oral live-attenuated Shigella sonnei vaccine (WRSs2) / National Institute of Allergy and Infectious Diseases - LARVOL DELTA

Phase 2 Shigella Vaccine and Challenge (clinicaltrials.gov) - P2 | N=69 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | N=108 ➔ 69

Enrollment change • Infectious Disease

Phase 2 Shigella Vaccine and Challenge (clinicaltrials.gov) - P2 | N=108 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Completed | N=69 ➔ 108

Enrollment change • Trial completion • Infectious Disease

Phase 2 Shigella Vaccine and Challenge (clinicaltrials.gov) - P2 | N=69 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting ➔ Active, not recruiting | N=120 ➔ 69

Enrollment change • Enrollment closed • Infectious Disease

B memory cell responses to LPS, IVP and IpaB antigen after oral vaccination with Shigella sonnei vaccine candidates WRSs2 and WRSs3. (PubMed, PLoS One) - "The baseline as well as post-vaccination levels of IgA+ BM cells were relatively higher than IgG+ BM cells, but the maximum fold-increase at d28/d56 over baseline was greater for IgG+ than IgA+ BM cell responses. Furthermore, at the three highest vaccine doses, >60-90% of subjects were considered responders indicating a ≥2-fold higher IgG+ BM cell responses to IVP and IpaB post vaccination, while fewer subjects indicated the same level of response to LPS."

Journal

Phase 2 Shigella Vaccine and Challenge (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Suspended ➔ Recruiting

Enrollment open • Infectious Disease

Phase 2 Shigella Vaccine and Challenge (clinicaltrials.gov) - P2 | N=120 | Suspended | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting ➔ Suspended

Trial suspension • Infectious Disease

Phase 2 Shigella Vaccine and Challenge (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Trial completion date: Jun 2023 ➔ Jul 2024 | Trial primary completion date: Jun 2023 ➔ Jul 2024

Trial completion date • Trial primary completion date • Infectious Disease

Phase 2 Shigella Vaccine and Challenge (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Trial completion date: Jan 2023 ➔ Jun 2023 | Trial primary completion date: Jan 2023 ➔ Jun 2023

Trial completion date • Trial primary completion date • Infectious Disease

Phase 2 Shigella Vaccine and Challenge (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease

Phase 2 Shigella Vaccine and Challenge (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Trial primary completion date: Jun 2022 ➔ Jan 2023

Trial primary completion date • Infectious Disease

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. (PubMed, PLoS One) - P1 | "It is hoped that an antigen-specific-ALS titer may be a key mucosal correlate of protection, a feature not currently available for any Shigella vaccines candidates. https://clinicaltrials.gov/show/NCT01336699."

Journal • Immunology

Phase 2 Shigella Vaccine and Challenge (clinicaltrials.gov) - P2; N=120; Not yet recruiting; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Trial completion date: Apr 2022 ➔ Jan 2023

Clinical • Trial completion date