A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella and Typhoid Fever

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

155

Participants

Timeline

Start Date

September 13, 2022

Primary Completion Date

December 18, 2024

Study Completion Date

December 18, 2024

Conditions
Salmonella Infections
Interventions
BIOLOGICAL

Invasive nontyphoidal Salmonella-typhoid conjugate vaccine (iNTS-TCV) low dose

3 doses of iNTS-TCV low dose vaccine administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-TCV low dose Group in Stage 1 (Europe).

BIOLOGICAL

Invasive nontyphoidal Salmonella-generalized modules for membrane antigens vaccine (iNTS-GMMA) low dose

3 doses of iNTS-GMMA low dose vaccine administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-GMMA and TCV low doses Group in Stage 1 (Europe).

BIOLOGICAL

Typhoid conjugate vaccine (TCV) low dose

3 doses of TCV low dose vaccine administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-GMMA and TCV low doses Group in Stage 1 (Europe).

BIOLOGICAL

Invasive nontyphoidal Salmonella-typhoid conjugate vaccine (iNTS-TCV) full dose

3 doses of iNTS-TCV full dose vaccine administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-TCV full dose\_1 Group in Stage 1 (Europe) and to participants in iNTS-TCV full dose\_2 Group in Stage 2 (Africa).

BIOLOGICAL

Invasive nontyphoidal Salmonella-generalized modules for membrane antigens vaccine (iNTS-GMMA) full dose

3 doses of iNTS-GMMA full dose vaccine administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-GMMA and TCV full doses\_1 Group in Stage 1 (Europe) and to participants in the iNTS-GMMA and TCV full doses\_2 Group in Stage 2 (Africa).

BIOLOGICAL

Typhoid conjugate vaccine (TCV) full dose

3 doses of TCV full dose vaccine administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-GMMA and TCV full doses\_1 Group in Stage 1 (Europe) and to participants in the iNTS-GMMA and TCV full doses\_2 Group in Stage 2 (Africa).

BIOLOGICAL

GSK's Meningococcal A, C, Y and W-135 conjugate vaccine

1 dose of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine administered intramuscularly at Day 1 to participants in the Control\_Stage 2 Group in Stage 2 (Africa).

COMBINATION_PRODUCT

GSK's Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine

1 dose of GSK's Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine administered intramuscularly at Day 57 to participants in the Control\_Stage 2 Group in Stage 2 (Africa).

COMBINATION_PRODUCT

Sanofi Pasteur's Typhoid Vi polysaccharide vaccine

1 dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine administered intramuscularly at Day 169 to participants in the Control\_Stage 2 Group in Stage 2 (Africa).

DRUG

Placebo

3 doses of Placebo administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the Placebo\_Step 1 and Placebo\_Step 2 in Stage 1 (Europe).

OTHER

Saline

3 doses of saline solution administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-TCV low dose, Placebo\_Step 1, iNTS-TCV full dose\_1, Placebo\_Step 2 groups in Stage 1 (Europe) and to participants in iNTS-TCV full dose\_2 and Control\_Stage 2 groups in Stage 2 (Africa).

Trial Locations (2)

2650

RECRUITING

GSK Investigational Site, Edegem

Unknown

RECRUITING

GSK Investigational Site, Blantyre

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Biomedical Advanced Research and Development Authority

FED

collaborator

Wellcome Trust

OTHER

collaborator

Global Antimicrobial Resistance Innovation Fund-(GAMRIF)

UNKNOWN

collaborator

Bill and Melinda Gates Foundation

OTHER

lead

GlaxoSmithKline

INDUSTRY

NCT05480800 - A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella and Typhoid Fever | Biotech Hunter | Biotech Hunter