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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05982314




Registration number
NCT05982314
Ethics application status
Date submitted
24/07/2023
Date registered
8/08/2023

Titles & IDs
Public title
Extension Safety and Immunogenicity Study of GPNV-001
Scientific title
A Safety and Immunogenicity Extension Study of GPNV-001
Secondary ID [1] 0 0
GPNV-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumococcal Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Gamma-PN3
Treatment: Other - Pneumovax-23
Treatment: Other - Prevenar-13
Treatment: Other - Placebo

Experimental: Gamma-PN3 50 mcg - In GPNV-001 participants will have received 2 doses of 50 mcg Gamma-PN3 at intervals of 4 weeks

Experimental: Gamma-PN3 250 mcg - In GPNV-001 participants will have received 2 doses of 250 mcg Gamma-PN3 at intervals of 4 weeks

Experimental: Gamma-PN3 1000 mcg - In GPNV-001 participants will have received 2 doses of 1000 mcg Gamma-PN3 at intervals of 4 weeks

Active comparator: Pneumovax 23 - In GPNV-001 participants will have received one 0.5ml dose of Pneumovax-23 followed by saline placebo 4 weeks later

Active comparator: Prevenar-13 - In GPNV-001 participants will have received one 0.5ml dose of Prevenar-13 followed by saline placebo 4 weeks later

Placebo comparator: Placebo - In GPNV-001 participants will have received two doses of 0.5 ml saline placebo at intervals of 4 weeks.


Treatment: Other: Gamma-PN3
Experimental whole-cell pneumococcal vaccine

Treatment: Other: Pneumovax-23
Licensed pneumococcal vaccine

Treatment: Other: Prevenar-13
Licensed pneumococcal vaccine

Treatment: Other: Placebo
Saline placebo
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Serum IgG titre to Gamma-PN3
Timepoint [1] 0 0
6 months and 12 months
Primary outcome [2] 0 0
Serious adverse events
Timepoint [2] 0 0
6 months and 12 months
Secondary outcome [1] 0 0
Opsonophagocytic antibodies to pneumococcal strains
Timepoint [1] 0 0
6 months and 12 months

Eligibility
Key inclusion criteria
1. Completion of study GPNV-001 as per protocol with no significant deviations.
2. Has provided written informed consent.
Minimum age
18 Years
Maximum age
69 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Potential participants will be excluded if they have received a pneumococcal vaccine since the end of study visit for study GPNV-001
2. A potential participant has had an episode of pneumonia since completing Study GPNV-001

Study design
Purpose of the study
Prevention
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/08/2024
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
University of Adelaide - Adelaide
Recruitment postcode(s) [1] 0 0
5005 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GPN Vaccines
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Paul Rolan, MD
Address 0 0
Country 0 0
Phone 0 0
+61 405 670 420
Fax 0 0
Email 0 0
paul@gpnvaccines.com
Contact person for scientific queries

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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05982314