Serum collection after Gamma-PN vaccination to support 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
PHASE1 · GPN Vaccines · NCT07205289
This project will collect blood samples from people who receive the Gamma-PN vaccine to help develop lab tests for pneumococcal disease.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 69 Years |
| Sex | All |
| Sponsor | GPN Vaccines (industry) |
| Locations | 1 site (Adelaide, South Australia) |
| Trial ID | NCT07205289 on ClinicalTrials.gov |
What this trial studies
Twelve participants will receive a single dose of Gamma-PN and have serum collected before dosing and again on Day 28 to provide samples for assay development and validation. The open-label, Phase 1 interventional protocol is limited to one site at the University of Adelaide Clinical Research Facility. Eligible volunteers must be in good general health and not have previously received a pneumococcal vaccine. Samples will be used to optimize and validate laboratory methods rather than to measure therapeutic outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults in good general health who have not previously received a pneumococcal vaccine and can attend the University of Adelaide site for dosing and a Day 28 follow-up visit.
Not a fit: People who have already received a pneumococcal vaccine or who are seeking direct treatment benefit from vaccination are unlikely to gain personal clinical benefit from participation.
Why it matters
Potential benefit: If successful, this work could produce more reliable lab tests to measure immune responses to pneumococcal vaccination and support future vaccine development.
How similar studies have performed: Collecting serum after vaccination is a common and generally successful method for developing and validating assays, although data specific to Gamma-PN are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * good general health Exclusion Criteria: * no previous pneumococcal vaccine
Where this trial is running
Adelaide, South Australia
- University of Adelaide Clinical Research Facility — Adelaide, South Australia, Australia (RECRUITING)
Study contacts
- Study coordinator: Nerissa Lakhan, PhD
- Email: nerissa@gpnvaccines.com
- Phone: +61-432 161 783
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pneumococcal Disease, Invasive, Pneumococcal Disease, Vaccination pneumococcal