Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12623001260617
Ethics application status
Approved
Date submitted
4/10/2023
Date registered
5/12/2023
Date last updated
14/01/2024
Date data sharing statement initially provided
5/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
First time in human study of GPV381 in healthy volunteers with Porphyromonas gingivalis bacteria
Scientific title
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
Secondary ID [1] 310729 0
DEN-GPV381-HV01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Periodontitis 331670 0
Condition category
Condition code
Oral and Gastrointestinal 328398 328398 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 327133 0
Treatment: Drugs
Comparator / control treatment
Within each cohort 2 participants will receive a placebo (dilution buffer) dose as a 0.5mL intramuscular injection to the upper arm, on Day 1, Day 28, and Day 56 (3 doses).

Follow up visits 1 week post each dose and at 3 and 4 months post dose 1
Control group
Placebo

Outcomes
Primary outcome [1] 336232 0
Safety of GPV381 as assessed by occurrence and incidence of treatment emergent adverse events (TEAEs)
Timepoint [1] 336232 0
From first dose of study product on Day 1 to End of Study (EoS) on Day 120 post baseline
Primary outcome [2] 336233 0
Safety of GPV381
Timepoint [2] 336233 0
Days 8, 28, 35, 56, 63, 90, and 120 post baseline compared to Day 1
Primary outcome [3] 336649 0
Safety of GPV381
Timepoint [3] 336649 0
Days 8, 35, 63, 90, and 120 post baseline compared to Day 1
Secondary outcome [1] 427467 0
To assess the immune response to DNT038
Timepoint [1] 427467 0
Days 8, 28, 35, 56, 63, 90 and 120 post baseline compared to Day 1
Secondary outcome [2] 429166 0
Primary - Safety of GPV381
Timepoint [2] 429166 0
Days 8, 28, 35, 56, 63, 90, and 120 post baseline compared to Day 1
Secondary outcome [3] 429168 0
To assess the immune response to DNT038
Timepoint [3] 429168 0
Days 8, 28, 35, 56, 63, 90 and 120 post baseline compared to Day 1

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314952 0
Commercial sector/Industry
Name [1] 314952 0
Denteric Pty Ltd
Country [1] 314952 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Denteric Pty Ltd
Address
Level 9, 31 Queen St, Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 316954 0
None
Name [1] 316954 0
Address [1] 316954 0
Country [1] 316954 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313932 0
The Alfred HREC
Ethics committee address [1] 313932 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 313932 0
Australia
Date submitted for ethics approval [1] 313932 0
22/11/2023
Approval date [1] 313932 0
20/12/2023
Ethics approval number [1] 313932 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129838 0
Dr Philip Ryan
Address 129838 0
Nucleus Network, 89 Commercial Road, Melbourne, VIC 3004
Country 129838 0
Australia
Phone 129838 0
+61 3 8593 9800
Fax 129838 0
Email 129838 0
[email protected]
Contact person for public queries
Name 129839 0
Ms Nicole Kruger
Address 129839 0
Denteric Pty Ltd, Level 9, 31 Queen St, Melbourne VIC 3000
Country 129839 0
Australia
Phone 129839 0
+61 425 846 036
Fax 129839 0
Email 129839 0
[email protected]
Contact person for scientific queries
Name 129840 0
Ms Larisa Chisholm
Address 129840 0
Denteric Pty Ltd, Level 9, 31 Queen St, Melbourne VIC 3000
Country 129840 0
Australia
Phone 129840 0
+61 3 9657 0700
Fax 129840 0
Email 129840 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.