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Recruiting

NCT Number: NCT07205289

Serum Collection Study for Assay Development

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

Recruiting

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Key information

Conditions

Pneumococcal Disease, Invasive Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Pneumococcal Disease Pneumococcal Infections Streptococcal Infections

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Adelaide Clinical Research Facility

Adelaide, South Australia, 5000, Australia

Location status: Recruiting

Location contact

Kirstee Smith

CONTACT

[email protected]

+61-481-589 855

Sepehr Shakib, MD PhD

CONTACT

[email protected]

Tom Polasek, MD PhD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • good general health

Exclusion criteria

  • no previous pneumococcal vaccine

Treatment and study plan

Gamma-PN

Biological

Killed whole-cell pneumococcal vaccine

Primary outcomes

  1. OPA

    Time frame: 6 months

    Opsonophagocytic assay

Study contacts

Contact information is provided by the study sponsor or research team.

Nerissa Lakhan, PhD

CONTACT

[email protected]

+61-432 161 783

Paul E Rolan, MD

CONTACT

[email protected]

+61-405 670 420

Sponsors and collaborators

Lead sponsor

GPN Vaccines

Industry

Registry information

Official study title

A Phase 1B Open-label Study to Collect Serum Following Vaccination With Killed Whole-cell Pneumococcal Vaccine (Gamma-PN) in Adults for Use in Assay Validation

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 3, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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