NCT07205289

Brief Summary

The study will collect serum from 12 participants vaccinated with Gamma-PN to assist with assay development and validation

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
1mo left

Started Oct 2025

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Oct 2025Jun 2026

First Submitted

Initial submission to the registry

September 25, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

September 25, 2025

Last Update Submit

September 25, 2025

Conditions

Pneumococcal Disease, InvasivePneumococcal Disease

Keywords

Vaccination pneumococcal

Outcome Measures

Primary Outcomes (1)

  • OPA

    Opsonophagocytic assay

    6 months

Study Arms (1)

Gamma -PN

EXPERIMENTAL

Intramuscular administration 500 mcg

Biological: Gamma-PN

Interventions

Gamma-PNBIOLOGICAL

Killed whole-cell pneumococcal vaccine

Gamma -PN

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • good general health

You may not qualify if:

  • no previous pneumococcal vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Adelaide Clinical Research Facility

Adelaide, South Australia, 5000, Australia

RECRUITING

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Eve Kennedy, PhD

    GPN Vaccines Ltd

    STUDY DIRECTOR

Central Study Contacts

Nerissa Lakhan, PhD

CONTACT

+61-432 161 783nerissa@gpnvaccines.com

Paul E Rolan, MD

CONTACT

+61-405 670 420paul@gpnvaccines.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Open-label
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2025

First Posted

October 3, 2025

Study Start

October 1, 2025

Primary Completion

January 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

October 3, 2025

Record last verified: 2025-09

Locations

AU(1)