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Staphylococcus (S.) Aureus InfectionPhase 1LTBSA701NCT06719219

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

A Phase 1 study testing LTB-SA7 in people with Staphylococcus (S.) Aureus Infection, run by LimmaTech Biologics AG at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Staphylococcus (S.) Aureus Infection
What is being tested?
LTB-SA7
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
129 participants
Where
1 siteUnited States
Study dates
7 Jan 2025to 4 Mar 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 20Show fewer
  • 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.
  • Administration of immunoglobulin and/or any blood products within the three months preceding the first dose of trial vaccine.
  • Blood donation equal or greater to 500 mL of blood drawn within 3 months preceding the first or second vaccination or planned during the trial period as reported by the participant.
  • Use of any systemic antibiotic therapy within 1 week preceding each vaccination.
  • Participants with an elective surgical intervention, planned during the trial period until 1 month after 2nd vaccination.
  • Female participants lactating, pregnant, or intending to become pregnant as reported by the participant.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Naval Medical Research Command Clinical Trial Center

    Bethesda, Maryland, 20889

Other trials in United States

About this study

Official title: 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.

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

Read the 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.

Being tested
LTB-SA7, Placebo
Keywords
Staphylococcus aureus vaccine, skin and soft tissue infection vaccine, staphylococcus aureus recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LTB-SA7Biological

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

  • PlaceboBiological

    Sodium Phosphate with Sodium Chloride

Study groups in NCT06719219
Study groupRoleWhat they receive
LTB-SA7 low dose, 1 vaccinationExperimentalThe candidate toxoid vaccine (LTB-SA7) is administered once, 1 month later participant receives a placebo.
Receives: Biological: LTB-SA7
LTB-SA7 low dose, 2 vaccinationsExperimentalThe candidate toxoid vaccine (LTB-SA7) is administered twice, 1 month apart.
Receives: Biological: LTB-SA7
LTB-SA7 medium dose, 1 vaccinationExperimentalThe candidate toxoid vaccine (LTB-SA7) is administered once, 1 month later participant receives a placebo.
Receives: Biological: LTB-SA7
LTB-SA7 medium dose, 2 vaccinationsExperimentalThe candidate toxoid vaccine (LTB-SA7) is administered twice, 1 month apart.
Receives: Biological: LTB-SA7
LTB-SA7 high dose, 1 vaccinationExperimentalThe candidate toxoid vaccine (LTB-SA7) is administered once, 1 month later participant receives a placebo.
Receives: Biological: LTB-SA7
LTB-SA7 high dose, 2 vaccinationsExperimentalThe candidate toxoid vaccine (LTB-SA7) is administered twice, 1 month apart.
Receives: Biological: LTB-SA7
PlaceboPlacebo comparatorParticipant receives placebo twice, 1 month apart.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: During 7 days following each vaccination.

  2. 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.

    Measured: During 28 days following each vaccination.

  3. Safety - SAEs

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

    Measured: Throughout the study, on average 8 months

  4. 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).

    Measured: 1 month from the first vaccination.

Secondary outcomes (3)

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

    Serum IgG antibody geometric mean titers (GMT) against each of the 7 toxoids present in the LTB-SA7 vaccine in samples collected 1 week after 1st and 2nd vaccination and 4 weeks after 1st and 2nd vaccination (Visit 3 [Day 8], Visit 5 [Day 36], and Visit 6 [Day 57]).

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

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

    Serum IgG antibody geometric mean fold ratio (GMFR) vs. baseline.

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

  3. Immunogenicity - Total IgGs titer in serum

    Percentage of participants with ≥ 2-fold ≥ 4-fold, and ≥ 8-fold IgG titer increase vs. baseline.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2024
  2. Study start7 Jan 2025
  3. Primary completion4 Mar 2026
  4. Study completion4 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06719219
Sponsor's protocol ID
LTBSA701
Other IDs
75A50122C00028, WT224842, Agmt dtd 2/28/2023, Agmt dtd 1/30/2023, CP-CA 25-79
Acronym
LTBSA701
Status last verified
Mar 2026
First submitted
27 Nov 2024
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schoergenhofer C, Gelbenegger G, Hasanacevic D, Schoner L, Steiner MM, Firbas C, Buchtele N, Derhaschnig U, Tanzmann A, Model N, Larcher-Senn J, Drost M, Eibl MM, Roetzer A, Jilma B. A randomized, double-blind study on the safety and immunogenicity of rTSST-1 variant vaccine: phase 2 results. EClinicalMedicine. 2024 Jan 5;67:102404. doi: 10.1016/j.eclinm.2023.102404. eCollection 2024 Jan.

    PubMed 38274114

  • Rajagopalan G, Iijima K, Singh M, Kita H, Patel R, David CS. Intranasal exposure to bacterial superantigens induces airway inflammation in HLA class II transgenic mice. Infect Immun. 2006 Feb;74(2):1284-96. doi: 10.1128/IAI.74.2.1284-1296.2006.

    PubMed 16428778

  • Nizet V. Understanding how leading bacterial pathogens subvert innate immunity to reveal novel therapeutic targets. J Allergy Clin Immunol. 2007 Jul;120(1):13-22. doi: 10.1016/j.jaci.2007.06.005.

