NCT00814229

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
353

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 24, 2008

Completed
Last Updated

July 21, 2009

Status Verified

July 1, 2009

Enrollment Period

5 months

First QC Date

December 23, 2008

Last Update Submit

July 20, 2009

Conditions

Influenza

Keywords

influenzaH9N2vaccine

Outcome Measures

Primary Outcomes (1)

  • Geometric mean antibody titres of antibody to influenza H9 by HI and neutralising antibody assays

    Pre vaccination, 21 days and 42 days

Secondary Outcomes (2)

  • Local and systemic reactogenicity of influenza H9 vaccine

    within 7 days of vaccination

  • seroprotective antibody titres to influenza H9 by HI and neutralising antibody

    pre vacciantion, 21 and 42 days post-vaccine

Study Arms (14)

Vaccine 1

ACTIVE COMPARATOR

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

Biological: H9N2 whole virus vaccine, IM, 1.5microg

vaccine 2

ACTIVE COMPARATOR

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

Biological: H9N2 whole virus vaccine, IM, 5microg

Vaccine 3

ACTIVE COMPARATOR

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

Biological: H9N2 whole virus vaccine vaccine, IM, 15microg

Vaccine 4

ACTIVE COMPARATOR

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

Biological: H9N2 whole virus vaccine, IM, 45microg

Vaccine 5

ACTIVE COMPARATOR

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

Biological: H9N2 whole virus vaccine, alum, IM, 1.5microg

Vaccine 6

ACTIVE COMPARATOR

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

Biological: H9N2 whole virus, alum, IM, 5microg

Vaccine 7

ACTIVE COMPARATOR

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

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

Vaccine 8

ACTIVE COMPARATOR

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

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

Vaccine 9

ACTIVE COMPARATOR

influenza H9N2 vaccine virosomal containing 1.5microg haemagglutinin by intramuscular injection

Biological: H9N2 virosome vaccine, IM, 1.5microg

Vaccine 10

ACTIVE COMPARATOR

influenza H9N2 vaccine virosomal containing 5microg haemagglutinin by intramuscular injection

Biological: H9N2 virosomal vaccine, IM, 5microg

Vaccine 11

ACTIVE COMPARATOR

influenza H9N2 vaccine virosomal containing 15microg haemagglutinin by intramuscular injection

Biological: H9N2 virosomal vaccine, IM, 15microg

Vaccine 12

ACTIVE COMPARATOR

influenza H9N2 vaccine virosomal containing 45microg haemagglutinin by intramuscular injection

Biological: H9N2 virosomal vaccine, IM, 45microg

Vaccine 13

ACTIVE COMPARATOR

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

Biological: H9N2 whole virus vaccine, ID, 5microg

Vaccine 14

ACTIVE COMPARATOR

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

Biological: H9N2 whole virus vaccine, ID, 15microg

Interventions

H9N2 whole virus vaccine, IM, 1.5microgBIOLOGICAL

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

Vaccine 1
H9N2 whole virus vaccine, IM, 5microgBIOLOGICAL

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

vaccine 2
H9N2 whole virus vaccine vaccine, IM, 15microgBIOLOGICAL

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

Vaccine 3
H9N2 whole virus vaccine, IM, 45microgBIOLOGICAL

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

Vaccine 4
H9N2 whole virus vaccine, alum, IM, 1.5microgBIOLOGICAL

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

Vaccine 5
H9N2 whole virus, alum, IM, 5microgBIOLOGICAL

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

Vaccine 6
H9N2 vaccine, whole virus, alum, IM, 15 microgBIOLOGICAL

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

Vaccine 7
H9N2 vaccine, whole virus, alum, IM, 45microgBIOLOGICAL

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

Vaccine 8
H9N2 virosome vaccine, IM, 1.5microgBIOLOGICAL

influenza H9N2 vaccine virosomal containing 1.5microg haemagglutinin by intramuscular injection

Vaccine 9
H9N2 virosomal vaccine, IM, 5microgBIOLOGICAL

influenza H9N2 vaccine virosome containing 5microg haemagglutinin by intramuscular injection

Vaccine 10
H9N2 virosomal vaccine, IM, 15microgBIOLOGICAL

influenza H9N2 vaccine virosome containing 15microg haemagglutinin by intramuscular injection

Vaccine 11
H9N2 virosomal vaccine, IM, 45microgBIOLOGICAL

influenza H9N2 vaccine virosome containing 45microg haemagglutinin by intramuscular injection

Vaccine 12
H9N2 whole virus vaccine, ID, 5microgBIOLOGICAL

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

Vaccine 13
H9N2 whole virus vaccine, ID, 15microgBIOLOGICAL

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

Vaccine 14

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mentally competent adults, who have signed an informed consent form after having received a detailed explanation of the study protocol.
  • Male or female subjects over 18 years who are either healthy or have a stable medical condition.
  • Able to understand and comply with all study procedures and to complete study diaries
  • Individuals who can be contacted throughout the study and are available for all study visits
  • Females should either be using secure contraceptive precautions including a) the oral contraceptive pill, b) condom/barrier contraception c) partner has had a vasectomy, d) be surgically sterilised, or e) post- (defined as at least two years since the last menstrual period)

You may not qualify if:

  • Any clinically significant concurrent illness or unstable medical condition including: malignant tumours, autoimmune illnesses (including rheumatoid arthritis), acute or progressive renal or hepatic pathology, chronic obstructive pulmonary disease requiring oxygen therapy, and any active neurological disorder.
  • Individuals with a history of anaphylaxis or serious reactions to vaccines; hypersensitivity to eggs, chicken protein, chicken feathers, influenzal viral protein, neomycin or polymixin, or products containing mercury.
  • Persons with known immunosuppressive disease or who use systemic immunosuppressive drugs or other drugs listed in section 8 of the British National Formulary (BNF) or chloroquine, gold or penicillamine or other drugs listed in section 10.1.3 of the BNF to suppress a chronic disease process, or have received in the last 6 months radiotherapy or chemotherapy.
  • Subjects who are at high risk of developing illnesses of the immune system.
  • Individuals who are taking immunostimulant therapy or interferon
  • Individuals who have received blood products or immunoglobulins parenterally during the preceding three months.
  • Women should not be pregnant or lactating.
  • Women who refuse to use a reliable contraceptive method throughout the study
  • Known or suspected drug abuse.
  • Individuals who have received another vaccine or experimental (investigational) drug in the preceding 4 weeks.
  • Individuals who have previously received H9N2 vaccine
  • Unable to lead an independent life either physically or mentally
  • Regularly drink more than 40 units of alcohol weekly
  • Individuals who have had acute respiratory pathology or infections requiring systemic antibiotic or antiviral therapy during the preceding 7 days (chronic antibiotic therapy for prevention of urinary tract infections is acceptable).
  • Individuals who had a temperature over 38 degrees C in the preceding 3 days.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leicester

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

aluminum sulfate

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Karl G Nicholson, FRCP, MD

    University of Leicester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 23, 2008

First Posted

December 24, 2008

Study Start

August 1, 2007

Primary Completion

January 1, 2008

Study Completion

September 1, 2008

Last Updated

July 21, 2009

Record last verified: 2009-07

Locations

GB(1)