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H5-VLP + GLA-AF Vaccine Trial in Healthy Adult Volunteers

NCT01657929 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2014-02-26

No results posted yet for this study

Summary

The purpose of this study is to determine the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of pandemic influenza. The vaccine, identified as H5-VLP + GLA-AF, consists of a recombinant influenza virus H5 protein (hemagglutinin from A/Indonesia/5/2005) produced in a plant-based expression system assembling into virus-like particles together with the adjuvant GLA-AF.

Conditions

  • Influenza A Subtype H5N1 Infection

Interventions

BIOLOGICAL

H5-VLP + GLA-AF

H5-VLP antigen and GLA-AF adjuvant. 2 injections at Days 0, and 21.

BIOLOGICAL

H5-VLP alone

H5-VLP antigen alone. 2 injections at Days 0, and 21.

BIOLOGICAL

H5-VLP + Alhydrogel(R)

H5-VLP antigen and Alhydrogel(R) adjuvant. 2 injections at Days 0, and 21.

BIOLOGICAL

Licensed H5N1 vaccine

Licensed H5N1 vaccine. 2 injections given on Days 0 and 21.

Sponsors & Collaborators

  • Medicago

    collaborator INDUSTRY

  • Defense Advanced Research Projects Agency

    collaborator FED

  • Access to Advanced Health Institute (AAHI)

    lead OTHER

Principal Investigators

  • Franco Piazza, MD, MPH · Access to Advanced Health Institute (AAHI)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States

Study Locations

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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 NCT01657929 on ClinicalTrials.gov