Research sponsor: GPN Vaccines Pty Ltd
Research site: North Terrace, Adelaide
Lead Researcher: Dr Thomas Polasek
HREC: This study has been reviewed and approved by the Bellberry Human Research Ethics Committee (Project ID: GPNV-008)

Bacterial pneumonia remains one of the world’s leading causes of preventable death, taking over a million lives each year. While current vaccines protect against only a small number of bacterial subtypes, researchers are working toward a potential breakthrough – a new vaccine called Gamma-PN designed to protect against many more.

By taking part in this study, you can help researchers refine testing methods that will show how well this new vaccine works. Your participation could play an important role in the future of pneumonia prevention – helping protect communities and saving lives worldwide.

• Participants will be compensated for participating in this study.
• Participants may experience a temporary boost in their immunity to pneumococcal infection.
• Participants will be contributing valuable information that may benefit society in the future.
• Participants will be helping to advance medical research.

• You will receive a detailed outline of all details of the study, including risks and procedures, and you will be given the chance to ask study staff questions before you decide whether to participate.
• If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time
• Your records relating to this study and any other information received will be kept strictly confidential, except as required by law.

Who Can Participate:

• Must be aged 25-69
• Must not have previously received a licensed or experimental pneumococcal vaccine.
• Must have no positive blood test for HIV, Hepatitis B, or Hepatitis C.
• Must not have had any infectious disease (including COVID-19 or influenza) within 30 days prior to screening.
• Must not have participated in another clinical study or received any investigational product, vaccine, drug, or medical procedure in the past 4 weeks.
• Must not be pregnant, planning pregnancy, or breastfeeding during the study period.
• Must be able to participate in 3 study visits over 1 month.

Who Cannot Participate:

• Must not have received a live vaccine within the last 3 months or any other vaccine within the last 28 days.
• Must not have received blood or blood products in the past 3 months.
• Must not have immunodeficiency, recent cancer therapy (past 6 months), long-term corticosteroid use, or steroid injections within 3 months.
• Must not have certain chronic or systemic conditions, including severe heart failure, uncontrolled asthma or diabetes, severe psychiatric conditions, chronic kidney disease requiring dialysis, or systemic inflammatory conditions (e.g., rheumatoid arthritis, inflammatory bowel disease).
• Must not have a history of severe allergic reactions to any medicine or vaccines, severe or repeated fainting during blood draws, or any condition that prevents attending study visits or completing study procedures.

The study team will explain the research in its entirety, but some details include:

• Participants will be asked to attend a screening visit to review the study details, provide written consent, and complete health checks and lab tests to confirm eligibility.
• Participants will be asked to receive a single study injection (Gamma-PN or placebo) on Day 1, stay briefly for monitoring, complete a Day 8 phone check-in, and return around Day 29 for follow-up blood tests.
• Participants will be asked to provide blood samples and undergo routine safety assessments, including vital signs, ECG, and lab tests, so researchers can evaluate immune response and ensure participant safety.

GPN Vaccines Pty Ltd
GPN Vaccines Pty Ltd is an Australian biotechnology company focused on developing Gamma-PN, a universal vaccine to protect against all strains of Streptococcus pneumoniae. This bacterium causes serious diseases like pneumonia, meningitis, and sepsis, and current vaccines only protect against a limited number of strains. Gamma-PN aims to provide broader protection for both children and adults.