Safety and Immunogenicity of A/H1N1v Vaccines in Healthy Adults
Safety and Immunogenicity of A/H1N1v Vaccines in Healthy Adults
The purpose of this study is to evaluate the antibody response to one and two doses of
 influenza A/H1N1v vaccine in healthy adults.
An observer-blind, single-centre study in which 7 groups of 25-30 male and female adults
 ≥18-50 years of age will be randomly allocated to receive two doses of cell culture
 non-adjuvanted or MF59-adjuvanted influenza A/California/4/2009 (H1N1) surface antigen
 vaccine containing 3.75, 7.5 or 15µg haemagglutinin by intramuscular injection. A second dose
 of the same vaccine containing the same quantity of antigen as in the first dose will be
 administered 21 days later. Three additional groups will receive two doses of MF59-adjuvanted
 influenza A/California/4/2009 (H1N1) surface antigen vaccine containing 7.5 µg haemagglutinin
 by intramuscular injection on day 0 or separated by 7 or 14 days. Subjects will be observed
 for local and systemic reactions for 30 minutes after each immunisation and will be monitored
 for any reactions and other adverse events for 7 days after each immunisation.
Inclusion Criteria:

 1. Mentally competent adults, who have signed an informed consent form after having
 received a detailed explanation of the study protocol.

 2. Male or female subjects 18-50 years who are either healthy or have a stable medical
 condition.

 3. Able to understand and comply with all study procedures and to complete study diaries

 4. Individuals who can be contacted throughout the study and are available for all study
 visits

 5. Females should either be using secure contraceptive precautions including:

 -  the oral contraceptive pill

 -  condom/barrier contraception

 -  partner has had a vasectomy

 -  be surgically sterilised, or

 -  post-menopausal (defined as at least two years since the last menstrual period)

 Exclusion Criteria:

 1. 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.

 2. Individuals with a history of anaphylaxis or serious reactions to vaccines;
 hypersensitivity to influenzal viral protein, neomycin or polymixin, or products
 containing mercury.

 3. 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.

 4. Subjects who are at high risk of developing illnesses of the immune system.

 5. Individuals who are taking immunostimulant therapy or interferon

 6. Individuals who have received blood products or immunoglobulins parenterally during
 the preceding three months.

 7. Women should not be pregnant or lactating.

 8. Women who refuse to use a reliable contraceptive method throughout the study

 9. Known or suspected drug abuse.

 10. Individuals who have received another vaccine or investigational medicinal product in
 the preceding 2 weeks.

 11. Unable to lead an independent life either physically or mentally

 12. Regularly drink more than 40 units of alcohol weekly

 13. 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).

 14. Individuals who had a temperature >38oC in the preceding 3 days.

 15. Individuals who, in the opinion of the investigator, have conditions that might
 complicate interpretation of the study results.

 16. Individuals who have had confirmed pandemic influenza H1 infection