The main goal of this trial is to evaluate the safety and immunogenicity of the candidate N. gonorrhoeae vaccine, LTB-NG6.
LTB-NG6 is a vaccine including 6 N. gonorrhoeae antigens. During the study, healthy adults will be randomized to receive 1 of 5 different vaccine doses, or a placebo. Participants will receive a 2-dose schedule.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
142
LTB-NG6 administrated at 5 different doses
sodium chloride 0.9% used as a diluent in LTB-NG6 and as a placebo
Nuvisan GmbH
Neu-Ulm, Bavaria, Germany
RECRUITINGSafety: local and systemic AEs (7-days-post)
To evaluate the safety and tolerability of vaccination with LTB-NG6 in healthy participants after each injection in vaccinees vs. placebo and by dose: \- Percentage of participants reporting each solicited local and systemic AE during the seven days after each injection (i.e., day of injection and the six subsequent days).
Time frame: During 7 days following each injection
Safety: any events after each injection
To evaluate the safety and tolerability of vaccination with LTB-NG6 in healthy participants after each injection in vaccinees vs. placebo and by dose: * Percentage of participants reporting any adverse event (AE) following each injection * Percentage of participants reporting each severity level (Grade 1-4) of solicited local, systemic and unsolicited AEs following each injection
Time frame: During 28 days following each injection
Safety: unsolicited AEs, SAEs, MAAEs
To evaluate the safety and tolerability of vaccination with LTB-NG6 in healthy participants after each injection in vaccinees vs. placebo and by dose: * Percentage of participants with unsolicited AEs. * Percentage of participants with serious adverse events (SAEs) following each injection. * Percentage of participants with medically attended adverse events (MAAEs) following each injection.
Time frame: Through study completion, an average of 18 months
Immunogenicity - primary IgGs GMT
To evaluate the immunogenicity of different doses of LTB-NG6 to identify the preferred dose(s). Serum IgG geometric mean titers (GMTs) against each of the N. gonorrhoeae antigens included in LTB-NG6 summarized by treatment group
Time frame: At 28 days after the second injection
Immunogenicity - secondary IgGs
To expand the evaluation of the immunogenicity of LTB-NG6 for each treatment group at baseline and 28 days after each injection for each of the antigens included in LTB-NG6: * Serum IgG GMTs (except for primary endpoint) * Serum IgG geometric mean fold ratio (GMFR) * Percentage of participants with ≥ 4-fold increase in serum IgG titer.
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Time frame: At baseline and 28 days after the second injection
Safety: AEs relatedness to injection, vaccine vs. placebo
To further evaluate the safety of LTB-NG6. Percentage of participants with solicited local, systemic, unsolicited AEs, and SAEs according to relatedness to injection, in vaccinees vs. placebo.
Time frame: Through study completion, an average of 18 months
Safety: lab abnormalities
To evaluate changes in hematological and blood chemistry parameters following each injection. Percentage of participants with hematological and blood chemistry laboratory abnormalities at 7 days after each injection compared to baseline in vaccinees vs. placebo.
Time frame: At baseline and 7 days after each injection