- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00814229
Safety and Immunogenicity of Influenza H9 Vaccine in Humans
Randomised Dose Ranging Observer Blind Single Centre Study to Evaluate Safety and Immunogenicity of Adjuvanted and Non-adjuvanted Influenza H9 Influenza Vaccine in Humans
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
Study Overview
Status
Conditions
Intervention / Treatment
- Biological: H9N2 whole virus vaccine, IM, 1.5microg
- Biological: H9N2 whole virus vaccine, IM, 5microg
- Biological: H9N2 whole virus vaccine vaccine, IM, 15microg
- Biological: H9N2 whole virus vaccine, IM, 45microg
- Biological: H9N2 whole virus vaccine, alum, IM, 1.5microg
- Biological: H9N2 whole virus, alum, IM, 5microg
- Biological: H9N2 vaccine, whole virus, alum, IM, 15 microg
- Biological: H9N2 vaccine, whole virus, alum, IM, 45microg
- Biological: H9N2 virosome vaccine, IM, 1.5microg
- Biological: H9N2 virosomal vaccine, IM, 5microg
- Biological: H9N2 virosomal vaccine, IM, 15microg
- Biological: H9N2 virosomal vaccine, IM, 45microg
- Biological: H9N2 whole virus vaccine, ID, 5microg
- Biological: H9N2 whole virus vaccine, ID, 15microg
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Leicestershire
-
Leicester, Leicestershire, United Kingdom, LE1 5WW
- University Hospitals Leicester
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
- Individuals who, in the opinion of the investigator, have conditions that might complicate interpretation of the study results.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Vaccine 1
influenza H9N2 vaccine whole virus containing 1.5microg haemagglutinin by intramuscular injection
|
influenza H9N2 vaccine whole virus containing 1.5microg haemagglutinin by intramuscular injection
|
ACTIVE_COMPARATOR: vaccine 2
influenza H9N2 vaccine whole virus containing 5microg haemagglutinin by intramuscular injection
|
influenza H9N2 vaccine whole virus containing 5microg haemagglutinin by intramuscular injection
|
ACTIVE_COMPARATOR: Vaccine 3
influenza H9N2 vaccine whole virus containing 15microg haemagglutinin by intramuscular injection
|
influenza H9N2 vaccine whole virus containing 15microg haemagglutinin by intramuscular injection
|
ACTIVE_COMPARATOR: Vaccine 4
influenza H9N2 vaccine whole virus containing 45microg haemagglutinin by intramuscular injection
|
influenza H9N2 vaccine whole virus containing 45microg haemagglutinin by intramuscular injection
|
ACTIVE_COMPARATOR: Vaccine 5
influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 1.5microg haemagglutinin by intramuscular injection
|
influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 1.5microg haemagglutinin by intramuscular injection
|
ACTIVE_COMPARATOR: Vaccine 6
influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 5microg haemagglutinin by intramuscular injection
|
influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 5microg haemagglutinin by intramuscular injection
|
ACTIVE_COMPARATOR: Vaccine 7
influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 15microg haemagglutinin by intramuscular injection
|
influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 15microg haemagglutinin by intramuscular injection
|
ACTIVE_COMPARATOR: Vaccine 8
influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 45microg haemagglutinin by intramuscular injection
|
influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 45microg haemagglutinin by intramuscular injection
|
ACTIVE_COMPARATOR: Vaccine 9
influenza H9N2 vaccine virosomal containing 1.5microg haemagglutinin by intramuscular injection
|
influenza H9N2 vaccine virosomal containing 1.5microg haemagglutinin by intramuscular injection
|
ACTIVE_COMPARATOR: Vaccine 10
influenza H9N2 vaccine virosomal containing 5microg haemagglutinin by intramuscular injection
|
influenza H9N2 vaccine virosome containing 5microg haemagglutinin by intramuscular injection
|
ACTIVE_COMPARATOR: Vaccine 11
influenza H9N2 vaccine virosomal containing 15microg haemagglutinin by intramuscular injection
|
influenza H9N2 vaccine virosome containing 15microg haemagglutinin by intramuscular injection
|
ACTIVE_COMPARATOR: Vaccine 12
influenza H9N2 vaccine virosomal containing 45microg haemagglutinin by intramuscular injection
|
influenza H9N2 vaccine virosome containing 45microg haemagglutinin by intramuscular injection
|
ACTIVE_COMPARATOR: Vaccine 13
influenza H9N2 vaccine whole virus containing 5microg haemagglutinin by intradermal injection
|
influenza H9N2 vaccine whole virus containing 5microg haemagglutinin by intradermal injection
|
ACTIVE_COMPARATOR: Vaccine 14
influenza H9N2 vaccine whole virus containing 15microg haemagglutinin by intradermal injection
|
influenza H9N2 vaccine whole virus containing 15microg haemagglutinin by intradermal injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Geometric mean antibody titres of antibody to influenza H9 by HI and neutralising antibody assays
Time Frame: Pre vaccination, 21 days and 42 days
|
Pre vaccination, 21 days and 42 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Local and systemic reactogenicity of influenza H9 vaccine
Time Frame: within 7 days of vaccination
|
within 7 days of vaccination
|
seroprotective antibody titres to influenza H9 by HI and neutralising antibody
Time Frame: pre vacciantion, 21 and 42 days post-vaccine
|
pre vacciantion, 21 and 42 days post-vaccine
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHL 08162
- REC 6794
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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