ActivePhase 1ACTRN12623001260617

First time in human study of GPV381 in healthy volunteers with Porphyromonas gingivalis bacteria

A Phase 1 randomised, double blind, placebo-controlled study of the safety and immune response to GPV381 in otherwise healthy adults with detectable Porphyromonas gingivalis

Sponsor

Denteric Pty Ltd

Enrollment

24 participants

Start Date

Feb 27, 2024

Study Type

Interventional

Conditions

Periodontitis

Summary

This study will assess the safety and immune response to GPV381. Participants will be admitted as day patients to the unit and receive a dose of IP on Day 1 and remain in the unit for 4 hours post dose for tests and observations. They will be discharged following assessments and return for an outpatient visit on Day 8. They will be readmitted as a day patient for a second and third dose on Day 28 and Day 56, respectively, and return for outpatient safety assessments on Days 35 and 63, and for longer-term safety and immunogenicity follow up visits on Day 90 and Day 120.

Eligibility

Sex: Both males and femalesMin Age: 40 YearssMax Age: 60 Yearss

Inclusion Criteria5

Provide written informed consent prior to any study procedures and agree to adhere to all protocol requirements.
Are male or female 40-60 years of age.
Have detectable P. gingivalis in saliva at Screening
Have an area on the upper arm that will allow adequate observation of any injection site reactions.
Agree to practice effective contraception during the study period.

Exclusion Criteria10

Are pregnant, breast feeding, or plan to become pregnant during the study period.
Have had treatment with any other investigational therapy within 30 days or within 5 half-lives of that investigational therapy, whichever is longer, prior to Day 1.
Have had treatment with antibiotics within one month of commencement on trial or expect to require antibiotic treatment during the trial.
Have a known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as congenital or acquired immunodeficiency, including infection with human immunodeficiency virus (HIV).
Have clinically significant gingivitis or periodontal disease or are undergoing a current treatment plan for these.
Full or partial dentures, or dental implants.
Chronic use (more than 14 continuous days) of any medication that may be associated with changes in immune function
Have clinically significant laboratory values at Screening, as assessed by an investigator.
Have donated blood or blood-derived products (plasma) within 30 days or received blood or blood-derived products (plasma) within 90 days prior to Day 1 or plans to donate or use blood or blood products during the course of the study.
Have any other medical condition or significant co-morbidities, clinically relevant social or psychiatric conditions, or any finding during Screening or on Day 1, which in the investigator’s opinion may increase the risk associated with study participation or interfere with the participant’s ability to comply with study procedures.

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Interventions

Three sequential cohorts will receive a dose of GPV381 as a 0.5mL intramuscular injection to the upper arm, on Day 1, Day 28, and Day 56 (3 doses). There will be 8 participants per cohort, 6 of whom

Three sequential cohorts will receive a dose of GPV381 as a 0.5mL intramuscular injection to the upper arm, on Day 1, Day 28, and Day 56 (3 doses). There will be 8 participants per cohort, 6 of whom will receive GPV381 Cohort 1: 110 micrograms Cohort 2: 220 micrograms Cohort 3: 440 micrograms Follow up visits 1 week post each dose and at 3 and 4 months post dose 1