This is a randomized, observer-blind, placebo-controlled trial in male and female subjects ≥18 to \<50 years of age. Subjects will be healthy adults based on history, physical examination, and baseline clinical laboratory testing. Approximately 230 eligible subjects will be enrolled into 1 of 13 treatment groups. Treatments will comprise two IM doses at a 21-day interval (Day 0 and Day 21), in alternate deltoids with the test article assigned (i.e., saline placebo, dose of EBOV GP vaccine with or without Matrix-M adjuvant), in a 0.5mL injection volume.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
230
Q-Pharm Pty Ltd.
Brisbane, Queensland, Australia
Nucleus Network
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Assessment of Adverse Events, SAEs, Medically Attended Events and Significant New Medical Conditions.
Numbers and percentages (with 95% confidence intervals \[CIs\]) of subjects with solicited local and systemic AEs over the 7 days post-injection; and all AEs, solicited and unsolicited, including adverse changes in clinical laboratory parameters, over 84 days post-first injection. In addition, MAEs, SAEs, and SNMCs will be collected for one year after the second dose.
Time frame: Day 0 to Day 385
Immunogenicity as assessed by serum IgG antibody levels specific for EBOV Gp antigen as detected by ELISA.
* Geometric mean titer (GMT) * Geometric mean ratio (GMR) * Seroconversion rate (SCR) * Seroresponse rate (SRR)
Time frame: Day 0 to Day 385
Immunogenicity as assessed by epitope-specific immune responses to the EBOV GP antigen measured by serum titers in a competition ELISA assay using known-neutralizing monoclonal antibodies.
* Geometric mean titer (GMT) * Geometric mean ratio (GMR) * Seroconversion rate (SCR) * Seroresponse rate (SRR)
Time frame: Day 0 to Day 385
Immunogenicity as assessed by serum EBOV neutralizing antibody reciprocal titers as detected by a VSV pseudotype-based method.
* Geometric mean titer (GMT) * Geometric mean ratio (GMR) * Seroconversion rate (SCR) * Seroresponse rate (SRR)
Time frame: Day 0 to Day 385
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