Protective Mechanisms Against a Pandemic Respiratory Virus. Project 1: B-cell Immunity to Influenza. Technical Development Project 1: Measuring the Immunome: Genomic Approaches to B-cell Repertoire - Years 2 (2010) & 3 (2011)
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- Stanford University
- Enrollment
- 91
- Primary Endpoint
- Number of Participants Who Received Influenza Vaccine
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
In this exploratory study, investigators will be looking at immune response differences between age groups and between the two different influenza vaccines given to identical twins, vaccine-naive young adults and elderly participants.
Detailed Description
This is an exploratory study of healthy children and adults who are given either standard trivalent, inactivated influenza vaccine (TIV) or live, attenuated influenza vaccine (LAIV). There are no exclusions for gender, ethnicity or race. Following confirmation of written informed consent, baseline blood samples will be drawn from all study participants prior to immunization. The volunteers enrolled in any the three groups (A,B,C) cannot have been immunized with previous year's seasonal influenza vaccine. The identical twins in Groups A will be randomized to each receive a different vaccine (TIV or LAIV) than their twin. The non-twin children in Group B will also be randomly assigned to receive either TIV or LAIV. Non-twin elderly adults in Group C will be given standard TIV. All participants will receive a single dose of their assigned influenza vaccine, either by intramuscular (IM) injection (TIV) or intranasal application (LAIV).
Investigators
Cornelia L. Dekker
Study Principal Investigator
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Healthy, ambulatory 8-17 year old identical twins, 8-30 year old non-twins, or 70-100 year old elderly non-twin adults.
- •Willing to complete the informed consent process.
- •Availability for follow-up for the planned duration of the study at least 28 days after immunization.
- •Acceptable medical history by medical history and vital signs.
Exclusion Criteria
- •Prior vaccination with seasonal TIV or LAIV or H1N
- •Prior off-study vaccination with the current seasonal TIV or LAIV
- •Allergy to egg or egg products, or to vaccine components
- •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 first study visit
- •Hospitalization in the past year for congestive heart failure or emphysema.
Outcomes
Primary Outcomes
Number of Participants 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)