A Study of AV0328 Administered to Healthy Adult Volunteers

Completed · Phase 1/Phase 2

Conditions studied: PNAG-expressing Pathogenic Microbes Vaccine

In brief

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.

Key facts

Study ID

NCT02853617

Run by

Alopexx Vaccine, LLC

People needed

16

Starts

2017-03-22

Expected to finish

2018-04-23

Last updated by the study team

2019-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy adult volunteer.
• Age 18-55 years, inclusive.
• Normal hematological, hepatic, and renal function.
• Subjects participating in the study are to use adequate birth control measures (abstinence, oral contraceptives, barrier method with spermicide or surgical sterilization) during study participation. Females of childbearing potential must have a negative pregnancy test on the days of dosing. A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months.
• If subject is female and of childbearing potential, she has a negative serum pregnancy test during screening and baseline and must be willing to undergo urine pregnancy testing during the study.
• Subject must sign written informed consent and be willing and able to comply with protocol requirements.
• Subject must be accessible for repeat dosing and follow-up.

You may not qualify if…

• Major organ dysfunction.
• Any significant pre-existing condition preventing full compliance with the study.
• Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 3 months before receipt of study vaccine.
• Allergic to vaccine components of AV0328, including poly N-acetyl glucosamine (PNAG), tetanus toxoid (TT) or alum; any previous severe reaction to any TT vaccine including arthus-type hypersensitivity reaction.
• Vaccinations within one month prior to participation or 2 months after enrollment.
• Women who are pregnant or lactating.
• Abnormal skin or tattoo overlying the deltoid muscle in the immediate vicinity of the anticipated injection sites.
• Donation of blood volume of 250 mL or greater or donation of plasma within 3 months prior to enrollment through conclusion of the study.
• Bleeding condition associated with prolonged bleeding time that may contraindicate intramuscular (IM) injection or blood draw including subjects taking anticoagulant, antiplatelet and/or antithrombotic agents except for low-dose daily aspirin within 30 days before enrollment through completion Day 57.
• Subjects currently on immunosuppressive or immunomodifying therapy or with a history of immunosuppressive or immunomodifying therapy (including systemic glucocorticoid therapy within 30 days of .AV0328 administration) .
• Participation in other investigational or interventional studies within 30 days before the current study begins and/or during study participation. Participation in purely observational studies is acceptable.
• Known active disease with human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV), or positive screening test for HIV, HBV and/or HCV.
• A prior history of brachial neuritis, Guillan-Barre syndrome or other serious neurologic illness.
• Prior severe staphylococcal infection or bacteremia.
• Any clinically significant abnormality in any screening or Baseline laboratory test or electrocardiogram (ECG).
• Medical condition or circumstance that, in the opinion of the investigator, might compromise the subject's ability to comply with the protocol or the subject's well-being or safety.
• In addition, any patient who has met all of the eligibility criteria and has been enrolled in the study who subsequently experiences an acute febrile illness, must be afebrile for at least two days before administration of the study drug.

Where it is running

• Inflamax Research, Inc. — Neptune City, New Jersey, United States

Full record on ClinicalTrials.gov

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