Pneumonia, PneumococcalPhase 1NCT06562790
Study of Gamma PN3 in the Elderly
A Phase 1 study testing Gamma PN3 and Prevnar in people with Pneumonia, Pneumococcal, run by GPN Vaccines at 1 site in Australia.
Trial summary
Phase 1 double- blind randomised active comparator dose escalating study of Gamma PN3 in the elderly Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Pneumococcal
- What is being tested?
- Gamma PN3 and Prevnar
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteAustralia
- Study dates
- 26 Aug 2024to 31 Mar 2025
- Phase
- Phase 1
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Male or female volunteers aged 70 years and over at Screening.
- In stable good general health as determined by the outcome of medical history, physical examination, and clinical judgement by the Investigator. Chronic stable non-inflammatory conditions such as hypertension, hyperlipidemia, well-controlled type 2 diabetes, stable asthma, controlled psychiatric conditions such as anxiety or depression, stable ischemic heart disease with heart failure not greater than NYHA Grade 1 and 2 are permitted, as determined by the Investigator.
- Willing and able to give voluntary written informed consent before screening assessments commence.
- Vital signs within the following ranges (inclusive):
- Body temperature 35.5 to 37.7°C
- Heart rate 50 to 100 beats per minute although atrial fibrillation is allowed.
Show all 16Show fewer
- Respiratory rate 12 to 22 breaths per minute
- Systolic blood pressure 90 to 160 mmHg
- Diastolic blood pressure 50 to 95 mmHg
- 12-lead ECG parameters within the following ranges:
- QTcB \& QTcF - males ≤450 msec. females ≤470 msec
- PR 100 to 240 msec inclusive
- Heart rate (HR) 50 to 100 beats per minute (bpm) inclusive; atrial fibrillation is allowed.
- Willing and able to communicate with the Investigator and study team and understands the requirements of the study.
- Willing and able to undertake the study visits and all assessments, including possessing a suitable device and access to the internet for using the web-based electronic diary (e.g., smartphone, tablet, or computer) and able to use the device for this purpose.
- Vaccinated against severe acute respiratory syndrome corona virus 2 (SARS-CoV-2; COVID-19) with a minimum of a prime and boost vaccinations.
Who cannot join
- 1. History of a previous Pneumovax 23® vaccination in last 12 months. 2. History of a previous Prevenar 13® or Prevenar 20® vaccination in last 12 months.
- 3. Positive serology blood test for human immunodeficiency virus (HIV) antibodies, hepatitis B virus (HBV) surface antigen or Hepatitis C virus (HCV) antibodies. Positive serology to Hepatitis C due to previous successfully treated infection with negative polymerase chain reaction (PCR) is not exclusionary.
- 4. Infectious disease including but not limited to COVID-19 and influenza within 30 days before Screening and any time between Screening and Day 1 first dose, as this may confound immune response to study vaccine.
- 5. Liver function tests (including aspartate aminotransferase [AST], alanine aminotransferase [ALT], bilirubin) >1.5 upper limit of normal (ULN).
- 6. Clinically significant abnormalities in laboratory tests (biochemistry, haematology), physical examination, or 12-lead ECG during the Screening period that, in the opinion of the Investigator, would affect immune response to vaccination and/or ability to fully participate in the study and/or not be in the individual's best interest to participate in the study. One re-test per abnormality is permitted.
- 7. Participation in another clinical study of any investigational or licensed product (including investigational COVID-19 vaccines, drugs, medical devices) or medical procedure within 4 weeks from last study visit before screening.
Show all 16Show fewer
- 8. Plan to have a vaccine during the study period including COVID-19 booster. 9. Have had a live vaccine within three months of the first dose of study product or any other vaccine (including any COVID-19 vaccine) within 28 days of the first dose of study product.
- Examples of live vaccines include, but are not limited to the following: measles, mumps, rubella, chicken pox/zoster (Zostavax; Shingrix is allowed), monkeypox, yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid (oral) vaccines. Seasonal influenza vaccines for injection are generally killed virus vaccines and are permitted if administered at least 28 days before the first dose of study treatment and not during the enrollment or the study period. However, intranasal influenza vaccines are live attenuated vaccines and are not permitted within three months of first dose.
- 10. Have received blood or blood-derived products in the last three months before screening, which might interfere with assessment of the immune response.
- 11. Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the last six months before screening; or long-term systemic corticosteroid therapy (prednisone at a dose of 5mg daily or equivalent for more than two consecutive weeks within the last month before screening, depot or intraarticular steroids within 3 months before screening).
