PNAG-expressing Pathogenic Microbes VaccinePhase 1/2NCT02853617
A Study of AV0328 Administered to Healthy Adult Volunteers
A Phase 1/2 study testing AV0328 - Cohort 1, AV0328 - Cohort 2 and AV0328 - Cohort 3 in people with PNAG-expressing Pathogenic Microbes Vaccine, run by Alopexx Vaccine, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PNAG-expressing Pathogenic Microbes Vaccine
- What is being tested?
- AV0328 - Cohort 1, AV0328 - Cohort 2 and AV0328 - Cohort 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2017to 23 Apr 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Inflamax Research, Inc.
Neptune City, New Jersey, 07753
About this study
Official title: A Phase I/II, Single and Repeat Dose, Dose Escalation Study of AV0328 Administered to Healthy Adult Volunteers
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.
Read the detailed 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.
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.
- Being tested
- AV0328 - Cohort 1, AV0328 - Cohort 2, AV0328 - Cohort 3, AV0328 - Cohort 4
- Keywords
- S. pneumoniae, N. meningitidis, H. influenza, B. pertussis, C. tetani, MRSA
- Medical subject headings
- Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV0328 - Cohort 1Biological
Also called study drug
Cohort 1 will receive 15 µg to be given as an IM injection
AV0328 - Cohort 2Biological
Also called study drug
Cohort 2 will receive 30 µg to be given as an IM injection
AV0328 - Cohort 3Biological
Also called study drug
Cohort 3 will receive 75 µg to be given as an IM injection
AV0328 - Cohort 4Biological
Also called study drug
Cohort 4 will receive 150 µg to be given as an IM injection
| Study group | Role | What they receive |
|---|---|---|
| AV0328 - Cohort 1 | Experimental | Cohort 1 will receive 15 µg to be given as an IM injection Receives: Biological: AV0328 - Cohort 1 |
| AV0328 - Cohort 2 | Experimental | Cohorts 2 will receive 30 µg to be given as an IM injection Receives: Biological: AV0328 - Cohort 2 |
| AV0328 - Cohort 3 | Experimental | Cohorts 3 will receive 75 µg to be given as an IM injection Receives: Biological: AV0328 - Cohort 3 |
| AV0328 - Cohort 4 | Experimental | Cohorts 4 will receive 150 µg to be given as an IM injection Receives: Biological: AV0328 - Cohort 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with treatment-related adverse events (AEs) at Day 57 following AV0328 vaccination
Continuous safety and tolerability monitoring of escalating doses of AV0328 in healthy adult volunteers at Day 57 with special attention to changes in bowel habits
Measured: Day 1 through Day 57
Secondary outcomes (1)
Serologic evidence of efficacy of AV0328 against S. pneumoniae, N. meningitidis, and methicillin-resistant S. aureus at Day 57
Serologic evidence of efficacy measured by pharmacodynamic blood biomarkers
Measured: Pre-dose, Days 29 and 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study start22 Mar 2017
- Primary completion23 Apr 2018
- Study completion23 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PNAG-expressing Pathogenic Microbes VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alopexx Vaccine, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hal Landy, MD, Study director, Alopexx Vaccine, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853617
- Sponsor's protocol ID
- AV-101-16
- Status last verified
- Mar 2019
- First submitted
- 21 Jul 2016
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Single and Repeat Dose, Dose Escalation Study of AV0328 Administered to Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02853617
- Acronym / sponsor ID
- AV-101-16
- Keywords
- S. pneumoniae, N. meningitidis, H. influenza, B. pertussis, C. tetani, MRSA
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Alopexx Vaccine, LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 23 Apr 2018 (actual)
- Study completion
- 23 Apr 2018 (actual)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AV0328 - Cohort 1 | Experimental | Biological: AV0328 - Cohort 1Cohort 1 will receive 15 µg to be given as an IM injection |
| AV0328 - Cohort 2 | Experimental | Biological: AV0328 - Cohort 2Cohorts 2 will receive 30 µg to be given as an IM injection |
| AV0328 - Cohort 3 | Experimental | Biological: AV0328 - Cohort 3Cohorts 3 will receive 75 µg to be given as an IM injection |
| AV0328 - Cohort 4 | Experimental | Biological: AV0328 - Cohort 4Cohorts 4 will receive 150 µg to be given as an IM injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AV0328 - Cohort 1Also: study drugCohort 1 will receive 15 µg to be given as an IM injection | Biological | AV0328 - Cohort 1 |
| AV0328 - Cohort 2Also: study drugCohort 2 will receive 30 µg to be given as an IM injection | Biological | AV0328 - Cohort 2 |
| AV0328 - Cohort 3Also: study drugCohort 3 will receive 75 µg to be given as an IM injection | Biological | AV0328 - Cohort 3 |
| AV0328 - Cohort 4Also: study drugCohort 4 will receive 150 µg to be given as an IM injection | Biological | AV0328 - Cohort 4 |
Primary outcome
Number of patients with treatment-related adverse events (AEs) at Day 57 following AV0328 vaccination
Time frame: Day 1 through Day 57
Continuous safety and tolerability monitoring of escalating doses of AV0328 in healthy adult volunteers at Day 57 with special attention to changes in bowel habits
1 secondary outcome
Serologic evidence of efficacy of AV0328 against S. pneumoniae, N. meningitidis, and methicillin-resistant S. aureus at Day 57
Time frame: Pre-dose, Days 29 and 57
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hal Landy, MD study director
Alopexx Vaccine, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AV0328 - Cohort 1, AV0328 - Cohort 2 and AV0328 - Cohort 3 in people with PNAG-expressing Pathogenic Microbes Vaccine, run by Alopexx Vaccine, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with treatment-related adverse events (AEs) at Day 57 following AV0328 vaccination (time frame: Day 1 through Day 57). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.