First time in human study of GPV381 in healthy volunteers with Porphyromonas gingivalis bacteria
- Conditions
- PeriodontitisOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12623001260617
- Lead Sponsor
- Denteric Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 24
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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety of GPV381 as assessed by occurrence and incidence of treatment emergent adverse events (TEAEs) [There are no expected TEAEs at this stage of development.<br><br>TEAEs will be recorded and assessed by asking participants if they have experienced any and by direct observation during study visits.<br><br>Participants will also complete a diary card to record any specific injection site reactions in the 1 week following each dose. From first dose of study product on Day 1 to End of Study (EoS) on Day 120 post baseline];Safety of GPV381[Assessed by physical examination including vital signs (blood pressure measured by machine or manual sphygmomanometer, heart rate and respiratory rate by manual count, and temperature by thermometer) Days 8, 28, 35, 56, 63, 90, and 120 post baseline compared to Day 1<br>];Safety of GPV381[Changes in blood tests including haematology, biochemistry, and coagulation Days 8, 35, 63, 90, and 120 post baseline compared to Day 1]
- Secondary Outcome Measures
Name Time Method To assess the immune response to DNT038[Laboratory measurement of specific antibody responses in blood.<br> Days 8, 28, 35, 56, 63, 90 and 120 post baseline compared to Day 1];Primary - Safety of GPV381[Primary - Changes in cytokine levels (proteins in the immune system) in blood and saliva Days 8, 28, 35, 56, 63, 90, and 120 post baseline compared to Day 1];To assess the immune response to DNT038[Laboratory measurement of specific cytokines in blood and saliva Days 8, 28, 35, 56, 63, 90 and 120 post baseline compared to Day 1]