drugset / Trial / NCT02335164

A Phase 1 Study to Evaluate the Immunogenicity and Safety of a Pandemic Avian Influenza Vaccine in Adults

NCT02335164

RandomizedParallel-groupTriple-blindPrevention

Summary

Recombinant hemagglutinin has been shown to induce protective neutralising antibodies against avian influenza virus but is relatively non-immunogenic. An ideal pandemic avian influenza influenza vaccine would combine hemagglutinin antigen with an appropriate adjuvant to increase its immunogenicity. This Phase 1 study will collect preliminary human safety and efficacy data on combined formulations of recombinant hemagglutinin with Advax adjuvant formulations administered by intramuscular injection

Timeline

Start
2015-07
Primary completion
2017-12-01
Completion
2019-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Advax1 Other / unclassified 20 mg Intramuscular
Subject Advax2 Other / unclassified 20 mg Intramuscular
Subject Panblok H7 Vaccine 2.5 ug Intramuscular
Subject Panblok H7 Vaccine 5 ug Intramuscular
Subject Panblok H7 Vaccine 15 ug Intramuscular
Subject Panblok H7 Vaccine 45 ug Intramuscular

Indications