    PubMed 17606031

  • Tattevin P, Schwartz BS, Graber CJ, Volinski J, Bhukhen A, Bhukhen A, Mai TT, Vo NH, Dang DN, Phan TH, Basuino L, Perdreau-Remington F, Chambers HF, Diep BA. Concurrent epidemics of skin and soft tissue infection and bloodstream infection due to community-associated methicillin-resistant Staphylococcus aureus. Clin Infect Dis. 2012 Sep;55(6):781-8. doi: 10.1093/cid/cis527. Epub 2012 Jun 5.

    PubMed 22670044

  • Tong SY, Davis JS, Eichenberger E, Holland TL, Fowler VG Jr. Staphylococcus aureus infections: epidemiology, pathophysiology, clinical manifestations, and management. Clin Microbiol Rev. 2015 Jul;28(3):603-61. doi: 10.1128/CMR.00134-14.

    PubMed 26016486

  • Tran VG, Venkatasubramaniam A, Adhikari RP, Krishnan S, Wang X, Le VTM, Le HN, Vu TTT, Schneider-Smith E, Aman MJ, Diep BA. Efficacy of Active Immunization With Attenuated alpha-Hemolysin and Panton-Valentine Leukocidin in a Rabbit Model of Staphylococcus aureus Necrotizing Pneumonia. J Infect Dis. 2020 Jan 2;221(2):267-275. doi: 10.1093/infdis/jiz437.

    PubMed 31504652

  • Tree JA, Hall G, Rees P, Vipond J, Funnell SG, Roberts AD. Repeated high-dose (5 x 10(8) TCID50) toxicity study of a third generation smallpox vaccine (IMVAMUNE) in New Zealand white rabbits. Hum Vaccin Immunother. 2016 Jul 2;12(7):1795-801. doi: 10.1080/21645515.2015.1134070.

    PubMed 26836234

  • Tristan A, Ferry T, Durand G, Dauwalder O, Bes M, Lina G, Vandenesch F, Etienne J. Virulence determinants in community and hospital meticillin-resistant Staphylococcus aureus. J Hosp Infect. 2007 Jun;65 Suppl 2:105-9. doi: 10.1016/S0195-6701(07)60025-5.

    PubMed 17540252

  • Venkatasubramaniam A, Adhikari RP, Kort T, Liao GC, Conley S, Abaandou L, Kailasan S, Onodera Y, Krishnan S, Djagbare DM, Holtsberg FW, Karauzum H, Aman MJ. TBA225, a fusion toxoid vaccine for protection and broad neutralization of staphylococcal superantigens. Sci Rep. 2019 Mar 1;9(1):3279. doi: 10.1038/s41598-019-39890-z.

    PubMed 30824769

  • Venkatasubramaniam A, Liao G, Cho E, Adhikari RP, Kort T, Holtsberg FW, Elsass KE, Kobs DJ, Rudge TL Jr, Kauffman KD, Lora NE, Barber DL, Aman MJ, Karauzum H. Safety and Immunogenicity of a 4-Component Toxoid-Based Staphylococcus aureus Vaccine in Rhesus Macaques. Front Immunol. 2021 Feb 25;12:621754. doi: 10.3389/fimmu.2021.621754. eCollection 2021.

    PubMed 33717122

  • Verreault D, Ennis J, Whaley K, Killeen SZ, Karauzum H, Aman MJ, Holtsberg R, Doyle-Meyers L, Didier PJ, Zeitlin L, Roy CJ. Effective Treatment of Staphylococcal Enterotoxin B Aerosol Intoxication in Rhesus Macaques by Using Two Parenterally Administered High-Affinity Monoclonal Antibodies. Antimicrob Agents Chemother. 2019 Apr 25;63(5):e02049-18. doi: 10.1128/AAC.02049-18. Print 2019 May.

    PubMed 30782986

  • Voyich JM, Otto M, Mathema B, Braughton KR, Whitney AR, Welty D, Long RD, Dorward DW, Gardner DJ, Lina G, Kreiswirth BN, DeLeo FR. Is Panton-Valentine leukocidin the major virulence determinant in community-associated methicillin-resistant Staphylococcus aureus disease? J Infect Dis. 2006 Dec 15;194(12):1761-70. doi: 10.1086/509506. Epub 2006 Nov 2.

    PubMed 17109350

  • Wang Y, Mukherjee I, Venkatasubramaniam A, Dikeman D, Orlando N, Zhang J, Ortines R, Mednikov M, Sherchand SP, Kanipakala T, Le T, Shukla S, Ketner M, Adhikari RP, Karauzum H, Aman MJ, Archer NK. Dry and liquid formulations of IBT-V02, a novel multi-component toxoid vaccine, are effective against Staphylococcus aureus isolates from low-to-middle income countries. Front Immunol. 2024 Apr 3;15:1373367. doi: 10.3389/fimmu.2024.1373367. eCollection 2024.

    PubMed 38633244

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LTB-SA7 in people with Staphylococcus (S.) Aureus Infection, run by LimmaTech Biologics AG at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety - Solicited local and systemic AEs (time frame: During 7 days following each vaccination.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06719219, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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