Serum Collection Study for Assay Development

NCT ID: NCT07205289

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2026-06-30

Brief Summary

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

Detailed Description

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

Participants will receive a dose of Gamma-PN and serum will be collected pre dose and Day 28

Conditions

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Pneumococcal Disease, Invasive Pneumococcal Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open-label
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Gamma -PN

Intramuscular administration 500 mcg

Group Type EXPERIMENTAL

Gamma-PN

Intervention Type BIOLOGICAL

Killed whole-cell pneumococcal vaccine

Interventions

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Gamma-PN

Killed whole-cell pneumococcal vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* good general health

Exclusion Criteria

* no previous pneumococcal vaccine
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GPN Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eve Kennedy, PhD

Role: STUDY_DIRECTOR

GPN Vaccines Ltd

Locations

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University of Adelaide Clinical Research Facility

Adelaide, South Australia, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Nerissa Lakhan, PhD

Role: CONTACT

+61-432 161 783

Paul E Rolan, MD

Role: CONTACT

+61-405 670 420

Facility Contacts

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Kirstee Smith

Role: primary

+61-481-589 855

Sepehr Shakib, MD PhD

Role: backup

Other Identifiers

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GPNV-008

Identifier Type: -

Identifier Source: org_study_id

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