AV0328 is a novel vaccine candidate intended to raise antibodies to the glucosamine backbone of naturally occurring Poly N-acetyl glucosamine (PNAG), a capsular polysaccharide expressed on the surface of a wide array of microbes.~AV-101-16: A single and repeat dose, dose-escalation phase I/II study to evaluate the safety of intramuscularly administered AV0328. Approximately 16 subjects will be enrolled at a single U.S. center, based on 4 subjects per dose group. The study will consist of 3 parts: Part 1 will be a single dose, dose escalation study; Part 2 will assess the effect of a second dose of AV0328; Part 3 will assess the ability of a booster injection of AV0328 at Month 6 to restore protective titers against N. meningitidis B16B6 bacteria.~Part 1 - Single Administration of AV0328:~Following injection, subjects will be observed for 28 days to determine the safety and tolerability of a single administration of AV0328. Cohort 1 will receive 15 µg to be given as an IM injection on Day 1. Cohorts 2, 3 and 4 will receive 30, 75 and 150 µg, respectively. The first subject of each cohort must be observed for a minimum of 24 hours before the remaining subjects in that group can be treated.~Dosage escalation will occur only after the final subject at each dose level has been observed for a minimum of 2 days and no dose limiting drug-related toxicity has occurred.~Part 2 - Second Administration of AV0328:~Following review of safety and tolerance for a minimum of 22 days of Part 1 by the Safety Review Committee (SRC), subjects from each dose level will return to receive an additional injection at the same dose level of AV0328 on Day 29. Additional safety and pharmacodynamic (PD) data will be collected through Week 52.~Part 3 - Booster Administration of AV0328 Serum drawn at Day 57 revealed that 3 of 4 subjects in Cohort 3 and all 4 subjects in Cohort 4 achieved protective titers against N. meningitidis B16B6 bacteria, defined as >30% killing at a titer of 1:8 or greater by BSA. If those titers fall below protective levels in a subject at 4 or 6 months, that subject will receive a booster injection at the 6-month time point or shortly thereafter. The dose will be 150 µg, IM which will be formulated in the same manner as the 150 µg dose in Parts 1 and 2.
AV0328 is a novel vaccine candidate intended to raise antibodies to the glucosamine backbone of naturally occurring Poly N-acetyl glucosamine (PNAG), a capsular polysaccharide expressed on the surface of a wide array of microbes.~AV-101-16: A single and repeat dose, dose-escalation phase I/II study to evaluate the safety of intramuscularly administered AV0328. Approximately 16 subjects will be enrolled at a single U.S. center, based on 4 subjects per dose group. The study will consist of 3 parts: Part 1 will be a single dose, dose escalation study; Part 2 will assess the effect of a second dose of AV0328; Part 3 will assess the ability of a booster injection of AV0328 at Month 6 to restore protective titers against N. meningitidis B16B6 bacteria.