{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T08:38:37Z","timestamp":1784191117336,"version":"3.55.0"},"reference-count":50,"publisher":"American Society of Tropical Medicine and Hygiene","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,1,8]]},"abstract":"<jats:p>The attenuated recombinant <jats:italic>Vibrio cholerae<\/jats:italic> O1 vaccine strain CVD 103-HgR, redeveloped as PXVX0200, elicits a rapid serum vibriocidal antibody (SVA) response and protects against cholera-induced diarrhea in adult volunteer challenge trials but has not been studied in children in developed countries. We performed a phase 4, placebo-controlled, double-blind, multicenter study to assess the safety, immunogenicity, and tolerability of a single, oral dose of PXVX0200 in children and adolescents aged 6\u201317 years in the United States and bridged immunogenicity to adults aged 18\u201345 years from a separate lot consistency study. Volunteers were randomized to receive a single dose of 1 \u00d7 10<jats:sup>9<\/jats:sup> colony forming units (CFU) of PXVX0200 or placebo. Immunogenicity endpoints included SVA levels on days 1, 11, and 29 in volunteers aged 6\u201317 years and also on days 91 and 181 in volunteers aged 12\u201317 years. Safety was assessed by comparing solicited signs and symptoms on days 1\u20138, unsolicited adverse events (AEs) through day 29, and serious AEs through day 181. A total of 374 participants were enrolled, comprising 321 vaccine and 53 placebo recipients. The SVA seroconversion rates 10 days after immunization were 98.6% and 2.1% in vaccine and placebo recipients, respectively, and the vaccine seroconversion rate was non-inferior to the 93.5% rate seen in adults aged 18\u201345 years. Most reactogenicity was mild to moderate, and there were no vaccine-related serious AEs. The complete dose was consumed in 95.3% and 98.1% of vaccine and placebo recipients, respectively. PXVX0200 appears safe, immunogenic, and well tolerated in children and adolescents aged 6\u201317 years.<\/jats:p>","DOI":"10.4269\/ajtmh.19-0241","type":"journal-article","created":{"date-parts":[[2019,11,26]],"date-time":"2019-11-26T07:00:50Z","timestamp":1574751650000},"page":"48-57","source":"Crossref","is-referenced-by-count":8,"title":["Safety and Immunogenicity of Live Oral Cholera Vaccine CVD 103-HgR in Children and Adolescents Aged 6\u201317 Years"],"prefix":"10.4269","volume":"102","author":[{"given":"James M.","family":"McCarty","sequence":"first","affiliation":[{"name":"Stanford University School of Medicine, Stanford, California;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emma C.","family":"Gierman","sequence":"additional","affiliation":[{"name":"PaxVax, Inc., Redwood City, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"Bedell","sequence":"additional","affiliation":[{"name":"PaxVax, Inc., Redwood City, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael D.","family":"Lock","sequence":"additional","affiliation":[{"name":"PaxVax, Inc., Redwood City, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sean","family":"Bennett","sequence":"additional","affiliation":[{"name":"PaxVax, Inc., Redwood City, California"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2795","reference":[{"key":"b1","series-title":"Curr Opin Infect Dis","first-page":"1","article-title":"Cholera: recent updates","volume":"31","author":"Weil","year":"2018"},{"key":"b2","series-title":"Lancet Glob Health","first-page":"e680","article-title":"Cholera epidemic in Yemen, 2016\u201318: an analysis of surveillance data","volume":"6","author":"Camacho","year":"2018"},{"key":"b3","series-title":"Epidemiol Bull","first-page":"1","article-title":"Cholera situation in the Americas: an update","volume":"12","author":"Organization Pan American Health","year":"1991"},{"key":"b4","series-title":"Emerg Infect Dis","first-page":"2166","article-title":"Cholera in the United States associated with epidemic in Hispaniola","volume":"17","author":"Newton","year":"2011"},{"key":"b5","series-title":"PLoS Negl Trop Dis","first-page":"e0003832","article-title":"Updated global burden of cholera in endemic countries","volume":"9","author":"Ali","year":"2015"},{"key":"b6","series-title":"Epidemiol Infect","first-page":"9","article-title":"An outbreak of cholera from food served on an international aircraft","volume":"116","author":"Eberhart-Phillips","year":"1996"},{"key":"b7","series-title":"Scand J Infect Dis","first-page":"73","article-title":"Mixed diarrhoeal infection caused by Vibrio cholerae and several other enteric pathogens in a 4-year-old child returning to Germany from Pakistan","volume":"37","author":"Enzensberger","year":"2005"},{"key":"b8","series-title":"Travel Med Infect Dis","first-page":"236","article-title":"Cholera gravis associated with acute renal failure in a traveler from Haiti to the United States","volume":"10","author":"Reyes-Corcho","year":"2012"},{"key":"b9","series-title":"Wkly Epidemiol Rec","first-page":"477","article-title":"Cholera vaccines: WHO position paper-August 2017","volume":"92","author":"World Health Organization","year":"2017"},{"key":"b10","series-title":"Bull World Health Organ","first-page":"777","article-title":"The relationship of vibriocidal antibody titre to susceptibility to cholera in family contacts of cholera patients","volume":"38","author":"Mosley","year":"1968"},{"key":"b11","series-title":"Bull World Health Organ","first-page":"187","article-title":"Report of the 1966\u201367 cholera vaccine field trial in rural East Pakistan. 2. 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