Extension Safety and Immunogenicity Study of GPNV-001

NCT05982314 | Completed Phase 1

• 1 other identifier: GPNV-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pneumococcal Infections

Outcome Measures

Primary Outcomes (2)

• Serum IgG titre to Gamma-PN3

  Serum IgG titre to the vaccine

  6 months and 12 months

• Serious adverse events

  Serious adverse events occurring after day 57 of study GPNV-001

  6 months and 12 months

Secondary Outcomes (1)

• Opsonophagocytic antibodies to pneumococcal strains

  6 months and 12 months

Study Arms (6)

Gamma-PN3 50 mcg

EXPERIMENTAL

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

Biological: Gamma-PN3

Gamma-PN3 250 mcg

EXPERIMENTAL

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

Biological: Gamma-PN3

Gamma-PN3 1000 mcg

EXPERIMENTAL

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

Biological: Gamma-PN3

Pneumovax 23

ACTIVE COMPARATOR

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

Biological: Pneumovax-23

Prevenar-13

ACTIVE COMPARATOR

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

Biological: Prevenar-13

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

Gamma-PN3 BIOLOGICAL

Experimental whole-cell pneumococcal vaccine

Gamma-PN3 1000 mcg; Gamma-PN3 250 mcg; Gamma-PN3 50 mcg

Pneumovax-23 BIOLOGICAL

Licensed pneumococcal vaccine

Pneumovax 23

Prevenar-13 BIOLOGICAL

Licensed pneumococcal vaccine

Prevenar-13

Placebo BIOLOGICAL

Saline placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• GPN Vaccines: lead

Study Sites (1)

University of Adelaide

Adelaide, South Australia, 5005, Australia

Location

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 8, 2023
• Study Start: July 17, 2023
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)