00e9pid\u00e9miologique Hebd."},{"key":"595_CR12","doi-asserted-by":"crossref","unstructured":"Montalvo Zurbia-Flores, G., Rollier, C. S. & Reyes-Sandoval, A. Re-thinking yellow fever vaccines: fighting old foes with new generation vaccines. Hum. Vaccin. Immunother. 18, 1895644 (2022).","DOI":"10.1080\/21645515.2021.1895644"},{"key":"595_CR13","unstructured":"MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION. Instruction on application of Yellow Fever Vaccine, live freeze-dried, lyophilizate for preparing the solution for intramuscular\/subcutaneous injections."},{"key":"595_CR14","unstructured":"Sanofi Pasteur. Stamaril powder and solvent for suspension for injection in pre-filled syringe - summary of product characteristics (SmPC). EMC. Available at: https:\/\/www.medicines.org.uk\/emc\/product\/1683\/smpc. (2019)."},{"key":"595_CR15","doi-asserted-by":"publisher","first-page":"113","DOI":"10.1093\/oxfordjournals.aje.a118875","volume":"38","author":"JP Fox","year":"1943","unstructured":"Fox, J. P., Kossobudzki, S. L. & Da Cunha, J. F. Field studies on the immune response to 17d yellow fever virus: relation to virus substrain, dose, and route of inoculation. Am. J. Epidemiol. 38, 113\u2013138 (1943).","journal-title":"Am. J. Epidemiol."},{"key":"595_CR16","doi-asserted-by":"publisher","first-page":"339","DOI":"10.4269\/ajtmh.2005.72.339","volume":"72","author":"M Pfister","year":"2005","unstructured":"Pfister, M. et al. Immunogenicity and safety of BERNA-YF compared with two other 17D yellow fever vaccines in a phase 3 clinical trial. Am. J. Trop. Med. Hyg. 72, 339\u2013346 (2005).","journal-title":"Am. J. Trop. Med. Hyg."},{"key":"595_CR17","doi-asserted-by":"publisher","first-page":"160","DOI":"10.1016\/j.jcv.2014.08.030","volume":"64","author":"TP Monath","year":"2015","unstructured":"Monath, T. P. & Vasconcelos, P. F. C. Yellow fever. J. Clin. Virol. 64, 160\u2013173 (2015).","journal-title":"J. Clin. Virol."},{"key":"595_CR18","doi-asserted-by":"crossref","unstructured":"Staples, J. E., Monath, T. P., Gershman, M. D. & Barrett, A. D. T. Yellow Fever Vaccines. in Plotkin\u2019s Vaccines (eds. Plotkin, S. A., Orenstein, W. A., Offit, P. A. & Edwards, K. M.) 1181\u20131265 (Elsevier, 2018).","DOI":"10.1016\/B978-0-323-35761-6.00063-8"}],"container-title":["npj Vaccines"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.nature.com\/articles\/s41541-022-00595-6.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41541-022-00595-6","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41541-022-00595-6.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,12,19]],"date-time":"2022-12-19T10:05:25Z","timestamp":1671444325000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.nature.com\/articles\/s41541-022-00595-6"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,12,19]]},"references-count":18,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2022,12]]}},"alternative-id":["595"],"URL":"https:\/\/doi.org\/10.1038\/s41541-022-00595-6","relation":{"has-preprint":[{"id-type":"doi","id":"10.21203\/rs.3.rs-1996162\/v1","asserted-by":"object"}]},"ISSN":["2059-0105"],"issn-type":[{"value":"2059-0105","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,12,19]]},"assertion":[{"value":"25 August 2022","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"6 December 2022","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"19 December 2022","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"S.D., A.V.P., S.M., P.T., and P.S.K are employees of Serum Institute of India Pvt. Ltd. (SIIPL). C.S.P. is the chairman and managing director of SIIPL. A.K., S.Y., S.G., G.L., and E.M. have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"All participants were enrolled only after obtaining written informed consent. The study protocol and documents were approved by the People Tree Hospital Ethics Committee. The study was performed in accordance with the International Conference on Harmonization Guidelines for Good Clinical Practice E6 (R2), New Drugs and Clinical Trials Rules, 2019 by CDSCO and the Declaration of Helsinki, 2013.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics"}},{"value":"The study was approved by the Drugs Controller General of India. The study is registered on the clinical trial registry of India (CTRI\/2020\/09\/027594).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Regulatory compliance"}}],"article-number":"170"}}