Serum Collection Study for Assay Development | NCT07205289

Studies
Serum Collection Study for Assay Development

NCT07205289

Sponsor

GPN Vaccines

Status

Recruiting

Last Update Posted

Oct 3, 2025Actual

Enrollment

12Estimated

Phase

Phase 1

Conditions

Pneumococcal Disease, Invasive
Pneumococcal Disease

Interventions

Gamma-PN

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2025Estimated

Primary Completion Date

Jan 2026Estimated

Completion Date

Jun 2026Estimated

First Submitted Date

Sep 25, 2025

First Submission Date that Met QC Criteria

Sep 25, 2025

First Posted Date

Oct 3, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2025

Last Update Posted Date

Oct 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gamma -PN	Experimental	Intramuscular administration 500 mcg	Biological: Gamma-PN

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gamma-PN	Biological	Killed whole-cell pneumococcal vaccine	Gamma -PN

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
OPA	Opsonophagocytic assay	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

good general health

Exclusion Criteria:

no previous pneumococcal vaccine

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nerissa Lakhan, PhD	Contact	+61-432 161 783		nerissa@gpnvaccines.com
Paul E Rolan, MD	Contact	+61-405 670 420		paul@gpnvaccines.com

Overall Officials

Name	Affiliation	Role
Eve Kennedy, PhD	GPN Vaccines Ltd	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Adelaide Clinical Research Facility	Recruiting	Adelaide	South Australia	5000	Australia

Condition Browse Module

MeSH Terms

ID	Term
D011008	Pneumococcal Infections

Ancestor Terms

ID	Term
D013290	Streptococcal Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided