Back to resultsExtension Safety and Immunogenicity Study of GPNV-001
Primary Purpose
Pneumococcal Infections
Status
Recruiting
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Gamma-PN3
Pneumovax-23
Prevenar-13
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Pneumococcal Infections
Eligibility Criteria
Inclusion Criteria: Completion of study GPNV-001 as per protocol with no significant deviations. Has provided written informed consent. Exclusion Criteria: Potential participants will be excluded if they have received a pneumococcal vaccine since the end of study visit for study GPNV-001 A potential participant has had an episode of pneumonia since completing Study GPNV-001
Sites / Locations
- University of AdelaideRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Gamma-PN3 50 mcg
Gamma-PN3 250 mcg
Gamma-PN3 1000 mcg
Pneumovax 23
Prevenar-13
Placebo
Arm Description
In GPNV-001 participants will have received 2 doses of 50 mcg Gamma-PN3 at intervals of 4 weeks
In GPNV-001 participants will have received 2 doses of 250 mcg Gamma-PN3 at intervals of 4 weeks
In GPNV-001 participants will have received 2 doses of 1000 mcg Gamma-PN3 at intervals of 4 weeks
In GPNV-001 participants will have received one 0.5ml dose of Pneumovax-23 followed by saline placebo 4 weeks later
In GPNV-001 participants will have received one 0.5ml dose of Prevenar-13 followed by saline placebo 4 weeks later
In GPNV-001 participants will have received two doses of 0.5 ml saline placebo at intervals of 4 weeks.
Outcomes
Primary Outcome Measures
Serum IgG titre to Gamma-PN3
Serum IgG titre to the vaccine
Serious adverse events
Serious adverse events occurring after day 57 of study GPNV-001
Secondary Outcome Measures
Opsonophagocytic antibodies to pneumococcal strains
Serum OPA titres to up to 24 pneumococcal serotypes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05982314
Brief Title
Extension Safety and Immunogenicity Study of GPNV-001
Official Title
A Safety and Immunogenicity Extension Study of GPNV-001
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GPN Vaccines
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A 6 and 12 month safety and immunogenicity study of participants in study GPNV-001, a novel whole-cell pneumococcal vaccine.
Detailed Description
A 6 and 12 month safety and immunogenicity study of participants in study GPNV-001, a novel whole-cell pneumococcal vaccine. Up to 20 participants per cohort will be invited.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gamma-PN3 50 mcg
Arm Type
Experimental
Arm Description
In GPNV-001 participants will have received 2 doses of 50 mcg Gamma-PN3 at intervals of 4 weeks
Arm Title
Gamma-PN3 250 mcg
Arm Type
Experimental
Arm Description
In GPNV-001 participants will have received 2 doses of 250 mcg Gamma-PN3 at intervals of 4 weeks
Arm Title
Gamma-PN3 1000 mcg
Arm Type
Experimental
Arm Description
In GPNV-001 participants will have received 2 doses of 1000 mcg Gamma-PN3 at intervals of 4 weeks
Arm Title
Pneumovax 23
Arm Type
Active Comparator
Arm Description
In GPNV-001 participants will have received one 0.5ml dose of Pneumovax-23 followed by saline placebo 4 weeks later
Arm Title
Prevenar-13
Arm Type
Active Comparator
Arm Description
In GPNV-001 participants will have received one 0.5ml dose of Prevenar-13 followed by saline placebo 4 weeks later
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
In GPNV-001 participants will have received two doses of 0.5 ml saline placebo at intervals of 4 weeks.
Intervention Type
Biological
Intervention Name(s)
Gamma-PN3
Intervention Description
Experimental whole-cell pneumococcal vaccine
Intervention Type
Biological
Intervention Name(s)
Pneumovax-23
Intervention Description
Licensed pneumococcal vaccine
Intervention Type
Biological
Intervention Name(s)
Prevenar-13
Intervention Description
Licensed pneumococcal vaccine
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Saline placebo
Primary Outcome Measure Information:
Title
Serum IgG titre to Gamma-PN3
Description
Serum IgG titre to the vaccine
Time Frame
6 months and 12 months
Title
Serious adverse events
Description
Serious adverse events occurring after day 57 of study GPNV-001
Time Frame
6 months and 12 months
Secondary Outcome Measure Information:
Title
Opsonophagocytic antibodies to pneumococcal strains
Description
Serum OPA titres to up to 24 pneumococcal serotypes
Time Frame
6 months and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Completion of study GPNV-001 as per protocol with no significant deviations.
Has provided written informed consent.
Exclusion Criteria:
Potential participants will be excluded if they have received a pneumococcal vaccine since the end of study visit for study GPNV-001
A potential participant has had an episode of pneumonia since completing Study GPNV-001
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Rolan, MD
Phone
+61 405 670 420
Email
paul@gpnvaccines.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tim Hirst, PhD
Phone
+61 420 942 824
Email
tim@gpnvaccines.com
Facility Information:
Facility Name
University of Adelaide
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5005
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Harris, BSc
Phone
+61-8-7088 7900
Email
kelly.harris@cmax.com.au
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan as yet
Learn more about this trial
Extension Safety and Immunogenicity Study of GPNV-001
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