Actively Recruiting
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
Led by GPN Vaccines · Updated on 2025-10-03
12
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to collect serum samples from adults vaccinated with Gamma-PN, a killed whole-cell pneumococcal vaccine, to help develop and validate laboratory tests that measure immune response. The study focuses on adults in good general health, aged 18 to 69 years, who have not previously received a pneumococcal vaccine. It is an early phase study designed to gather important data for assay validation. Participants will receive a single intramuscular dose of 500 mcg of Gamma-PN vaccine. Serum samples will be collected before vaccination and again on Day 28 after vaccination. The vaccine administration and sample collection are straightforward, with no placebo or comparison groups involved. During the study, participants will have blood drawn to collect serum at the specified time points. Researchers will monitor immune response by measuring the opsonophagocytic activity (OPA) at six months. The total study duration includes vaccination, follow-up blood draws, and monitoring to support assay development. Participants can expect a limited number of visits focused on vaccination and blood sample collection.
CONDITIONS
Brief Title
Serum Collection Study for Assay Development
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 69 years
- Good general health
You will not qualify if you...
- Previous pneumococcal vaccine received
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants receive a single dose of the Gamma-PN vaccine.
1 visit (in-person)
Duration - 28 days
Serum is collected before vaccination and again on Day 28 to assist with assay development and validation.
2 visits (in-person)
Trial Site Locations
Total: 1 location
1
University of Adelaide Clinical Research Facility
Adelaide, South Australia, Australia, 5000
Actively Recruiting
Research Team
N
Nerissa Lakhan, PhD
P
Paul E Rolan, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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