A Phase I trial to evaluate the safety and immunogenicity of WRSs2 and WRSs3; two live oral candidate vaccines against Shigella sonnei.

ABSTRACT: Effective vaccines are needed to combat diarrheal diseases due to Shigella. Two live oral S. sonnei vaccine candidates, WRSs2 and WRSs3, attenuated principally by the lack of spreading ability, as well as the loss of enterotoxin and acyl transferase genes, were tested for safety and immunogenicity. Healthy adults 18-45 years of age, assigned to 5 cohorts of 18 subjects each (WRSs2 (n = 8), WRSs3 (n = 8) or placebo (n = 2)) were housed in an inpatient facility and administered a single oral dose of study agent 5 min after ingestion of oral bicarbonate. Ascending dosages of vaccine (from 10³ CFU to 10⁷ CFU) were evaluated. On day 8, treatment with ciprofloxacin (500 mg BID for 3 days) was initiated and subjects were discharged home 2 days after completing antibiotics. S

SUBMITTER: Frenck RW 

PROVIDER: S-EPMC10559265 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature