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Title: A human volunteer challenge model using frozen bacteria of the new epidemic serotype, V. cholerae O139 in Thai volunteers
Authors: Punnee Pitisuttithum
Mitchell B. Cohen
Benjaluck Phonrat
Usanee Suthisarnsuntorn
Valai Bussaratid
Varunee Desakorn
Weerapong Phumratanaprapin
Pratap Singhasivanon
Sornchai Looareesuwan
Gilbert M. Schiff
Bernard Ivanoff
Dennis Lang
Mahidol University
University of Cincinnati
Organisation Mondiale de la Sante
National Institute of Allergy and Infectious Diseases
Keywords: Biochemistry, Genetics and Molecular Biology;Immunology and Microbiology;Medicine;Veterinary
Issue Date: 12-Dec-2001
Citation: Vaccine. Vol.20, No.5-6 (2001), 920-925
Abstract: A total of 35 volunteers were recruited for an IRB-approved inpatient dose-escalation challenge. The goal was to identify a dose that produced an observed cholera attack rate ≥80% and an illness of sufficient severity during the defined study period such that the model would be useful for determining vaccine protection. Volunteers were challenged in groups of 5 with V. cholerae O139 that had been reconstituted immediately before use. Only 2 out of 5 volunteers who received the lowest dose (4.3 × 104cfu) had diarrhea. As the inoculum size increased, the attack rate of diarrhea increased to 3-4 of 5 volunteers. At the highest dose tested, approximately 5 × 107cfu, the attack rate was 73%. We recommend the use of frozen V. Cholera O139 in a human experimental challenge model to assess cholera vaccine efficacy (VE) in a cholera endemic area but with 4 days observation period before initiation of tetracycline to allow assessment of severity. © 2001 Elsevier Science Ltd. All rights reserved.
ISSN: 0264410X
Appears in Collections:Scopus 2001-2005

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