NCT02853617

A Study of AV0328 Administered to Healthy Adult Volunteers

Completed Phase 1, PHASE2 Last updated 19 March 2019

What this trial tests

Phase 1, PHASE2 trial testing AV0328 - Cohort 1 in PNAG-expressing Pathogenic Microbes Vaccine in 16 participants. Completed in 23 April 2018.

Timeline

22 March 2017

Primary endpoint
23 April 2018

23 April 2018

Quick facts

Lead sponsor	Alopexx Vaccine, LLC
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	none
Primary purpose	prevention
Enrollment	16
Start date	22 March 2017
Primary completion	23 April 2018
Estimated completion	23 April 2018
Sites	1 location across United States

Drugs / interventions tested

• AV0328 - Cohort 1 — full drug profile →
• AV0328 - Cohort 2
• AV0328 - Cohort 3
• AV0328 - Cohort 4

Conditions studied

• PNAG-expressing Pathogenic Microbes Vaccine — all drugs for PNAG-expressing Pathogenic Microbes Vaccine →

Sponsor

Alopexx Vaccine, LLC — full company profile →

Who can join

18 and older, any sex, with PNAG-expressing Pathogenic Microbes Vaccine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antibody to Poly-N-acetyl glucosamine provides protection against intracellular pathogens: Mechanism of action and validation in horse foals challenged with Rhodococcus equi.
   Cywes-Bentley C, Rocha JN, Bordin AI, Vinacur M, et al · · 2018 · cited 39× · PMID 30024986 · DOI 10.1371/journal.ppat.1007160
2. Immunization against poly-<i>N</i>-acetylglucosamine reduces neutrophil activation and GVHD while sparing microbial diversity.
   Hülsdünker J, Thomas OS, Haring E, Unger S, et al · · 2019 · cited 28× · PMID 31527267 · DOI 10.1073/pnas.1908549116
3. Strategies to Tackle Antimicrobial Resistance: The Example of <i>Escherichia coli</i> and <i>Pseudomonas aeruginosa</i>.
   Antonelli G, Cappelli L, Cinelli P, Cuffaro R, et al · · 2021 · cited 25× · PMID 34066555 · DOI 10.3390/ijms22094943
4. A comprehensive synthetic library of poly-N-acetyl glucosamines enabled vaccine against lethal challenges of Staphylococcus aureus.
   Tan Z, Yang W, O'Brien NA, Pan X, et al · · 2024 · cited 11× · PMID 38658531 · DOI 10.1038/s41467-024-47457-4
5. Antibodies to Conserved Surface Polysaccharides Protect Mice Against Bacterial Conjunctivitis.
   Zaidi TS, Zaidi T, Pier GB. · · 2018 · cited 8× · PMID 29847658 · DOI 10.1167/iovs.18-23795