Pneumococcal Disease, InvasivePhase 1NCT07205289
Serum Collection Study for Assay Development
A Phase 1 study testing Gamma-PN in people with Pneumococcal Disease, Invasive and Pneumococcal Disease, run by GPN Vaccines at 1 site in Australia.
Trial summary
The study will collect serum from 12 participants vaccinated with Gamma-PN to assist with assay development and validation Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Disease, Invasive, Pneumococcal Disease
- What is being tested?
- Gamma-PN
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2025to Jun 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- good general health
Who cannot join
- no previous pneumococcal vaccine
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
University of Adelaide Clinical Research Facility
Adelaide, South Australia, 5000
Kirstee Smith, +61-481-589 855, kirstee.smith@adelaide.edu.au
Sepehr Shakib, MD PhD, sepehr.shakib@adelaide.edu.au
About this study
Official 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
The study will collect serum from 12 participants vaccinated with Gamma-PN to assist with assay development and validation
Read the 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
- Being tested
- Gamma-PN
- Keywords
- Vaccination pneumococcal
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma-PNBiological
Killed whole-cell pneumococcal vaccine
| Study group | Role | What they receive |
|---|---|---|
| Gamma -PN | Experimental | Intramuscular administration 500 mcg Receives: Biological: Gamma-PN |
What is being measured
The primary outcome is the main question the study is designed to answer.
OPA
Opsonophagocytic assay
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study startOct 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal Disease, InvasiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GPN Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eve Kennedy, PhD, Study director, GPN Vaccines Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205289
- Sponsor's protocol ID
- GPNV-008
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07205289
- Acronym / sponsor ID
- GPNV-008
- Keywords
- Vaccination pneumococcal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- GPN VaccinesIndustry (pharma, biotech, devices)
- Study start
- Oct 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label
| Arm | Type | Receives |
|---|---|---|
| Gamma -PN | Experimental | Biological: Gamma-PNIntramuscular administration 500 mcg |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- good general health
Key exclusion criteria (1 listed)
- no previous pneumococcal vaccine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamma-PNKilled whole-cell pneumococcal vaccine | Biological | Gamma -PN |
Primary outcome
OPA
Time frame: 6 months
Opsonophagocytic assay
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eve Kennedy, PhD study director
GPN Vaccines Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gamma-PN in people with Pneumococcal Disease, Invasive and Pneumococcal Disease, run by GPN Vaccines at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nerissa Lakhan, PhD (+61-432 161 783, nerissa@gpnvaccines.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OPA (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.