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

NCT06719219 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2026-08-03

No results posted yet for this study

Summary

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

Conditions

  • Staphylococcus (S.) Aureus Infection

Interventions

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

Sponsors & Collaborators

  • Wellcome Trust

    collaborator OTHER

  • Navy Medical Research Command (NMRC)

    collaborator UNKNOWN

  • DG HERA (kfW)

    collaborator UNKNOWN

  • Germany's Federal Ministry of Education and Research

    collaborator UNKNOWN

  • UK Department of Health and Social Care as part of the Global Antimicrobial Resistance Innovation Fund

    collaborator UNKNOWN

  • Health and Human Services and Biomedical Advanced Research and Development Authority

    collaborator UNKNOWN

  • LimmaTech Biologics AG

    lead INDUSTRY

Principal Investigators

  • Nehkonti Adams, MD · Naval Medical Research Command

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-07
Primary Completion
2026-03-04
Completion
2026-03-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06719219 on ClinicalTrials.gov