Vaccine study to assess the safety and immunogenicity of whole virus, alum-adjuvanted whole virus and virosomal A/HongKong/1073/99 (H9N2) vaccine in healthy adult volunteers
Conditions
Interventions
Product Name: Whole Virion A/HongKong/1073/99 (H9N2) vaccine
Product Code: WV
Pharmaceutical Form: Solution for injection
Other descriptive name: H9 haemagglutinin antigen
Concentration unit: µg micr
Sponsors
University Hospitals Leicester, Leicester General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Mentally competent adults, who have signed an informed consent form after having recieved a detailed explanation of the study protocol. b) Male or female subjects older than 18 and younger than 60 years who are either healthy or have a stable medical condition. c) Able to understand and comply with all study procedures and to complete study diaries. d) Individuals who can be contacted throughout the study and are available for all study visits. e) Females should either be using secure contraceptive precautions, be surgically sterilised or post-menopausal( defined as at least two years since the last menstrual period). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) 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. b) Individuals with a history of anaphylaxis or serious reactions to vaccines; hypersensitvity to eggs, chicken protein. chicken feathers, influenza viral protein, neomycin or polymixin, or products containing mercury. c) Persons with known immunosuppressive disease or who use systemic immunosuppressive drugs or ther 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 supress a chronic disease process, or have received in the last 6 months radiotherapy or chemotherapy. d) Subjects who are at high risk of developing illnesses of the immune system. e) Individuals who are taking immunostimulant therapy or interferon. f) Individuals who have received blood products or immunoglobulins parentally during the proceeding three months. g) Women should not be pregnant of lactating. h) Women who refuse to use a reliable contraceptive method throughout the study. i) Known or suspected drug abuse. j) Individuals who have received another vaccine or experimental ( investigational) drug in the preceding 4 weeks. k) Individuals who have previously received H9N2 vaccine. l) Unable to lead an independent life either physically or mentally. m) Regularly drink more than 40 units of alcohol weekly. n) Individuals who have had acute respiratory pathology or infections requiring systematic antibiotic or antiviral therapy during the preceding 7 days ( chronic antibiotic therapy for prevention of urinary tract infections is acceptable). o) Individuals who had a temperature > 38C in the preceeding 3 days. p) Individuals who, in the opinion of the investigator, have conditions that might complicate interpretation of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the immunogenicity of the following formulations of A/HongKong/1073/99 (H9N2) vaccine: a) Non-adjuvanted whole virion (WV) vaccine by intramuscular and intradermal administration b) alum-adjuvanted whole virion (WV) vaccine by intramuscular injection c) virosomal vaccine by intramuscular injection ;Secondary Objective: To determine the haemagglutinin (HA) antigenic content of influenza A/HongKong/1073/99 (H9N2) Whole virion vaccines required to produce a 'protective' antibody response in immunologically naive adult human populations. To identify whether one or two doses of vaccine are required to satisfy the licensing criteria. To examine the short term reactogenicity of the selected vaccines. To evaluate vaccine type and dose interactions.;Primary end point(s): The primary endpoint of the study is to assess each of the vaccine types with respect to the Committee for Human Medicinal Products (CPMP) licensing criteria for epidemic annual influenza vaccines. | — |
Countries
United Kingdom
Outcome results
None listed