Influenza
Conditions
Brief summary
This is one project of a larger ongoing study related to the immune system's response to the flu virus. This study is designed to investigate the immune response to the live attenuated influenza vaccine (LAIV) vs. the Inactivated Influenza Vaccine (IIV) in identical and fraternal twins.
Detailed description
This is a Phase I mechanistic study of licensed influenza vaccines. The study requires 10 monozygotic and 10 dizygotic sets of twins (40 total participants) to enroll. The duration of the study for an individual volunteer will be 4 weeks including screening and active participation. The study has a total of 3 visits. First visit: Procedures during this visit are: Informed consent process, enrollment, study assessments, 20 ml blood draw, and vaccination. Participants will be randomized to receive either LAIV or IIV. The time required to complete the first study visit will be about 30-40 minutes. 2nd (day 7 post vaccination) and 3rd (day 28 post vaccination ) visit: 20 ml blood will be obtained and the visit will take approximately 15 minutes.
Interventions
BIOLOGICALLive attenuated influenza vaccine (LAIV4)
LAIV4 vaccine dosage is 0.2 mL. The vaccine will be administered as an intranasal spray. Each sprayer contains a single dose of FluMist® Quadrivalent; approximately one-half of the contents should be administered into each nostril. 0.1 mL (i.e., half of the dose from a single FluMist sprayer) is administered into each nostril while the recipient is in an upright position. Insert the tip of the sprayer just inside the nose and rapidly depress the plunger until the dose-divider clip stops the plunger. The dose-divider clip is removed from the sprayer to administer the second half of the dose (0.1 mL) into the other nostril.
BIOLOGICALInactivated Influenza Vaccine (IIV4)
IIV4 vaccine will be administered as a 0.5 mL dose, with a sterile, disposable syringe and needle by IM injection.
Sponsors
National Institutes of Health (NIH)
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
2 Years to 20 Years
Healthy volunteers
Yes
Inclusion criteria
1. 2-20 year old male and female patients 2. Willing and able to complete the informed consent process 3. Availability of twin pair also agreeable and eligible for study inclusion 4. Availability for follow-up for the planned duration of the study 5. Acceptable medical history by review of inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HAI Titers | Day 28 | Evaluate HAI titers in response to influenza vaccination. An HAI titer is a hemoglobin assay that correlates to protection from influenza infection; an HAI titer of 40 or greater is considered to be protective. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Inactivated Influenza Vaccine (IIV) Participants were randomized to received IIV | 9 |
| Live Attenuated Influenza Vaccine 4 (LAIV 4) The other twin set was randomized to the LAIV4 | 9 |
| Total | 18 |
Baseline characteristics
| Characteristic | Inactivated Influenza Vaccine (IIV) | Live Attenuated Influenza Vaccine 4 (LAIV 4) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 9 Participants | 9 Participants | 18 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 9 Participants | 18 Participants |
| Region of Enrollment United States | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 |
Outcome results
Primary
HAI Titers
Evaluate HAI titers in response to influenza vaccination. An HAI titer is a hemoglobin assay that correlates to protection from influenza infection; an HAI titer of 40 or greater is considered to be protective.
Time frame: Day 28
Population: Data were not collected for this outcome measure.