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

NCT06719219 | Completed Phase 1 DMC FDA Drug

• 5 other identifiers: LTBSA70175A50122C00028WT224842Agmt dtd 2/28/2023Agmt dtd 1/30/2023
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Staphylococcus (S.) Aureus Infection

Keywords

Staphylococcus aureus vaccine; skin and soft tissue infection vaccine; staphylococcus aureus recurrence

Outcome Measures

Primary Outcomes (4)

• Safety - Solicited local and systemic AEs

  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.

  During 7 days following each vaccination.

• Safety - Unsolicited AEs

  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.

  During 28 days following each vaccination.

• Safety - SAEs

  Occurrence, severity, and relationship to vaccination of SAEs in all participants during the trial duration by intervention group.

  Throughout the study, on average 8 months

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

  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).

  1 month from the first vaccination.

Secondary Outcomes (3)

• Immunogenicity - GMTs of anti-toxoid IgGs in serum at V3, V5 and V6

  From 1 week after first vaccination till Day 57 (Visit 6).

• Immunogenicity - GMFR of anti-toxoid IgGs in serum at V2-V6.

  Between baseline on Visit 2 (Day 1) until 4 weeks post 2nd vaccination on Visit 6 (Day 57).

• Immunogenicity - Total IgGs titer in serum

  Between baseline on Visit 2 (Day 1) until 4 weeks post 2nd vaccination on Visit 6 (Day 57).

Study Arms (7)

LTB-SA7 low dose, 1 vaccination

EXPERIMENTAL

The candidate toxoid vaccine (LTB-SA7) is administered once, 1 month later participant receives a placebo.

Biological: LTB-SA7

LTB-SA7 low dose, 2 vaccinations

EXPERIMENTAL

The candidate toxoid vaccine (LTB-SA7) is administered twice, 1 month apart.

Biological: LTB-SA7

LTB-SA7 medium dose, 1 vaccination

EXPERIMENTAL

The candidate toxoid vaccine (LTB-SA7) is administered once, 1 month later participant receives a placebo.

Biological: LTB-SA7

LTB-SA7 medium dose, 2 vaccinations

EXPERIMENTAL

The candidate toxoid vaccine (LTB-SA7) is administered twice, 1 month apart.

Biological: LTB-SA7

LTB-SA7 high dose, 1 vaccination

EXPERIMENTAL

The candidate toxoid vaccine (LTB-SA7) is administered once, 1 month later participant receives a placebo.

Biological: LTB-SA7

LTB-SA7 high dose, 2 vaccinations

EXPERIMENTAL

The candidate toxoid vaccine (LTB-SA7) is administered twice, 1 month apart.

Biological: LTB-SA7

Placebo

PLACEBO COMPARATOR

Participant receives placebo twice, 1 month apart.

Biological: Placebo

Interventions

LTB-SA7 BIOLOGICAL

LTB-SA7 is a toxoid based vaccine consisting of five components including seven toxoids formulated with Alhydrogel.

LTB-SA7 high dose, 1 vaccination; LTB-SA7 high dose, 2 vaccinations; LTB-SA7 low dose, 1 vaccination; LTB-SA7 low dose, 2 vaccinations; LTB-SA7 medium dose, 1 vaccination; LTB-SA7 medium dose, 2 vaccinations

Placebo BIOLOGICAL

Sodium Phosphate with Sodium Chloride

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• History of systemic administration of immunosuppressive drugs, i.e., corticosteroids, (PO/IV/IM) within the last month prior to vaccination or for more than 14 consecutive days within 3 months prior to vaccination, until the last blood sampling visit (i.e., prednisone or equivalent ≥20 mg/day). Inhaled and topical steroids are allowed.
• Administration of antineoplastic and immune-modulating agents or chemotherapy within 3 months prior to vaccination.
• Planned or actual administration of any licensed vaccine within 14 days prior to each vaccination and 30 days after each vaccination. Note: In case an emergency mass vaccination for an unforeseen public health threat (e.g.: a pandemic) is organized by the public health authorities, the time period described above can be reduced, if necessary, for that vaccine provided it is licensed or authorized and used according to the local governmental recommendations and provided a written approval of the Sponsor is obtained.
• Concurrently participating in another clinical trial, at any time during the trial period, in which the participant has been or will be exposed to an investigational or a non-investigational interventional vaccine/ product (pharmaceutical product).
• Body Mass Index (BMI) ≤19 or ≥35
• History of any chronic or progressive disease that according to judgment of the investigator could interfere with the trial outcomes or pose a threat to the participant's health.
• Received an investigational or non-registered product (medicinal drug or vaccine), other than the trial vaccine within 3 months prior to 1st administration of trial vaccine, or planned use during the trial period.

Sponsors & Collaborators

• LimmaTech Biologics AG: lead
• Biomedical Advanced Research and Development Authority: collaborator
• Wellcome Trust: collaborator
• Navy Medical Research Command (NMRC): collaborator

Study Sites (1)

Naval Medical Research Command Clinical Trial Center

Bethesda, Maryland, 20889, United States

Location

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Study Officials

• Nehkonti Adams, MD

  Naval Medical Research Command

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 5, 2024
• Study Start: January 7, 2025
• Primary Completion: March 4, 2026
• Study Completion: March 4, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)