- 12. A systemic inflammatory condition such as rheumatoid arthritis or inflammatory bowel disease.
- 13. Any medical condition requiring immunosuppressive therapy. 14. History of severe allergic reaction e.g., severe cutaneous adverse reaction or anaphylaxis to any medicinal product or to any of the study treatments, including excipients.
- 15. Current alcohol abuse (> 21 U/week for men and 14 U/week for women), substance dependence including nicotine/tobacco smoking (defined as more than 5 cigarettes or tobacco/nicotine equivalent per day; smoking or vaping will not be permitted while at the study unit), any use of illicit drugs or other addiction which might interfere with the ability to comply with study procedures in the opinion of the Investigator; positive drugs of abuse screen (tricyclic antidepressants, opioids, and benzodiazepines are not exclusionary if prescribed by a physician and consistent with medical history) or positive alcohol breath test at Screening or pre-dose. One re-test permitted for drugs of abuse screen where justified (e.g., false positive suspected).
- 16. Clinically significant chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion. Examples include congestive heart failure NHYA Grade 3 or 4, COAD with breathlessness interfering with daily activities; severe psychiatric conditions, poorly controlled asthma or diabetes 17. Any chronic medical condition e.g., asthma, gout, which is likely to need systemic corticosteroid therapy during the study.
- 18. Renal impairment requiring dialysis 19. Identified as a site employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife or de facto and their children, adopted or natural) of the site employees or the Investigator.
- 20. Poor venous access making scheduled blood sampling likely to be unsuccessful
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomised, Active-controlled, Blinded, Dose-ranging Study of the Safety, Tolerability, and Immunogenicity of an Inactivated Whole-cell Pneumococcal Vaccine (Gamma-PN3) in Elderly Participants
Phase 1 double- blind randomised active comparator dose escalating study of Gamma PN3 in the elderly
Read the detailed description
The study is a phase 1, randomised, active-controlled, double-blind sequential ascending-dose study to evaluate the safety, tolerability, and immunogenicity of Gamma-PN3 in elderly adults. Three sequential, ascending dose cohorts are planned, with 35 participants per cohort randomised to one of two treatment arms. Administration of allocated study treatments will be on Days 1 and 29, with one treatment arm consisting of two doses of Gamma-PN3, and the treatment arm consisting of the comparator vaccine Prevenar 13® (one dose only, with second dose of Placebo).
Immunogenicity will be assessed at Day 29 and Day 57
- Conditions
- Pneumonia, Pneumococcal
- Being tested
- Gamma PN3, Prevnar
- Medical subject headings
- Pneumonia, Pneumococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma PN3Biological
500, 1000 or 1500 µg by IM injection on Days 1 and 29
PrevnarBiological
1 dose on Day 1 and saline placebo on Day 29
| Study group | Role | What they receive |
|---|---|---|
| Gamma-PN3 | Experimental | 2 doses on Days 1 and 29 Receives: Biological: Gamma PN3 |
| Prevnar | Active comparator | 1 dose on Day 1 and saline placebo on Day 29. Receives: Biological: Prevnar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Spontaneous and diary recorded events
Measured: 57 days
Geometric fold increase in IgG titre
Day 29 / Day 1 and Day 57/Day 1 geometric fold increase in IgG titre
Measured: 56 days
Secondary outcomes (4)
Geometric fold increase in OPA titre to 36 serotypes of S. pneumoniae
Day 29 / Day 1 and Day 57/Day 1 geometric fold increase in opsonophagocytic titre
Measured: 56 days
Geometric fold increase in IgA
Day 29 / Day 1 and Day 57/Day 1 geometric fold increase in serum and mucosal IgA
Measured: 56 days
Memory B cells
Memory B cell count
Measured: 56 days
Rate of community acquired pneumonia
Number of participants with community acquired pneumonia
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start26 Aug 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, PneumococcalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 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
- NCT06562790
- Sponsor's protocol ID
- GPNV-006
- Status last verified
- Aug 2024
- First submitted
- 18 Aug 2024
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomised, Active-controlled, Blinded, Dose-ranging Study of the Safety, Tolerability, and Immunogenicity of an Inactivated Whole-cell Pneumococcal Vaccine (Gamma-PN3) in Elderly Participants
- ClinicalTrials.gov ID
- NCT06562790
- Acronym / sponsor ID
- GPNV-006
- Conditions
- Pneumonia, Pneumococcal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- GPN VaccinesIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 20 Aug 2024 (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.
