At a glance
ClinicalIndex Comparison Record- ✓Healthy males and females aged 18-50 years
- ✓Negative HLA-B27 genetic test (Stage 1 only)
- ✓Female participants of childbearing potential must have negative pregnancy test on day of vaccination and practice adequate contraception for 1 month prior and 1 month after study
- ✓Able and willing to comply with protocol requirements
- ✕Known exposure to S. Typhi or nontyphoidal Salmonella confirmed by blood culture within 3 years prior to enrollment
- ✕Any prior typhoid vaccine (Ty21a, Vi polysaccharide, or TCV) in participant's lifetime
- ✕Any prior investigational iNTS or GMMA vaccines in participant's lifetime
- ✕Immunosuppressive or immunodeficient condition
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1/2a, Observer-blind, Randomized, Controlled, Two-stage, Multi-country Study to Evaluate the Safety, Reactogenicity, and Immune Response of the Trivalent Vaccine Against Invasive Nontyphoidal Salmonella (iNTS) and Typhoid Fever in Healthy European and African Adults
In Brief
A Phase 2 clinical trial evaluating Invasive nontyphoidal Salmonella-typhoid conjugate vaccine (iNTS-TCV) low dose, Invasive nontyphoidal Salmonella-generalized modules for membrane antigens vaccine (iNTS-GMMA) low dose, and 9 other interventions for Salmonella Infections. Completed, enrolled 155 participants across 2 sites in 2 countries.
Detailed Summary
The purpose of this study is to assess the safety, reactogenicity, and immune response induced by the GlaxoSmithKline Biologicals SA (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-typhoid conjugate (iNTS-TCV) candidate vaccine to be administered for the first time in humans. The study intervention will be evaluated in European adults in Stage 1 (a 2-step staggered design) followed by African adults in Stage 2.
Study Details
Timeline
Interventions
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).
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).
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).
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 Group in Stage 1 (Europe) and to participants in iNTS-TCV full dose Group in Stage 2 (Africa).
3 doses of iNTS-GMMA full dose vaccine administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-GMMA + TCV full dose Group in Stage 1 (Europe) and to participants in the iNTS-GMMA + TCV full dose Group in Stage 2 (Africa).
3 doses of TCV full dose vaccine administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-GMMA + TCV full dose Group in Stage 1 (Europe) and to participants in the iNTS-GMMA + TCV full dose Group in Stage 2 (Africa).
1 dose of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine administered intramuscularly at Day 1 to participants in the Control Group in Stage 2 (Africa).
1 dose of GSK's Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine administered intramuscularly at Day 57 to participants in the Control Group in Stage 2 (Africa).
1 dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine administered intramuscularly at Day 169 to participants in the Control Group in Stage 2 (Africa).
3 doses of Placebo administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the Placebo Group in Stage 1 (Europe).
3 doses of saline solution administered intramuscularly at Day 1, Day 57, and Day 169 to the participants.