A randomized, double-blinded, positive-controlled clinical trial will be conducted to observe the safety and immunogenicity of DX-104 in adults 18 to 50 years of age.
A total of 30 healthy participants will be enrolled and randomized (2:1) to receive DX-104 or Bexsero® (multicomponent meningococcal group B vaccine). Participants in both the DX-104 and Bexsero® groups will receive three doses of intramuscular vaccination at Months 0, 1, and 6. After all participants have completed the 6-month safety and immunogenicity observations following full vaccination, the trial will be concluded.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
30
Intramuscular injection; 0.5ml/pre-filled syringe. Administer the vaccine according to the 0, 1, 6-month schedule.
Intramuscular injection; 0.5ml/vial. Administer the vaccine according to the 0, 1, 6-month schedule.
Linear Early Phase Limited
Perth, Western Australia, Australia
To assess the overall safety of DX-104
1. The incidence and severity of any AEs within 30 days after each vaccination. 2. The incidence and severity of any AEs within 30 minutes after each vaccination. 3. The incidence and severity of any solicited local and systemic AEs within 7 days after each vaccination. 4. The incidence and severity of any unsolicited AEs within 30 days after each vaccination. 5. The occurrence of clinically significant laboratory abnormalities on Day 3 after each vaccination. 6. The incidence of any serious adverse events (SAEs) from the first vaccination until 6 months after the last vaccination.
Time frame: Through study completion, an average of 1 year.
To evaluate the immunogenicity of DX-104
Geometric mean titers (GMTs) of serum bactericidal antibody against meningococcal B strains, as measured by serum bactericidal assays using human complement (hSBA), at Day 30 following each vaccination and at 6 months after the last vaccination.
Time frame: Through study completion, an average of 1 year.
To evaluate the immunogenicity of DX-104
Geometric mean-fold rise (GMFR) relative to baseline of serum bactericidal antibody against meningococcal B strains, as measured by serum bactericidal assays using human complement (hSBA), at Day 30 following each vaccination and at 6 months after the last vaccination.
Time frame: Through study completion, an average of 1 year.
To evaluate the immunogenicity of DX-104
Seroconversion rate (SCR) of serum bactericidal antibody against meningococcal B strains, as measured by serum bactericidal assays using human complement (hSBA), at Day 30 following each vaccination and at 6 months after the last vaccination.
Time frame: Through study completion, an average of 1 year.
To evaluate the immunogenicity of DX-104
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Geometric mean titers (GMTs) of Immunoglobulin G (IgG) against meningococcal B strains, as measured by ELISA, at Day 30 following each vaccination and at 6 months after the last vaccination.
Time frame: Through study completion, an average of 1 year.
To evaluate the immunogenicity of DX-104
Geometric mean-fold rise (GMFR) relative to baseline of Immunoglobulin G (IgG) against meningococcal B strains, as measured by ELISA, at Day 30 following each vaccination and at 6 months after the last vaccination.
Time frame: Through study completion, an average of 1 year.
To evaluate the immunogenicity of DX-104
Seroconversion rate (SCR) of Immunoglobulin G (IgG) against meningococcal B strains, as measured by ELISA, at Day 30 following each vaccination and at 6 months after the last vaccination.
Time frame: Through study completion, an average of 1 year.