Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LTB-SA7 · 1 trial · 1 indication
Occurrence and severity of solicited local and systemic AEs during 7 days after each dose (i.e., day of vaccination and the 6 subsequent days) in all participants by intervention group.
Occurrence, severity, and relationship to vaccination of unsolicited AEs during 28 days after each dose (i.e., day of injection and the 27 subsequent days) in all participants by intervention group.
Occurrence, severity, and relationship to vaccination of SAEs in all participants during the trial duration by intervention group.
Serum IgG antibody geometric mean titers (GMT) against each of the 7 toxoids present in the LTB-SA7 vaccine in serum samples collected 4 weeks after the 1st vaccination (Visit 4 \[Day 29\]) by intervention group to identify preferred dose(s).
| Arm | Type | Description |
|---|---|---|
| LTB-SA7 low dose, 1 vaccination | EXPERIMENTAL | The candidate toxoid vaccine (LTB-SA7) is administered once, 1 month later participant receives a placebo. |
| LTB-SA7 low dose, 2 vaccinations | EXPERIMENTAL | The candidate toxoid vaccine (LTB-SA7) is administered twice, 1 month apart. |
| LTB-SA7 medium dose, 1 vaccination | EXPERIMENTAL | The candidate toxoid vaccine (LTB-SA7) is administered once, 1 month later participant receives a placebo. |
| LTB-SA7 medium dose, 2 vaccinations | EXPERIMENTAL | The candidate toxoid vaccine (LTB-SA7) is administered twice, 1 month apart. |
| LTB-SA7 high dose, 1 vaccination | EXPERIMENTAL | The candidate toxoid vaccine (LTB-SA7) is administered once, 1 month later participant receives a placebo. |
| LTB-SA7 high dose, 2 vaccinations | EXPERIMENTAL | The candidate toxoid vaccine (LTB-SA7) is administered twice, 1 month apart. |
| Placebo | PLACEBO_COMPARATOR | Participant receives placebo twice, 1 month apart. |
| Name | Type | Description |
|---|---|---|
| LTB-SA7 | BIOLOGICAL | LTB-SA7 is a toxoid based vaccine consisting of five components including seven toxoids formulated with Alhydrogel. |
| Placebo | BIOLOGICAL | Sodium Phosphate with Sodium Chloride |
Inclusion Criteria: 1. Good general health by medical history, laboratory findings and physical examination as judged by the investigator before receiving the first injection. 2. Participant who is willing and able to comply with the requirements of the protocol (e.g., completion of the diary forms...
LTB-SA7 is an investigational vaccine being developed by Eli Lilly and Company for the prevention of Staphylococcus aureus infection. It is a monoclonal antibody-based product and has completed a Phase 1 first-in-human clinical trial. LTB-SA7 is not yet approved for any indication.
LTB-SA7 is being developed for Staphylococcus (S.) aureus infection. The completed Phase 1 trial enrolled healthy adult volunteers, indicating the vaccine is intended for prevention rather than treatment of established infection. No approved uses exist for LTB-SA7 at this time.
LTB-SA7 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the Phase 1 trial evaluating the vaccine in healthy volunteers.
LTB-SA7 has completed a Phase 1 first-in-human clinical trial. It remains an investigational product and has not been approved by the FDA or any other regulatory agency. No later-phase trials are currently active.
LTB-SA7 has been evaluated in one clinical trial, NCT06719219, titled "A First in Human Trial to Assess the Safety and Immunogenicity of LTB-SA7 Vaccine Against Staphylococcus Aureus." The Phase 1 trial was completed, enrolled 129 participants, and was randomized, double-blind, and placebo-controlled.