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

Pneumococcal Infections Clinical Trial

Official title:
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

Clinical Trial Summary

This is a randomised placebo-controlled first-in-man dose-ranging study to determine safety and markers of efficacy.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05667740
Study type Interventional
Source GPN Vaccines
Contact Tim Hirst, PhD
Phone +61 420 942 824
Email tim@gpnvaccines.com
Status Recruiting
Phase Phase 1
Start date January 16, 2023
Completion date September 30, 2023
View Details
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