U19 Influenza Immunity: Protective Mechanisms Against a Pandemic Respiratory Virus. Project 1: B-cell Immunity to Influenza
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- Stanford University
- Enrollment
- 18
- Primary Endpoint
- Number of Participants From Each Arm Who Received Influenza Vaccine
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of the study is to investigate and compare the human immune response in epithelial cells of the nasopharyngeal mucosa and in blood to live, attenuated influenza vaccine (LAIV) in adults and in children.
Detailed Description
The objective of the protocol is to investigate the human innate and adaptive immune responses in blood (only for adults) and nasopharyngeal mucosa resident cells to the live, attenuated influenza vaccine (LAIV) in both adults and children. The investigators hope to learn how the upper respiratory tract (URT) epithelial cells, the primary target of respiratory viruses, and the B cells and T cells, two major components of the immune system, respond to the influenza vaccine. The volunteers will be enrolled in two age groups: Group A: Up to 12 healthy non-twin volunteers, 2-8 years old, will be given seasonal LAIV. Each volunteer will complete a total of 3 visits. Volunteers will be divided in 2 sub-groups A-1 (n=6) and A-2 (n= 6) in order to collect nasopharyngeal swabs on different schedules (Day 1 or Day 2). Volunteers will be assigned to these sub-groups based on convenience sampling. Both sub-groups will complete the Day 0 and Day 28 visits and one visit at either Day 1 or Day 2 post-immunization. Specimens will include nasopharyngeal swabs collected at Day 1 for Sub-group A1 and Day 2 for Sub-group A-2, and Day 28 for both sub-groups. No blood samples will be collected in this age group. Children with no prior influenza vaccine history will receive a second dose of vaccine (LAIV) at least 28 days after the first study dose, according to the ACIP guidelines. Group B: Up to 18 healthy non-twin volunteers, 18-49 yrs old, will be given seasonal LAIV vaccine. Each volunteer will complete a total of 5 visits. Volunteers will be divided into 3 sub-groups B-1, B-2 and B-3 in order to collect nasopharyngeal swabs and blood specimens on different schedules (Day 0-6 hrs, Day 1 or Day 2). Volunteers will be assigned to these sub-groups based on convenience sampling. All sub-groups will complete visits at Day -7, Day 0 pre-immunization, Day 7 and Day 28 and 1 additional time point: Sub-group B-1 at Day 0, 6 hours post-immunization, Sub-group B-2 at Day 1 and Sub-group B-3 at Day 2. A nasopharyngeal swab will be collected at each visit except for Day 0 (baseline) and Day 7. A blood sample will be collected at each visit except Day -7
Investigators
Philip Grant
Assistant Professor of Medicine (Infectious Diseases)
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Otherwise healthy, ambulatory 2-8 years old (Group A) or 18-49 years old (Group B).
- •Willing to complete the informed consent process (including assent for minors 7 years old and above).
- •Availability for follow-up for the planned duration of the study at least 28 days after immunization.
- •Acceptable medical history by review of inclusion and exclusion criteria and vital signs.
Exclusion Criteria
- •Prior off-study vaccination with the current 2012-2013 seasonal TIV or LAIV.
- •Allergy to egg or egg products, or to vaccine components, including gentamicin, gelatin, arginine or MSG (LAIV)
- •Life-threatening reactions to previous influenza vaccinations
- •Asthma or history of wheezing
- •Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
- •History of immunodeficiency (including HIV infection)
- •Known or suspected impairment of immunologic function, including, but not limited to, clinically significant liver disease, diabetes mellitus treated with insulin, moderate to severe renal disease, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
- •Blood pressure \>150 systolic or \>95 diastolic at the first study visit and on the day of vaccination.
- •Hospitalization in the past year for congestive heart failure or emphysema.
- •Chronic Hepatitis B or C.
Outcomes
Primary Outcomes
Number of Participants From Each Arm Who Received Influenza Vaccine
Time Frame: Day 0 to 28
Secondary Outcomes
- Number of Participants With Related Adverse Events(Day 0 to 28 post-immunization)