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Study of Gamma PN3 in the Elderly
Phase 1 double- blind randomised active comparator dose escalating study of Gamma PN3 in the elderly.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 70 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-08-26
Primary completion: 2025-06-01
Study completion finish: 2026-06-01
Study type
PREVENTION
Phase
PHASE1
Trial ID
NCT06562790
Intervention or treatment
BIOLOGICAL: Gamma PN3
BIOLOGICAL: Prevnar
Conditions
- • Pneumonia, Pneumococcal
Find a site
Closest Location:
CMAX Fusion
Research sites nearby
Select from list below to view details:
CMAX Fusion
Adelaide, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Gamma-PN3
| BIOLOGICAL: Gamma PN3
|
ACTIVE_COMPARATOR: Prevnar
| BIOLOGICAL: Prevnar
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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 outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
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 | 56 days |
Geometric fold increase in IgA | Day 29 / Day 1 and Day 57/Day 1 geometric fold increase in serum and mucosal IgA | 56 days |
Memory B cells | Memory B cell count | 56 days |
Rate of community acquired pneumonia | Number of participants with community acquired pneumonia | 1 year |
Frequently Asked Questions
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