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

NCT02335164 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2019-05-07

No results posted yet for this study

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

Conditions

Interventions

BIOLOGICAL

recombinant influenza hemagglutinin

recombinant influenza hemagglutinin

BIOLOGICAL

Advax1

Delta inulin adjuvant formulation 1

BIOLOGICAL

Advax2

Delta inulin adjuvant formulation 2

Sponsors & Collaborators

  • Flinders University

    collaborator OTHER

  • Australian Respiratory and Sleep Medicine Institute

    collaborator OTHER

  • Vaxine Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Dimitar Sajkov, FRACP, PhD · Flinders University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2017-12-01
Completion
2019-05-01

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02335164 on ClinicalTrials.gov