In this study, the candidate vaccine LTB-SA7 will be tested for safety and immunogenicity in healthy adults.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
129
Naval Medical Research Command Clinical Trial Center
Bethesda, Maryland, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 1 month from the first vaccination.
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 \[Day 57\]).
Time frame: From 1 week after first vaccination till Day 57 (Visit 6).
Immunogenicity - GMFR of anti-toxoid IgGs in serum at V2-V6.
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Serum IgG antibody geometric mean fold ratio (GMFR) vs. baseline.
Time frame: Between baseline on Visit 2 (Day 1) until 4 weeks post 2nd vaccination on Visit 6 (Day 57).
Immunogenicity - Total IgGs titer in serum
Percentage of participants with ≥ 2-fold ≥ 4-fold, and ≥ 8-fold IgG titer increase vs. baseline.
Time frame: Between baseline on Visit 2 (Day 1) until 4 weeks post 2nd vaccination on Visit 6 (Day 57).