CompletedPhase 1

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

United States129 participantsStarted 2025-01-07

Plain-language summary

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

Age range18 Years – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Good general health by medical history, laboratory findings and physical examination as judged by the investigator before receiving the first injection.
✓. Participant who is willing and able to comply with the requirements of the protocol (e.g., completion of the diary forms, return for follow-up visits).
✓. Signed written informed consent obtained from the participant.
✓. Participants between 18-50 years (inclusive) of age at the time of the first injection.
✓. Negative urine pregnancy test for women of childbearing potential (WOCBP).
✓. WOCBP must be willing to use a highly effective method of contraception during the trial.

✕. Health conditions that, in the opinion of the investigator, may interfere with optimal participation in the trial or place the participant at increased risk of adverse events.
✕. Any deviation from the normal range in biochemistry or hematology blood tests clinically significant in the opinion of the investigator, measured at the screening visit.
✕. Clinically significant abnormalities on physical examination.
✕. Suspected or known hypersensitivity (including allergy) to any of the vaccine components or medical equipment whose use is foreseen in this trial.
✕. History of allergy to any vaccine.
✕. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws (e.g., coagulation disorder).
✕. Known or suspected impairment of immunological function e.g., documented Human Immunodeficiency Virus (HIV) infection, asplenia/splenectomy, or history of autoimmune disease or lymphoproliferative disorder.
✕. Positive blood test for HBsAg, HCV, HIV-1/2.

Safety - Solicited local and systemic AEs

Timeframe: During 7 days following each vaccination.

Safety - Unsolicited AEs

Timeframe: During 28 days following each vaccination.

Safety - SAEs

Timeframe: Throughout the study, on average 8 months

Immunogenicity - GMTs of anti-toxoids IgGs in serum at V4

Timeframe: 1 month from the first vaccination.

NCT IDNCT06719219

SponsorLimmaTech Biologics AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-04

Who can participate