GSK4001785A / GSK - LARVOL DELTA

A Study on the Immune Response and Safety of a Multicomponent Shigella Vaccine in Preventing Shigellosis in Infants (clinicaltrials.gov) - P2 | N=200 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion

A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants (clinicaltrials.gov) - P1 | N=551 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion

Antibodies elicited by altSonflex1-2-3 GMMA vaccine are bactericidal against a panel of drug-resistant Shigella clinical isolates. (PubMed, Front Immunol) - "Preclinical sera elicited by altSonflex1-2-3 were bactericidal against most strains, confirming the ability of anti-O-antigen antibodies to recognize and kill in vitro different clinical isolates. Importantly, our results suggest that altSonflex1-2-3 could offer protection against antimicrobial-resistant Shigella strains, addressing a critical public health issue."

Journal • Infectious Disease

A Study on the Immune Response and Safety of a Multicomponent Shigella Vaccine in Preventing Shigellosis in Infants (clinicaltrials.gov) - P2 | N=200 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants (clinicaltrials.gov) - P1 | N=552 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting | Phase classification: P1/2 ➔ P1

Enrollment closed • Phase classification

A Study on the Immune Response and Safety of a Multicomponent Shigella Vaccine in Preventing Shigellosis in Infants (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open

A study on the immunogenicity and safety of a multicomponent Shigella vaccine in preventing shigellosis in infants (clinicaltrialsregister.eu) - P2 | N=200 | Sponsor: GlaxoSmithKline Biologicals

New P2 trial • Dermatology • Infectious Disease

A Study on the Immune Response and Safety of a Multicomponent Shigella Vaccine in Preventing Shigellosis in Infants (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P2 trial

Safety and immunogenicity of a 4-component GMMA-based Shigella vaccine in healthy European adults: Stage 1 of a randomized, controlled phase I/II clinical trial. (PubMed, J Infect Dis) - P1/2 | "No safety signals or concerns were identified. altSonflex1-2-3 induced functional serotype-specific immune responses, allowing further clinical development in the target population."

Clinical • Journal • P1/2 data • Pain

Comparison of Shigella GMMA and glycoconjugate four-component formulations in animals. (PubMed, Front Mol Biosci) - "Generalized Modules for Membrane Antigens (GMMA) have been proposed as an alternative delivery system for the O-antigen, and a 4-component vaccine candidate (altSonflex1-2-3), containing GMMA from S. sonnei and S. flexneri 1b, 2a and 3a is being tested in a phase 1/2 clinical trial, with the aim to elicit broad protection against the most prevalent Shigella serotypes...In rabbits, GMMA elicit higher functional antibodies than glycoconjugates against S. sonnei, and similar responses to S. flexneri 1b, 2a and 3a, independently from the presence of Alhydrogel. Different O-antigen based vaccines against Shigella are now in clinical stage and it will be of particular interest to understand how the preclinical findings in the different animal models translate in humans."

Journal

A next-generation GMMA-based vaccine candidate to fight shigellosis. (PubMed, NPJ Vaccines) - "A GLP toxicology study in rabbits confirmed that the vaccine was well tolerated. The preclinical study results support the clinical evaluation of altSonflex1-2-3 in healthy populations, and a phase 1-2 clinical trial is currently ongoing."

Journal

A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants (clinicaltrials.gov) - P1/2 | N=550 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Jul 2024 ➔ Apr 2025 | Trial primary completion date: Jul 2024 ➔ Apr 2025

Trial completion date • Trial primary completion date

From an in vivo to an in vitro relative potency (IVRP) assay to fully characterize a multicomponent O-antigen based vaccine against Shigella. (PubMed, Carbohydr Polym) - "altSonflex1-2-3 is a GMMA based vaccine, including S. sonnei and S. flexneri 1b, 2a and 3a O-Antigens, with the aim to elicit broad protection against the most prevalent Shigella serotypes, especially affecting children in low-middle income countries...The entire panel of physico-chemical methods developed will contribute to detect suboptimal batches and will be valuable to perform stability studies. The work on Shigella vaccine candidate can be easily extended to other O-Antigen based vaccines."

Journal • Preclinical • Infectious Disease

A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants (clinicaltrials.gov) - P1/2 | N=550 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Apr 2024 ➔ Jul 2024 | Trial primary completion date: Apr 2024 ➔ Jul 2024

Trial completion date • Trial primary completion date

A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants (clinicaltrials.gov) - P1/2; N=550; Recruiting; Sponsor: GlaxoSmithKline; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • PCR