NCT06719219

A First in Human Trial to Assess the Safety and Immunogenicity of LTB-SA7 Vaccine Against Staphylococcus Aureus.

A Phase I, Randomized, Double-Blinded and Controlled Trial to Evaluate Safety and Immunogenicity of an Investigational Multicomponent Staphylococcus Aureus Toxoid Vaccine (LTB-SA7) in Healthy Adults.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: LimmaTech Biologics AG · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

In this study, the candidate vaccine LTB-SA7 will be tested for safety and immunogenicity in healthy adults.

Detailed description

LTB-SA7 is a candidate vaccine designed to induce immune response against toxins produced by Staphylococcus aureus. During the study, healthy adults will be randomized to receive one out of three different vaccine doses (starting with the group receiving the lowest dose), or a placebo. Participants will receive 2 injections, either two with candidate vaccine, 1 vaccine and 1 placebo, or 2 times placebo.

Conditions

• Staphylococcus (S.) Aureus Infection

Interventions

Type	Name	Description
BIOLOGICAL	LTB-SA7	LTB-SA7 is a toxoid based vaccine consisting of five components including seven toxoids formulated with Alhydrogel.
BIOLOGICAL	Placebo	Sodium Phosphate with Sodium Chloride

Timeline

• Start date: 2025-01-07
• Primary completion: 2026-03-04
• Completion: 2026-03-04
• First posted: 2024-12-05
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study