Phase 1 double- blind randomised active comparator dose escalating study of Gamma PN3 in the elderly
Detailed description
The study is a phase 1, randomised, active-controlled, double-blind sequential ascending-dose study to evaluate the safety, tolerability, and immunogenicity of Gamma-PN3 in elderly adults. Three sequential, ascending dose cohorts are planned, with 35 participants per cohort randomised to one of two treatment arms. Administration of allocated study treatments will be on Days 1 and 29, with one treatment arm consisting of two doses of Gamma-PN3, and the treatment arm consisting of the comparator vaccine Prevenar 13® (one dose only, with second dose of Placebo).
Immunogenicity will be assessed at Day 29 and Day 57
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gamma-PN3 | Experimental | Biological: Gamma PN32 doses on Days 1 and 29 |
| Prevnar | Active comparator | Biological: Prevnar1 dose on Day 1 and saline placebo on Day 29. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (16 listed)
- Male or female volunteers aged 70 years and over at Screening.
- In stable good general health as determined by the outcome of medical history, physical examination, and clinical judgement by the Investigator. Chronic stable non-inflammatory conditions such as hypertension, hyperlipidemia, well-controlled type 2 diabetes, stable asthma, controlled psychiatric conditions such as anxiety or depression, stable ischemic heart disease with heart failure not greater than NYHA Grade 1 and 2 are permitted, as determined by the Investigator.
- Willing and able to give voluntary written informed consent before screening assessments commence.
- Vital signs within the following ranges (inclusive):
- 12-lead ECG parameters within the following ranges:
Key exclusion criteria (16 listed)
- 1. History of a previous Pneumovax 23® vaccination in last 12 months. 2. History of a previous Prevenar 13® or Prevenar 20® vaccination in last 12 months.
- 3. Positive serology blood test for human immunodeficiency virus (HIV) antibodies, hepatitis B virus (HBV) surface antigen or Hepatitis C virus (HCV) antibodies. Positive serology to Hepatitis C due to previous successfully treated infection with negative polymerase chain reaction (PCR) is not exclusionary.
- 4. Infectious disease including but not limited to COVID-19 and influenza within 30 days before Screening and any time between Screening and Day 1 first dose, as this may confound immune response to study vaccine.
- 5. Liver function tests (including aspartate aminotransferase [AST], alanine aminotransferase [ALT], bilirubin) >1.5 upper limit of normal (ULN).
- 6. Clinically significant abnormalities in laboratory tests (biochemistry, haematology), physical examination, or 12-lead ECG during the Screening period that, in the opinion of the Investigator, would affect immune response to vaccination and/or ability to fully participate in the study and/or not be in the individual's best interest to participate in the study. One re-test per abnormality is permitted.
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 PN3500, 1000 or 1500 µg by IM injection on Days 1 and 29 | Biological | Gamma-PN3 |
| Prevnar1 dose on Day 1 and saline placebo on Day 29 | Biological | Prevnar |
Primary outcome
Adverse events
Time frame: 57 days
Spontaneous and diary recorded events
Geometric fold increase in IgG titre
Time frame: 56 days
Day 29 / Day 1 and Day 57/Day 1 geometric fold increase in IgG titre
4 secondary outcomes
Geometric fold increase in OPA titre to 36 serotypes of S. pneumoniae
Time frame: 56 days
Geometric fold increase in IgA
Time frame: 56 days
Memory B cells
Time frame: 56 days
Rate of community acquired pneumonia
Time frame: 1 year
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 11 May 2025.
- Individual participant dataSharing planned: No
Related trials for Pneumonia, Pneumococcal
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Active, not recruitingObservational study
A Study to Learn How Effective is PCV20 to Help Stop Adults Who Have a Higher Chance of Getting Pneumonia
Community-Acquired Pneumonia (CAP)
RecruitingObservational study
Pneumonia and Pleuropneumonia in Hospitalized Children
Pneumonia, Pleural Effusion
Active, not recruitingPhase 1
Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years
Pneumonia, Bacterial
RecruitingPhase 4
Opportunistic Pneumococcal Immunisation Trial in MALnutrition
Severe Acute Malnutrition in Childhood, Pneumococcal Disease
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 study testing Gamma PN3 and Prevnar in people with Pneumonia, Pneumococcal, 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 16 inclusion and 16 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 11 May 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?
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?
Adverse events (time frame: 57 days). 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 11 May 2025.