Extension Safety and Immunogenicity Study of GPNV-001

December 16, 2024 updated by: GPN Vaccines

A Safety and Immunogenicity Extension Study of GPNV-001

A 6 and 12 month safety and immunogenicity study of participants in study GPNV-001, a novel whole-cell pneumococcal vaccine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5005
        • University of Adelaide

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Completion of study GPNV-001 as per protocol with no significant deviations.
  2. Has provided written informed consent.

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gamma-PN3 50 mcg
In GPNV-001 participants will have received 2 doses of 50 mcg Gamma-PN3 at intervals of 4 weeks
Biological: Gamma-PN3
Experimental whole-cell pneumococcal vaccine
Experimental: Gamma-PN3 250 mcg
In GPNV-001 participants will have received 2 doses of 250 mcg Gamma-PN3 at intervals of 4 weeks
Biological: Gamma-PN3
Experimental whole-cell pneumococcal vaccine
Experimental: Gamma-PN3 1000 mcg
In GPNV-001 participants will have received 2 doses of 1000 mcg Gamma-PN3 at intervals of 4 weeks
Biological: Gamma-PN3
Experimental whole-cell pneumococcal vaccine
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
Biological: Pneumovax-23
Licensed pneumococcal vaccine
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
Biological: Prevenar-13
Licensed pneumococcal vaccine
Placebo Comparator: Placebo
In GPNV-001 participants will have received two doses of 0.5 ml saline placebo at intervals of 4 weeks.
Biological: Placebo
Saline placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum IgG titre to Gamma-PN3
Time Frame: 6 months and 12 months
Serum IgG titre to the vaccine
6 months and 12 months
Serious adverse events
Time Frame: 6 months and 12 months
Serious adverse events occurring after day 57 of study GPNV-001
6 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opsonophagocytic antibodies to pneumococcal strains
Time Frame: 6 months and 12 months
Serum OPA titres to up to 24 pneumococcal serotypes
6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GPN Vaccines

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2023

Primary Completion (Actual)

August 30, 2024

Study Completion (Actual)

August 30, 2024

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 8, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 16, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPNV-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan as yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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