Influenza
Conditions
Keywords
Quadrivalent, inactivated influenza vaccine, Quadrivalent, live, attenuated influenza vaccine, Identical twin adults
Brief summary
The purpose of this study is provide a better understanding of the adaptive immune response to the licensed flu vaccines. The investigators hope the information learned from this study will help identify and describe important factors of influenza immunity especially of or specific proteins associated with the T-cell immune response.
Detailed description
This is a study of up to 20 healthy monozygotic (MZ) twins, 18-49 years old, that are participants from past Stanford-LPCH Vaccine Program trials and who have been identified as human leukocyte antigen (HLA) DR1501+ or DR0701+ by lab assay results. Volunteers will be contacted to assess interest in participating in this study. Both twins in the pair must be willing to participate in the study. All participants will be randomized within the twin pair to receive either the seasonal live, attenuated influenza vaccine (LAIV) or the seasonal quadrivalent inactivated influenza vaccine (IIV4). Immunization will be at Day 0, blood samples for immunogenicity assays will be collected prior to immunization and at Days 7 (6-8) and 28 (24-32). This study was halted due to the Advisory Committee on Immunization Practices decision not to recommend use of LAIV.
Interventions
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
1. Otherwise healthy 18-49 years old identical (MZ) twins identified as DR1501+ or DR0701+ by lab assay results. Both twins in the pair must be willing to participate in the study. 2. Willing to complete the informed consent process 3. Availability for follow-up for the planned duration of the study 4. Acceptable medical history by review of inclusion/
Exclusion criteria
and vital signs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Received Influenza Vaccine | Day 0 | Number of individual twins who received either LAIV or IIV4 as dictated by their group assignment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Related Adverse Events | Day 0 to 28 post-immunization | Number of individual twins who experienced related adverse events through the course of the study. |
Countries
United States
Participant flow
Recruitment details
Volunteers are past participants who are identical twins and who have been identified as HLA DR1501+ or DR0701+ by lab assay results.
Pre-assignment details
All participants will be randomized within the twin pair to receive either the seasonal quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® or the seasonal quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® .
Participants by arm
| Arm | Count |
|---|---|
| LAIV Randomized Individual twins are past participants who have been identified as HLA DR1501+ or DR0701+ by lab assay results. All participants will be randomized within the twin pair to receive either the seasonal quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® or the seasonal quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® .
FluMist®: FluMist® Intranasal Spray (quadrivalent, live, attenuated influenza vaccine) | 5 |
| IIV4 Randomized Individual twins are past participants who have been identified as HLA DR1501+ or DR0701+ by lab assay results. All participants will be randomized within the twin pair to receive either the seasonal quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® or the seasonal quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone®
Fluzone®: Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine) | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | IIV4 Randomized | LAIV Randomized | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 10 Participants |
| Age, Continuous | 46 years STANDARD_DEVIATION 9.79 | 46 years STANDARD_DEVIATION 9.79 | 46 years STANDARD_DEVIATION 9.23 |
| Region of Enrollment United States | 5 participants | 5 participants | 10 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Number of Participants Who Received Influenza Vaccine
Number of individual twins who received either LAIV or IIV4 as dictated by their group assignment
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LAIV Randomized | Number of Participants Who Received Influenza Vaccine | 5 Participants |
| IIV4 Randomized | Number of Participants Who Received Influenza Vaccine | 5 Participants |
Secondary
Number of Participants With Related Adverse Events
Number of individual twins who experienced related adverse events through the course of the study.
Time frame: Day 0 to 28 post-immunization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LAIV Randomized | Number of Participants With Related Adverse Events | 0 Participants |
| IIV4 Randomized | Number of Participants With Related Adverse Events | 0 Participants |