Clinical Study to Evaluate Antibody and Cell Mediated Immunity of A/H1N1 Influenza Vaccine in Healthy Subjects
|Influenza||Biological: egg-derived A/H1N1 pandemic influenza vaccine||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||An Open-Label Exploratory Clinical Study to Evaluate the Antibody and Cell Mediated Immunity of One Intramuscular Dose of MF59-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects Aged 18 to 60 Years|
- Antibody and cell mediated immune responses to one 0.50 mL IM injection of egg-derived Focetria™ pandemic influenza vaccine in terms of quality and quantity of the antigen-specific T- and B-cell response [ Time Frame: On day 8, 22, 202 after vaccination ]
Cell Mediated Immunity (CMI) assessed by frequencies and fold increases of antigen-specific CD4+ T-cells and B-lymphocytes on Day 0,8,22,202.
Immunogenicity, i.e. Haemagglutination Inhibition (HI), Single Radial Haemolysis (SRH) and Microneutralization (MN), assessed as follows:
- Geometric mean titer (GMT)/Geometric mean area (GMA) on Day 0,8,22,202.
- Geometric mean ratio (GMR) at each time-point vs. Day 0.
- Percentage of subjects achieving seroconversion or significant increase on Day 8,22,202.
- Percentage of subjects with HI (or MN) titer≥40 and SRH≥25 mm2 on Day 0,8,22,202.
- Antibody responses to one injection of egg-derived Focetria™ pandemic influenza vaccine according to CHMP criteria [ Time Frame: On day 8, 22, 202 after vaccination ]
In the interpretation of HI immunogenicity results, the following Committee for Medicinal Products for Human Use (CHMP) criteria (CPMP/BWP/214/96) for healthy adults will be taken in consideration:
- The proportion of subjects achieving seroconversion or significant increase in HI antibody titer should be > 40%
- Mean geometric increase should be > 2.5
- The proportion of subjects achieving an HI titer ≥ 40 should be > 70%.
- Safety and tolerability [ Time Frame: Within 30 minutes after vaccination (Day 0) and on day 8, 22 and 202 after vaccination ]A medical history will be obtained and physical assessment performed for each subject entered into the study at the time of enrolment and then, a brief physical assessment after every subsequent visit. All subjects will be followed for safety throughout the study. All serious adverse events and all adverse events will be collected throughout the entire trial using diary cards.
|Study Start Date:||December 2009|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Vaccine
All Subjects enrolled in this study will receive the study vaccine (single-arm)
Biological: egg-derived A/H1N1 pandemic influenza vaccine
One 0.50 mL IM dose injection (7.5 µg of vaccine + 9.75 mg MF59)
Other Name: Focetria™
This will be a Phase IV open-label clinical profiling study. The population to be enrolled will consist of healthy adults aged 18-60 years. A total of approximately 60 subjects are planned for enrolment into this study.
Subjects enrolled in this study will receive 7.5 µg of vaccine + MF59 (9.75 mg/dose). Each subject will receive one 0.5 mL IM dose (deltoid muscle, non-dominant arm) of H1N1sw vaccine at Visit 1, after the blood draw. Up to 70 mL of blood will be drawn for CMI and antibody assessment from all subjects at all study visits.
Subjects will be requested to declare occurrence of influenza-related symptoms during the study period. Whenever appropriate, subjects might be asked to provide throat swab for viral typing. Subjects with laboratory confirmed H1N1sw influenza might be asked to provide one blood sample (70 mL) within 4 weeks after influenza resolution.
Although this study is not designed nor powered to draw conclusions regarding safety and tolerability, all subjects will be followed, but not analyzed, for safety throughout the study. After vaccination, all subjects will remain under medical supervision at the study site for 30 minutes to be monitored and evaluated for possible immediate hypersensitivity reactions. All study subjects will be instructed on the completion of diary cards to record local and systemic reactions for seven days, starting on the day of vaccination and continuing during the 6 following days. The same diary cards will additionally be used to collect any vaccine-related reactions and any changes in the subject's health (including any serious medical problems such as hospitalizations or any life-threatening medical problems) and any medications taken by the subject throughout the study. All serious adverse events and all adverse events will be recorded throughout the entire trial.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079273
|Azienda Ospedaliera Universtaria Senese|
|Siena, Italy, 53100|
|Principal Investigator:||Franco Laghi Pasini, MD||Azienda Ospedaliera Universitaria Senese|
|Study Chair:||Laura Michellini||Opera Srl|
|Study Director:||Fabio Montanaro, DSc||Opera Srl|