Pneumococcal InfectionsPhase 1NCT05667740
Safety, Tolerability and Immunogenicity of an Inactivated Whole-cell Pneumococcal Vaccine Gamma-PN3.
A Phase 1 study testing Gamma-PN3, Prevenar-13 and Pneumovax-23 in people with Pneumococcal Infections, run by GPN Vaccines at 1 site in Australia.
Trial summary
This is a randomised placebo-controlled first-in-man dose-ranging study to determine safety and markers of efficacy. Read more about this study
- Who is it for?
- Ages 50 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections
- What is being tested?
- Gamma-PN3, Prevenar-13 and Pneumovax-23
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteAustralia
- Study dates
- 16 Jan 2023to 8 Oct 2023
- 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 50 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female volunteers aged 50 to 69 years inclusive at Screening.
- In good 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 without heart failure 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
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- Respiratory rate 12 to 22 breaths per minute
- Systolic blood pressure 90 to 160 mmHg
- Diastolic blood pressure 50 to 95 mmHg
- 12-lead electrocardiogram (ECG) parameters within the following ranges:
- QTcB \& QTcF - males ≤450 msec. females ≤470 msec
- PR 100 to 240 msec inclusive
- HR 50 to 100 bpm inclusive
- 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) as per State Health advice at the time of recruitment.
Who cannot join
- History of a previous Pneumovax 23® vaccination.
- History of a previous Prevenar 13® vaccination.
- Splenectomy or cochlear implant, due to likelihood of having received pneumococcal vaccination at age less than 70 years.
- Positive serology blood test for human immunodeficiency virus (HIV) antibodies, hepatitis B virus (HBV) surface antigen or Hepatitis C virus (HCV) antibodies.
- 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.
- Liver function tests (including aspartate aminotransferase [AST], alanine aminotransferase [ALT], bilirubin) >1.5 upper limit of normal (ULN).
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- Clinically significant abnormalities in laboratory tests (biochemistry, haematology, coagulation, urinalysis), physical examination, 12-lead ECG or vital signs 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 retest per abnormality is permitted.
- 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.
- Plan to have a vaccine during the study period including COVID-19 booster.
- 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, 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.
- Have received blood or blood-derived products in the last three months before screening, which might interfere with assessment of the immune response.
- 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 or equivalent for more than two consecutive weeks within the last month before screening, depot or intraarticular steroids within 3 months before screening).
- A systemic inflammatory condition such as rheumatoid arthritis or inflammatory bowel disease.
- History of severe allergic reaction e.g., severe cutaneous adverse reaction or anaphylaxis to any medicinal product or to any of the study products, including excipients.
- 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 are not exclusionary if 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).
- 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, COAD with breathlessness interfering with daily activities; psychiatric conditions, poorly controlled asthma, or diabetes
- Any chronic medical condition e.g., asthma, gout, which is likely to need systemic corticosteroid therapy during the study. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomised, Placebo-controlled, Double-blind, Sequential Ascending-dose Study to Evaluate the Safety, Tolerability, and Immunogenicity of an Inactivated Whole-cell Pneumococcal Vaccine (Gamma-PN3) in Healthy Adults
This is a randomised placebo-controlled first-in-man dose-ranging study to determine safety and markers of efficacy.
Read the detailed description
The study is of double-blind; parallel groups dose escalation design. In each cohort of 39 participants 30 will receive Gamma-PN3; 3 will receive Prevenar; 3 will receive Pneumovax and 3 saline placebo.
The doses of Gamma-PN3 will be 50mcg; 250 mcg and 1000 mcg of protein content.
- Conditions
- Pneumococcal Infections
- Being tested
- Gamma-PN3, Prevenar-13, Pneumovax-23, 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
Inactivated whole-cell pneumococcal vaccine
Prevenar-13Biological
Licensed polysaccharide conjugate pneumococcal vaccine
Pneumovax-23Biological
Licensed polysaccharide pneumococcal vaccine
PlaceboDrug
Saline
| Study group | Role | What they receive |
|---|---|---|
| Gamma-PN3 | Experimental | Inactivated whole-cell pneumococcal vaccine at 50, 250 or 1000 mcg of protein content.
