Pneumococcal InfectionsPhase 1/2NCT05982314
Extension Safety and Immunogenicity Study of GPNV-001
A Phase 1/2 study testing Gamma-PN3, Pneumovax-23 and Prevenar-13 in people with Pneumococcal Infections, run by GPN Vaccines at 1 site in Australia.
Trial summary
A 6 and 12 month safety and immunogenicity study of participants in study GPNV-001, a novel whole-cell pneumococcal vaccine. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections
- What is being tested?
- Gamma-PN3, Pneumovax-23 and Prevenar-13
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteAustralia
- Study dates
- 17 Jul 2023to 30 Aug 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Completion of study GPNV-001 as per protocol with no significant deviations.
- Has provided written informed consent.
Who cannot join
- Potential participants will be excluded if they have received a pneumococcal vaccine since the end of study visit for study GPNV-001
- A potential participant has had an episode of pneumonia since completing Study GPNV-001
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Safety and Immunogenicity Extension Study of GPNV-001
A 6 and 12 month safety and immunogenicity study of participants in study GPNV-001, a novel whole-cell pneumococcal vaccine.
Read the detailed description
A 6 and 12 month safety and immunogenicity study of participants in study GPNV-001, a novel whole-cell pneumococcal vaccine. Up to 20 participants per cohort will be invited.
- Conditions
- Pneumococcal Infections
- Being tested
- Gamma-PN3, Pneumovax-23, Prevenar-13, Placebo
- 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-PN3Biological
Experimental whole-cell pneumococcal vaccine
Pneumovax-23Biological
Licensed pneumococcal vaccine
Prevenar-13Biological
Licensed pneumococcal vaccine
PlaceboBiological
Saline placebo
| Study group | Role | What they receive |
|---|---|---|
| Gamma-PN3 50 mcg | Experimental | In GPNV-001 participants will have received 2 doses of 50 mcg Gamma-PN3 at intervals of 4 weeks Receives: Biological: Gamma-PN3 |
| Gamma-PN3 250 mcg | Experimental | In GPNV-001 participants will have received 2 doses of 250 mcg Gamma-PN3 at intervals of 4 weeks Receives: Biological: Gamma-PN3 |
| Gamma-PN3 1000 mcg | Experimental | In GPNV-001 participants will have received 2 doses of 1000 mcg Gamma-PN3 at intervals of 4 weeks Receives: Biological: Gamma-PN3 |
| Pneumovax 23 | Active comparator | In GPNV-001 participants will have received one 0.5ml dose of Pneumovax-23 followed by saline placebo 4 weeks later Receives: Biological: Pneumovax-23 |
| Prevenar-13 | Active comparator | In GPNV-001 participants will have received one 0.5ml dose of Prevenar-13 followed by saline placebo 4 weeks later Receives: Biological: Prevenar-13 |
| Placebo | Placebo comparator | In GPNV-001 participants will have received two doses of 0.5 ml saline placebo at intervals of 4 weeks. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum IgG titre to Gamma-PN3
Serum IgG titre to the vaccine
Measured: 6 months and 12 months
Serious adverse events
Serious adverse events occurring after day 57 of study GPNV-001
Measured: 6 months and 12 months
Secondary outcomes (1)
Opsonophagocytic antibodies to pneumococcal strains
Serum OPA titres to up to 24 pneumococcal serotypes
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start17 Jul 2023
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal InfectionsStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- GPN Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982314
- Sponsor's protocol ID
- GPNV-002
- Status last verified
- Dec 2024
- First submitted
- 24 Jul 2023
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan as yet
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Immunogenicity Extension Study of GPNV-001
- ClinicalTrials.gov ID
- NCT05982314
- Acronym / sponsor ID
- GPNV-002
- Conditions
- Pneumococcal Infections
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- GPN VaccinesIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 8 Aug 2023 (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.
A 6 and 12 month safety and immunogenicity study of participants in study GPNV-001, a novel whole-cell pneumococcal vaccine.
Detailed description
A 6 and 12 month safety and immunogenicity study of participants in study GPNV-001, a novel whole-cell pneumococcal vaccine. Up to 20 participants per cohort will be invited.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Gamma-PN3 50 mcg | Experimental | Biological: Gamma-PN3In GPNV-001 participants will have received 2 doses of 50 mcg Gamma-PN3 at intervals of 4 weeks |
| Gamma-PN3 250 mcg | Experimental | Biological: Gamma-PN3In GPNV-001 participants will have received 2 doses of 250 mcg Gamma-PN3 at intervals of 4 weeks |
| Gamma-PN3 1000 mcg | Experimental | Biological: Gamma-PN3In GPNV-001 participants will have received 2 doses of 1000 mcg Gamma-PN3 at intervals of 4 weeks |
| Pneumovax 23 | Active comparator | Biological: Pneumovax-23In GPNV-001 participants will have received one 0.5ml dose of Pneumovax-23 followed by saline placebo 4 weeks later |
| Prevenar-13 | Active comparator | Biological: Prevenar-13In GPNV-001 participants will have received one 0.5ml dose of Prevenar-13 followed by saline placebo 4 weeks later |
| Placebo | Placebo comparator | Biological: PlaceboIn GPNV-001 participants will have received two doses of 0.5 ml saline placebo at intervals of 4 weeks. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Completion of study GPNV-001 as per protocol with no significant deviations.
- Has provided written informed consent.
Key exclusion criteria (2 listed)
- Potential participants will be excluded if they have received a pneumococcal vaccine since the end of study visit for study GPNV-001
- A potential participant has had an episode of pneumonia since completing Study GPNV-001
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-PN3Experimental whole-cell pneumococcal vaccine | Biological | Gamma-PN3 1000 mcg, Gamma-PN3 250 mcg, Gamma-PN3 50 mcg |
| Pneumovax-23Licensed pneumococcal vaccine | Biological | Pneumovax 23 |
| Prevenar-13Licensed pneumococcal vaccine | Biological | Prevenar-13 |
| PlaceboSaline placebo | Biological | Placebo |
Primary outcome
Serum IgG titre to Gamma-PN3
Time frame: 6 months and 12 months
Serum IgG titre to the vaccine
Serious adverse events
Time frame: 6 months and 12 months
Serious adverse events occurring after day 57 of study GPNV-001
1 secondary outcome
Opsonophagocytic antibodies to pneumococcal strains
Time frame: 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No. No plan as yet
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gamma-PN3, Pneumovax-23 and Prevenar-13 in people with Pneumococcal Infections, 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 18 Dec 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum IgG titre to Gamma-PN3 (time frame: 6 months and 12 months). The study lists 2 primary outcomes in all. 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 18 Dec 2024.