Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Shigella4V2 · 2 trials · 1 indication
Safety and tolerability of the candidate vaccine Shigella4V2 as determined by occurrence, severity, and relationship of solicited AEs
Safety and tolerability of the candidate vaccine Shigella4V2 as determined by occurrence, severity, and relationship of unsolicited AEs
Safety and tolerability of the candidate vaccine Shigella4V2 as determined by occurrence, severity, and relationship of SAEs
Evaluation of geometric mean titers (GMT) and geometric mean ratios between baseline and 1-month post 2nd vaccination (GMR vs baseline) for serum IgG against the four Shigella serotypes included in the Shigella4V2 bioconjugate.
The number of challenged participants with shigellosis post-challenge during the inpatient period that received vaccine compared to participants who received placebo. Shigellosis is defined as: 1. Severe diarrhea; OR 2. Moderate diarrhea AND \[fever OR ≥ 1 at least moderate constitutional/enteric symptoms OR ≥ 2 episodes of vomiting in 24 h\]; OR 3. Dysentery AND \[fever OR ≥ 1 at least moderate constitutional/enteric symptoms OR ≥ 2 episodes of vomiting in 24 h\]
| Arm | Type | Description |
|---|---|---|
| low dose | EXPERIMENTAL | Participants receive 2 low-dose administrations of the investigational product |
| high dose | EXPERIMENTAL | Participants receive 2 high-dose administrations of the investigational product |
| Control | OTHER | Participants receive 2 administrations of MenACWY |
| Shigella4V2 High dose | EXPERIMENTAL | 1 injection of high dose Shigella4V2 and 1 injection of low dose Shigella4V2 will be injected intramuscularly in the deltoid muscle |
| Shigella4V2 Low dose | EXPERIMENTAL | 2 injections of low dose of Shigella4V2 will be injected intramuscularly in the deltoid muscle |
| Placebo | PLACEBO_COMPARATOR | 2 injections of PBS will be injected intramuscularly in the deltoid muscle |
| Name | Type | Description |
|---|---|---|
| Shigella4V2 | BIOLOGICAL | Adjuvanted Shigella4V2 administrated at 2 different doses: low and high. |
| MenACWY | BIOLOGICAL | Control vaccine |
| Placebo | BIOLOGICAL | Phosphate-buffered saline |
Inclusion Criteria: * Female or male aged 9 months (± 1 month) old at the time of the first vaccination. * Born full-term (i.e., after a gestation period of 37 to less than 42 full weeks). * Healthy by medical history, laboratory findings and physical examination before entering into the study (Par...
Shigella4V2 is an investigational vaccine being developed for shigellosis, a diarrheal disease caused by Shigella bacteria. It is a tetravalent bioconjugate vaccine, meaning it combines multiple Shigella serotype components into a single formulation. Eli Lilly and Company is developing it, and it has completed Phase 2 clinical testing.
Shigella4V2 is being developed to prevent shigellosis, the diarrheal illness caused by Shigella infection. Its clinical program has studied the vaccine in healthy adult volunteers in the United States and in infants in Kenya, reflecting an intended use across both adult and pediatric populations in regions where shigellosis is a concern.
Shigella4V2 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the vaccine's clinical program, which includes human challenge and infant immunogenicity studies conducted in the United States and Kenya.
Shigella4V2 has completed Phase 2 clinical development. Two Phase 2 trials have been conducted and both are listed as completed, with no active trials currently ongoing. The studies together enrolled 207 participants. Shigella4V2 is an investigational vaccine and has not been approved by the FDA.
Shigella4V2 has been evaluated in two completed Phase 2 trials. NCT06615375 was a human challenge study assessing protection of the Shigella tetravalent bioconjugate vaccine, enrolling 97 healthy adult volunteers in the United States. NCT06523231 evaluated safety and immunogenicity in 110 infants from 8 months of age in Kenya.
Shigella4V2 is a tetravalent bioconjugate vaccine designed to protect against shigellosis. Bioconjugate vaccines link polysaccharide antigens to carrier proteins to generate a stronger immune response. The tetravalent formulation covers multiple Shigella serotypes in one product, and the program has assessed immune response and protection in both adult challenge and infant studies.