Extension Safety and Immunogenicity Study of GPNV-001

Phase 1

Completed

• Conditions: Pneumococcal Infections
• Interventions: Biological: Gamma-PN3; Biological: Prevenar-13; Biological: Pneumovax-23; Biological: Placebo

• Registration Number: NCT05982314
• Lead Sponsor: GPN Vaccines

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.

Study Timeline

• Study Start: 2023-07-17
• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-08-01
• Study First Posted: 2023-08-08
• Primary Completion: 2024-08-30
• Study Completion: 2024-08-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gamma-PN3 50 mcg	Gamma-PN3	In GPNV-001 participants will have received 2 doses of 50 mcg Gamma-PN3 at intervals of 4 weeks
Gamma-PN3 1000 mcg	Gamma-PN3	In GPNV-001 participants will have received 2 doses of 1000 mcg Gamma-PN3 at intervals of 4 weeks
Gamma-PN3 250 mcg	Gamma-PN3	In GPNV-001 participants will have received 2 doses of 250 mcg Gamma-PN3 at intervals of 4 weeks
Prevenar-13	Prevenar-13	In GPNV-001 participants will have received one 0.5ml dose of Prevenar-13 followed by saline placebo 4 weeks later
Pneumovax 23	Pneumovax-23	In GPNV-001 participants will have received one 0.5ml dose of Pneumovax-23 followed by saline placebo 4 weeks later
Placebo	Placebo	In GPNV-001 participants will have received two doses of 0.5 ml saline placebo at intervals of 4 weeks.

Primary Outcome Measures

Name	Time	Method
Serious adverse events	6 months and 12 months	Serious adverse events occurring after day 57 of study GPNV-001
Serum IgG titre to Gamma-PN3	6 months and 12 months	Serum IgG titre to the vaccine

Secondary Outcome Measures

Name	Time	Method
Opsonophagocytic antibodies to pneumococcal strains	6 months and 12 months	Serum OPA titres to up to 24 pneumococcal serotypes

Trial Locations

Locations (1)

University of Adelaide; 🇦🇺 Adelaide, South Australia, Australia