Safety and Immunogenicity of Two Live, Attenuated Oral Shigella Sonnei Vaccines: WRSs2 and WRSs3

Summary

Phase 1, randomized, double-blind, placebo controlled, dose-escalation, inpatient study of single doses of S. sonnei. Health adult subjects, ranging in age from 18 to 45 years of age (inclusive) will be screened. Enroll serial groups up to 90 subjects. The primary objective is to evaluate safety and tolerance of WRSs2 by monitoring presence, frequency and severity of clinical signs and symptoms. A secondary objective is to evaluate the immune response in blood and stool following ingestion of WRSs2 and WRSs3.

Timeline

Start

2013-01-07

Primary completion

2015-05-12

Completion

2015-05-12

Publications

• Venkatesan MM, Ballou C, Barnoy S, McNeal M, El-Khorazaty J, Frenck R, Baqar S. Antibody in Lymphocyte Supernatant (ALS) responses after oral vaccination with live Shigella sonnei vaccine candidates WRSs2 and WRSs3 and correlation with serum antibodies, ASCs, fecal IgA and shedding. PLoS One. 2021 Nov 18;16(11):e0259361. doi: 10.1371/journal.pone.0259361. eCollection 2021.

Drugs

Indications