A First in Human Trial to Assess the Safety and Immunogenicity of LTB-SA7 Vaccine Against Staphylococcus Aureus.
NCT ID: NCT06719219
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
129 participants
INTERVENTIONAL
2025-01-07
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
QUADRUPLE
Study Groups
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LTB-SA7 low dose, 1 vaccination
The candidate toxoid vaccine (LTB-SA7) is administered once, 1 month later participant receives a placebo.
LTB-SA7
LTB-SA7 is a toxoid based vaccine consisting of five components including seven toxoids formulated with Alhydrogel.
LTB-SA7 low dose, 2 vaccinations
The candidate toxoid vaccine (LTB-SA7) is administered twice, 1 month apart.
LTB-SA7
LTB-SA7 is a toxoid based vaccine consisting of five components including seven toxoids formulated with Alhydrogel.
LTB-SA7 medium dose, 1 vaccination
The candidate toxoid vaccine (LTB-SA7) is administered once, 1 month later participant receives a placebo.
LTB-SA7
LTB-SA7 is a toxoid based vaccine consisting of five components including seven toxoids formulated with Alhydrogel.
LTB-SA7 medium dose, 2 vaccinations
The candidate toxoid vaccine (LTB-SA7) is administered twice, 1 month apart.
LTB-SA7
LTB-SA7 is a toxoid based vaccine consisting of five components including seven toxoids formulated with Alhydrogel.
LTB-SA7 high dose, 1 vaccination
The candidate toxoid vaccine (LTB-SA7) is administered once, 1 month later participant receives a placebo.
LTB-SA7
LTB-SA7 is a toxoid based vaccine consisting of five components including seven toxoids formulated with Alhydrogel.
LTB-SA7 high dose, 2 vaccinations
The candidate toxoid vaccine (LTB-SA7) is administered twice, 1 month apart.
LTB-SA7
LTB-SA7 is a toxoid based vaccine consisting of five components including seven toxoids formulated with Alhydrogel.
Placebo
Participant receives placebo twice, 1 month apart.
Placebo
Sodium Phosphate with Sodium Chloride
Interventions
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LTB-SA7
LTB-SA7 is a toxoid based vaccine consisting of five components including seven toxoids formulated with Alhydrogel.
Placebo
Sodium Phosphate with Sodium Chloride
Eligibility Criteria
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Inclusion Criteria
2. 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).
3. Signed written informed consent obtained from the participant.
4. Participants between 18-50 years (inclusive) of age at the time of the first injection.
5. Negative urine pregnancy test for women of childbearing potential (WOCBP).
6. WOCBP must be willing to use a highly effective method of contraception during the trial.
Exclusion Criteria
2. 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.
3. Clinically significant abnormalities on physical examination.
4. Suspected or known hypersensitivity (including allergy) to any of the vaccine components or medical equipment whose use is foreseen in this trial.
5. History of allergy to any vaccine.
6. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws (e.g., coagulation disorder).
7. 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.
8. Positive blood test for HBsAg, HCV, HIV-1/2.
9. 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.
10. Administration of antineoplastic and immune-modulating agents or chemotherapy within 3 months prior to vaccination.
11. 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.
12. 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).
13. Body Mass Index (BMI) ≤19 or ≥35
14. 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.
15. 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.
16. Administration of immunoglobulin and/or any blood products within the three months preceding the first dose of trial vaccine.
17. 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.
18. Use of any systemic antibiotic therapy within 1 week preceding each vaccination.
19. Participants with an elective surgical intervention, planned during the trial period until 1 month after 2nd vaccination.
20. Female participants lactating, pregnant, or intending to become pregnant as reported by the participant.
18 Years
50 Years
ALL
Yes
Sponsors
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Biomedical Advanced Research and Development Authority
FED
Wellcome Trust
OTHER
Navy Medical Research Command (NMRC)
UNKNOWN
LimmaTech Biologics AG
INDUSTRY
Responsible Party
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Principal Investigators
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Nehkonti Adams, MD
Role: PRINCIPAL_INVESTIGATOR
Naval Medical Research Command
Locations
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Naval Medical Research Command Clinical Trial Center
Bethesda, Maryland, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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75A50122C00028
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
WT224842
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Agmt dtd 2/28/2023
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Agmt dtd 1/30/2023
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
LTBSA701
Identifier Type: -
Identifier Source: org_study_id
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