Study of Gamma PN3 in the Elderly

NCT06562790 | Completed Phase 1 DMC

• 1 other identifier: GPNV-006
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1 double- blind randomised active comparator dose escalating study of Gamma PN3 in the elderly

Conditions

Pneumonia, Pneumococcal

Outcome Measures

Primary Outcomes (2)

• Adverse events

  Spontaneous and diary recorded events

  57 days

• Geometric fold increase in IgG titre

  Day 29 / Day 1 and Day 57/Day 1 geometric fold increase in IgG titre

  56 days

Secondary Outcomes (4)

• Geometric fold increase in OPA titre to 36 serotypes of S. pneumoniae

  56 days

• Geometric fold increase in IgA

  56 days

• Memory B cells

  56 days

• Rate of community acquired pneumonia

  1 year

Study Arms (2)

Gamma-PN3

EXPERIMENTAL

2 doses on Days 1 and 29

Biological: Gamma PN3

Prevnar

ACTIVE COMPARATOR

1 dose on Day 1 and saline placebo on Day 29.

Biological: Prevnar

Interventions

Gamma PN3 BIOLOGICAL

500, 1000 or 1500 µg by IM injection on Days 1 and 29

Gamma-PN3

Prevnar BIOLOGICAL

1 dose on Day 1 and saline placebo on Day 29

Prevnar

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.
• Respiratory rate 12 to 22 breaths per minute
• Systolic blood pressure 90 to 160 mmHg
• Diastolic blood pressure 50 to 95 mmHg
• 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.

You may not qualify if:

• \. 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.
• \. 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).
• \. 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.
• \. 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. 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.
• \. 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 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).
• \. A systemic inflammatory condition such as rheumatoid arthritis or inflammatory bowel disease.
• \. 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.
• \. 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.
• \. 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.
• \. Poor venous access making scheduled blood sampling likely to be unsuccessful

Sponsors & Collaborators

• GPN Vaccines: lead

Study Sites (1)

CMAX Fusion

Adelaide, South Australia, 5065, Australia

Location

MeSH Terms

Conditions

Pneumonia, Pneumococcal

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

Pneumococcal Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Bacterial; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: August 20, 2024
• Study Start: August 26, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: May 11, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)