Safety and Immunogenicity of Influenza H9 Vaccine in Humans

Summary

H9N2 influenza circulates in animal and poultry and has caused delf limiting infections in children. Influenza H9N2 poses a pandemic threat to humans.

This study evaluates the safety and immunogenicity of adjuvanted and non-adjuvanted whole virus and virosomal H9N2 vaccines by the intramuscular route. We also assess intradermal route of administration to see if this has any advantages. The aim is to assess antibody responses before and after vaccination. The hypothesis is that lower doses of adjuvanted vaccine will induce similar antibody responses to non-adjuvanted vaccine

Conditions

• Influenza

Interventions

BIOLOGICAL

H9N2 whole virus vaccine, IM, 1.5microg

influenza H9N2 vaccine whole virus containing 1.5microg haemagglutinin by intramuscular injection

BIOLOGICAL

H9N2 whole virus vaccine, IM, 5microg

influenza H9N2 vaccine whole virus containing 5microg haemagglutinin by intramuscular injection

BIOLOGICAL

H9N2 whole virus vaccine vaccine, IM, 15microg

influenza H9N2 vaccine whole virus containing 15microg haemagglutinin by intramuscular injection

BIOLOGICAL

H9N2 whole virus vaccine, IM, 45microg

influenza H9N2 vaccine whole virus containing 45microg haemagglutinin by intramuscular injection

BIOLOGICAL

H9N2 whole virus vaccine, alum, IM, 1.5microg

influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 1.5microg haemagglutinin by intramuscular injection

BIOLOGICAL

H9N2 whole virus, alum, IM, 5microg

influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 5microg haemagglutinin by intramuscular injection

BIOLOGICAL

H9N2 vaccine, whole virus, alum, IM, 15 microg

influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 15microg haemagglutinin by intramuscular injection

BIOLOGICAL

H9N2 vaccine, whole virus, alum, IM, 45microg

influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 45microg haemagglutinin by intramuscular injection

BIOLOGICAL

H9N2 virosome vaccine, IM, 1.5microg

influenza H9N2 vaccine virosomal containing 1.5microg haemagglutinin by intramuscular injection

BIOLOGICAL

H9N2 virosomal vaccine, IM, 5microg

influenza H9N2 vaccine virosome containing 5microg haemagglutinin by intramuscular injection

BIOLOGICAL

H9N2 virosomal vaccine, IM, 15microg

influenza H9N2 vaccine virosome containing 15microg haemagglutinin by intramuscular injection

BIOLOGICAL

H9N2 virosomal vaccine, IM, 45microg

influenza H9N2 vaccine virosome containing 45microg haemagglutinin by intramuscular injection

BIOLOGICAL

H9N2 whole virus vaccine, ID, 5microg

influenza H9N2 vaccine whole virus containing 5microg haemagglutinin by intradermal injection

BIOLOGICAL

H9N2 whole virus vaccine, ID, 15microg

influenza H9N2 vaccine whole virus containing 15microg haemagglutinin by intradermal injection

Sponsors & Collaborators

• Crucell Holland BV

  collaborator INDUSTRY

• National Institute of Biological Standards and Control

  collaborator OTHER_GOV

• Public Health England

  collaborator OTHER_GOV

• University Hospitals, Leicester

  lead OTHER

Principal Investigators

• Karl G Nicholson, FRCP, MD · University of Leicester

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-08-31

Primary Completion

2008-01-31

Completion

2008-09-30

Countries

• United Kingdom

Study Locations