One dose on Day 1 and second dose Day 29 Receives: Biological: Gamma-PN3 |
| Placebo | Placebo comparator | Saline on Day 1 and second dose Day 29 Receives: Drug: Placebo |
| Prevenar-13 | Active comparator | Licensed pneumococcal vaccine on Day 1 and saline on Day 29 Receives: Biological: Prevenar-13 |
| Pneumovax-23 | Active comparator | Licensed pneumococcal vaccine on Day 1 and saline on Day 29 Receives: Biological: Pneumovax-23 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events and clinical laboratory measures
Safety
Measured: 57 days
Immunogenicity
Frequency of participants with > 4 fold increase in IgG titre at 29 and 57 days.
Measured: 57 days
Secondary outcomes (1)
OPKA response
Opsonophagocytic antibodies effective against different serotypes of Streptococcus pneumoniae will be assessed at Days 29 and 57
Measured: 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start16 Jan 2023
- Primary completion8 Oct 2023
- Study completion8 Oct 2023
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- GPN Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sepehr Shakib, MD, Principal investigator, CMAX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667740
- Sponsor's protocol ID
- GPNV-001
- Status last verified
- Feb 2023
- First submitted
- 19 Dec 2022
- Last updated
- 5 Sep 2024
- 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 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomised, Placebo-controlled, Double-blind, Sequential Ascending-dose Study to Evaluate the Safety, Tolerability, and Immunogenicity of an Inactivated Whole-cell Pneumococcal Vaccine (Gamma-PN3) in Healthy Adults
- ClinicalTrials.gov ID
- NCT05667740
- Acronym / sponsor ID
- GPNV-001
- Conditions
- Pneumococcal Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- GPN VaccinesIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 8 Oct 2023 (actual)
- Study completion
- 8 Oct 2023 (actual)
- First posted
- 29 Dec 2022 (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.
This is a randomised placebo-controlled first-in-man dose-ranging study to determine safety and markers of efficacy.
Detailed description
The study is of double-blind; parallel groups dose escalation design. In each cohort of 39 participants 30 will receive Gamma-PN3; 3 will receive Prevenar; 3 will receive Pneumovax and 3 saline placebo.
The doses of Gamma-PN3 will be 50mcg; 250 mcg and 1000 mcg of protein content.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Gamma-PN3 | Experimental | Biological: Gamma-PN3Inactivated whole-cell pneumococcal vaccine at 50, 250 or 1000 mcg of protein content. One dose on Day 1 and second dose Day 29 |
| Placebo | Placebo comparator | Drug: PlaceboSaline on Day 1 and second dose Day 29 |
| Prevenar-13 | Active comparator | Biological: Prevenar-13Licensed pneumococcal vaccine on Day 1 and saline on Day 29 |
| Pneumovax-23 | Active comparator | Biological: Pneumovax-23Licensed pneumococcal vaccine on Day 1 and saline on Day 29 |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female volunteers aged 50 to 69 years inclusive at Screening.
- In good 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 without heart failure 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 electrocardiogram (ECG) parameters within the following ranges:
Key exclusion criteria (17 listed)
- History of a previous Pneumovax 23® vaccination.
- History of a previous Prevenar 13® vaccination.
- Splenectomy or cochlear implant, due to likelihood of having received pneumococcal vaccination at age less than 70 years.
- Positive serology blood test for human immunodeficiency virus (HIV) antibodies, hepatitis B virus (HBV) surface antigen or Hepatitis C virus (HCV) antibodies.
- 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.
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-PN3Inactivated whole-cell pneumococcal vaccine | Biological | Gamma-PN3 |
| Prevenar-13Licensed polysaccharide conjugate pneumococcal vaccine | Biological | Prevenar-13 |
| Pneumovax-23Licensed polysaccharide pneumococcal vaccine | Biological | Pneumovax-23 |
| PlaceboSaline | Drug | Placebo |
Primary outcome
Adverse events and clinical laboratory measures
Time frame: 57 days
Safety
Immunogenicity
Time frame: 57 days
Frequency of participants with > 4 fold increase in IgG titre at 29 and 57 days.
1 secondary outcome
OPKA response
Time frame: 57 days
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 5 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Sepehr Shakib, MD principal investigator
CMAX
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, Prevenar-13 and Pneumovax-23 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 16 inclusion and 17 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 5 Sep 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 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 and clinical laboratory measures (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 5 Sep 2024.