NCT05667740

Safety, Tolerability and Immunogenicity of an Inactivated Whole-cell Pneumococcal Vaccine Gamma-PN3.

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: GPN Vaccines · Industry
• Sex: All
• Age: 50 Years – 69 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Pneumococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Gamma-PN3	Inactivated whole-cell pneumococcal vaccine
BIOLOGICAL	Prevenar-13	Licensed polysaccharide conjugate pneumococcal vaccine
BIOLOGICAL	Pneumovax-23	Licensed polysaccharide pneumococcal vaccine
DRUG	Placebo	Saline

Timeline

• Start date: 2023-01-16
• Primary completion: 2023-10-08
• Completion: 2023-10-08
• First posted: 2022-12-29
• Last updated: 2024-09-05

Locations

1 site across 1 country: Australia