Staphylococcus (S.) Aureus Infection
Conditions
Keywords
Staphylococcus aureus vaccine, skin and soft tissue infection vaccine, staphylococcus aureus recurrence
Brief summary
In this study, the candidate vaccine LTB-SA7 will be tested for safety and immunogenicity in healthy adults.
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.
Interventions
BIOLOGICALLTB-SA7
LTB-SA7 is a toxoid based vaccine consisting of five components including seven toxoids formulated with Alhydrogel.
BIOLOGICALPlacebo
Sodium Phosphate with Sodium Chloride
Sponsors
LimmaTech Biologics AG
Wellcome Trust
Navy Medical Research Command (NMRC)
DG HERA (kfW)
Germany's Federal Ministry of Education and Research
UK Department of Health and Social Care as part of the Global Antimicrobial Resistance Innovation Fund
Health and Human Services and Biomedical Advanced Research and Development Authority
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Good general health by medical history, laboratory findings and physical examination as judged by the investigator before receiving the first injection. 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
1. 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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety - Solicited local and systemic AEs | During 7 days following each vaccination. | 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. |
| Safety - Unsolicited AEs | During 28 days following each vaccination. | 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. |
| Safety - SAEs | Throughout the study, on average 8 months | Occurrence, severity, and relationship to vaccination of SAEs in all participants during the trial duration by intervention group. |
| Immunogenicity - GMTs of anti-toxoids IgGs in serum at V4 | 1 month from the first vaccination. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity - GMTs of anti-toxoid IgGs in serum at V3, V5 and V6 | From 1 week after first vaccination till Day 57 (Visit 6). | 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 \[Day 57\]). |
| 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). | Serum IgG antibody geometric mean fold ratio (GMFR) vs. baseline. |
| Immunogenicity - Total IgGs titer in serum | Between baseline on Visit 2 (Day 1) until 4 weeks post 2nd vaccination on Visit 6 (Day 57). | Percentage of participants with ≥ 2-fold ≥ 4-fold, and ≥ 8-fold IgG titer increase vs. baseline. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNehkonti Adams, MD
Naval Medical Research Command
Outcome results
None listed