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A Study of AV0328 Administered to Healthy Adult Volunteers

NCT02853617 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-03-19

No results posted yet for this study

Summary

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.

Conditions

  • PNAG-expressing Pathogenic Microbes Vaccine

Interventions

BIOLOGICAL

AV0328 - Cohort 1

Cohort 1 will receive 15 µg to be given as an IM injection

BIOLOGICAL

AV0328 - Cohort 2

Cohort 2 will receive 30 µg to be given as an IM injection

BIOLOGICAL

AV0328 - Cohort 3

Cohort 3 will receive 75 µg to be given as an IM injection

BIOLOGICAL

AV0328 - Cohort 4

Cohort 4 will receive 150 µg to be given as an IM injection

Sponsors & Collaborators

  • Alopexx Vaccine, LLC

    lead INDUSTRY

Principal Investigators

  • Hal Landy, MD · Alopexx Vaccine, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-22
Primary Completion
2018-04-23
Completion
2018-04-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02853617 on ClinicalTrials.gov