GEN-004 is a combination of 3 conserved proteins from Streptococcus pneumoniae. This is a randomized, double-blind, placebo-controlled, dose escalation study. Eligible subjects (male and non-pregnant female) will be assigned sequentially to 1 of 3 dose cohorts and randomized in a 3:1:1 ratio to receive GEN-004 with adjuvant, GEN-004 without adjuvant, or placebo, respectively. Each subject will receive up to 3 doses at 4 week intervals. Subjects will be followed for safety, tolerability, and immunogenicity for 12 months after their last dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
90
normal saline, 0.5 mL per dose
The GEN-004 Low Dose contains 10µg of each of the three antigens.
The GEN-004 Low Dose contains 10µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.
Prism Research
Saint Paul, Minnesota, United States
To evaluate the safety and tolerability of GEN-004 when administered with and without aluminum hydroxide to adult subjects.
Time frame: 12 months after third (last) dose
To evaluate the immunogenicity of GEN-004, as measured by TH17 (IL-17) and IgG responses to the antigens, when administered with and without aluminum hydroxide.
Time frame: 12 months after third (last) dose
To evaluate the durability of immune responses up to 12 months after the last dose.
Time frame: 12 months after third (last) dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The GEN-004 Mid Dose contains 30µg of each of the three antigens.
The GEN-004 Mid Dose contains 30µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.
The GEN-004 High Dose contains 100µg of each of the three antigens.
The GEN-004 High Dose contains 100µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.