Influenza Clinical Trial
Official title:
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
| Status | Completed |
| Enrollment | 353 |
| Est. completion date | September 2008 |
| Est. primary completion date | January 2008 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | University Hospitals Leicester | Leicester | Leicestershire |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospitals, Leicester | Crucell Holland BV, National Institute of Biological Standards and Control, Public Health England |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Geometric mean antibody titres of antibody to influenza H9 by HI and neutralising antibody assays | Pre vaccination, 21 days and 42 days | No | |
| Secondary | Local and systemic reactogenicity of influenza H9 vaccine | within 7 days of vaccination | Yes | |
| Secondary | seroprotective antibody titres to influenza H9 by HI and neutralising antibody | pre vacciantion, 21 and 42 days post-vaccine | No |
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