Serum Collection Study for Assay Development

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07205289

Enrollment

Registered

2025-10-03

Start date

2025-10-31

Completion date

2026-06-30

Last updated

2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal Disease, Pneumococcal Disease, Invasive

Keywords

Vaccination pneumococcal

Brief summary

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

Detailed description

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

Interventions

BIOLOGICALGamma-PN

Killed whole-cell pneumococcal vaccine

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Open-label

Eligibility

Sex/Gender

ALL

Age

18 Years to 69 Years

Healthy volunteers

Yes

Inclusion criteria

* good general health

Exclusion criteria

* no previous pneumococcal vaccine

Design outcomes

Primary

Measure	Time frame	Description
OPA	6 months	Opsonophagocytic assay

Countries

Australia

Contacts

Primary ContactNerissa Lakhan, PhD

nerissa@gpnvaccines.com+61-432 161 783

Backup ContactPaul E Rolan, MD

paul@gpnvaccines.com+61-405 670 420

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026