None listed
Conditions
Brief 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.
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 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
Sponsors
Denteric Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
40 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
- 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 criteria
- 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.
Outcome results
None listed