GSK4077164 / GSK - LARVOL DELTA

A Study on the Safety, Reactogenicity, and Immune Response to the GVGH iNTS-GMMA Vaccine Against Invasive Nontyphoidal Salmonella in Adults, Children, and Infants (clinicaltrials.gov) - P2 | N=183 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease

Development of a GMMA-based candidate vaccine against invasive nontyphoidal Salmonella disease. (PubMed, Front Immunol) - "Additionally, the highest envisioned human dose of iNTS-GMMA was well tolerated in a GLP repeated-dose toxicology study in rabbits. These data supported clinical evaluation of this urgently needed vaccine against iNTS disease in sSA."

Journal • Infectious Disease

A Study on the Safety, Reactogenicity, and Immune Response to the GVGH iNTS-GMMA Vaccine Against Invasive Nontyphoidal Salmonella in Adults, Children, and Infants (clinicaltrials.gov) - P2 | N=215 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting | N=516 ➔ 215 | Trial completion date: Apr 2026 ➔ Sep 2026 | Trial primary completion date: Apr 2026 ➔ Sep 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease

A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella Disease and Typhoid Fever in Infants (clinicaltrials.gov) - P2 | N=537 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease

A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella Disease and Typhoid Fever in Infants (clinicaltrials.gov) - P2 | N=537 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P2 trial • Infectious Disease

A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella and Typhoid Fever (clinicaltrials.gov) - P1/2 | N=155 | Completed | Sponsor: GlaxoSmithKline | Recruiting ➔ Completed

Trial completion • Infectious Disease

Safety and immunogenicity of the invasive non-typhoidal Salmonella (iNTS)-GMMA vaccine: a first-in-human, randomised, dose escalation trial. (PubMed, EBioMedicine) - "The iNTS-GMMA vaccine was immunogenic and did not show safety concerns precluding further development, supporting progression to further phase I and II clinical trials."

Journal • P1 data • Infectious Disease

GMMA-based vaccine candidates against invasive nontyphoidal salmonellosis elicit bactericidal antibodies against a panel of epidemiologically relevant Salmonellae. (PubMed, Front Immunol) - "We are developing a bivalent formulation of Salmonella Typhimurium and Salmonella Enteritidis generalized modules for membrane antigens (GMMA)-based vaccine (iNTS-GMMA) and a trivalent formulation (iNTS-TCV) in which iNTS-GMMA is combined with the WHO-prequalified TYPHIBEV (Biological E, India) vaccine to prevent typhoid fever in addition to invasive NTS (iNTS) disease...These organisms include those causing invasive disease in Africa and Southeast Asia, global representatives causing gastroenteritis and other S. enterica serovars in addition to S. Typhimurium and S. Enteritidis. We characterized the O-antigen of the panel of isolates and demonstrated the sera functionality in both animal species against all isolates, providing evidence of the potential broad coverage of both GMMA-based formulations, which are currently undergoing testing in Phase I/II clinical trials."

Journal • Gastroenterology • Gastrointestinal Disorder • Infectious Disease

Interim safety data from a phase 1/2a, randomized, controlled, observer-blind trial to evaluate the safety, reactogenicity and immunogenicity of a trivalent vaccine against invasive nontyphoidal Salmonellosis (iNTS) and Typhoid Fever in healthy . (ASTMH 2024) - "In stage 1, 50 European adults were randomized in a 2:2:1 ratio to receive either iNTS-TCV vaccine and concomitant saline in different arms, or separate iNTS-GMMA and TCV vaccines in different arms, or placebo and saline in different arms intramuscularly, on Days 1, 57 and 169...Menveo, Boostrix and Typhim Vi are administered as controls for the 1 st , 2 nd and 3 rd doses respectively...In conclusion, based on available data, the anticipated benefit/risk profile of the iNTS-TCV vaccine continues to be positive, with no safety concerns precluding further clinical development. First immunogenicity results are expected later in 2024 and would be presented at the congress."

Clinical • P1/2 data • Fatigue • Infectious Disease • Musculoskeletal Pain • Pain

A study on the safety, reactogenicity, and immune response to the GVGH iNTS-GMMA vaccine against invasive nontyphoidal Salmonella in adults, children, and infants. (clinicaltrialsregister.eu) - P1/2 | N=516 | Sponsor: GLAXOSMITHKLINE BIOLOGICALS SA

New P1/2 trial • Dermatology • Infectious Disease

A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella and Typhoid Fever (clinicaltrials.gov) - P1/2 | N=155 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease

A study to evaluate safety, reactogenicity, and immune response of GVGH iNTS TCV vaccine against invasive nontyphoidal Salmonella and Typhoid Fever (clinicaltrialsregister.eu) - P1/2 | N=155 | Ongoing | Sponsor: GlaxoSmithKline Biologicals SA

New P1/2 trial • Dermatology • Infectious Disease

A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella and Typhoid Fever (clinicaltrials.gov) - P1/2 | N=155 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P1/2 trial • Infectious Disease