A Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-A1 in Healthy Young Adults
This is a phase 1, first-in-human, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, and immunogenicity of VAX-A1 in healthy adults 18-40 years of age.
• Individuals 18-40 years of age (inclusive) at the time of randomization into the study
• Able and willing to complete the informed consent process
• Available for clinical follow-up through the last study visit at 6 months post-Dose 2
• Willing to have blood samples collected, stored indefinitely, and be used for research purposes
• Able to provide proof of identity to the satisfaction of the study staff completing the enrollment process
• Healthy, as defined by absence of clinically significant medical condition, either acute or chronic, as determined by medical history, vital signs, physical examination, screening laboratory test results, TTE and ECG results, and clinical assessment by the Investigator
• For applicable individuals, postmenopausal (as confirmed by follicle-stimulating hormone \[FSH\] level at Screening) for at least 1 year, or surgically sterile for at least 6 months prior to dosing
• Individuals of childbearing potential must be not pregnant and not lactating, must have negative urine and serum pregnancy tests at Screening and a negative urine pregnancy test immediately prior to randomization, and agree to use acceptable contraception if heterosexually active. Participants must agree to consistently practice contraception if sexually active at least 7 days prior to enrollment and throughout the duration of the study
• Able to access and use a smartphone, tablet, computer, or other device connected to Wi-Fi or cellular network for completion of an eDiary