NCT06562790

Study of Gamma PN3 in the Elderly

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: GPN Vaccines · Industry
• Sex: All
• Age: 70 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Pneumonia, Pneumococcal

Interventions

Type	Name	Description
BIOLOGICAL	Gamma PN3	500, 1000 or 1500 µg by IM injection on Days 1 and 29
BIOLOGICAL	Prevnar	1 dose on Day 1 and saline placebo on Day 29

Timeline

• Start date: 2024-08-26
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2024-08-20
• Last updated: 2025-05-11

Locations

1 site across 1 country: Australia