Influenza
Conditions
Keywords
Trivalent, inactivated influenza vaccine, Live, attenuated influenza vaccine, Nasopharyngeal swabs, Young adults
Brief summary
This study will examine the immune responses to the seasonal influenza vaccine in single cells of the nasal passages when compared with cells in circulating blood.
Detailed description
Using state-of-the-art technology, the investigators hope the information learned from this study will help identify and describe important factors in the early-stage development of influenza immunity and possibly lead to the development of more effective vaccines. This study will be conducted in healthy male and female volunteers 18-30 years of age who received one of two seasonal influenza vaccine types, intramuscular standard trivalent inactivated influenza vaccine (TIV) or live, attenuated influenza vaccine (LAIV) given by intranasal spray. Participants are divided into two groups. The control group will receive the 2012-2013 formulation of the standard intramuscular trivalent inactivated influenza vaccine (TIV). A blood sample and nasopharyngeal swab samples (one from each nostril) will be collected at a single visit, Day 0. For those in the live, attenuated influenza vaccine (LAIV) group, at the first visit, they will receive a single administration of the 2012-2013 formulation of LAIV. At the second study visit two days later, they will provide a blood sample and two nasopharyngeal swab samples (one from each nostril).
Interventions
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
1. Otherwise healthy, ambulatory adult between the ages of 18-30 years 2. Willing to complete the informed consent process. 3. Availability for follow-up at Day 2 (LAIV Group only) 4. Acceptable medical history by review of inclusion/
Exclusion criteria
and vital signs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants From Each Arm Who Received Influenza Vaccine | Day 0 to 28 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Related Adverse Events | Day 0 to 28 post-immunization |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TIV/ Control Group Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.
Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection | 4 |
| LAIV Group Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray | 8 |
| Total | 12 |
Baseline characteristics
| Characteristic | TIV/ Control Group | Total | LAIV Group |
|---|---|---|---|
| Age, Continuous | 23.99 years STANDARD_DEVIATION 2.955 | 24.40 years STANDARD_DEVIATION 4.45 | 24.60 years STANDARD_DEVIATION 5.22 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 12 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 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 | 1 Participants | 4 Participants | 3 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 | 3 Participants | 8 Participants | 5 Participants |
| Region of Enrollment United States | 4 participants | 12 participants | 8 participants |
| Sex: Female, Male Female | 1 Participants | 6 Participants | 5 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 0 / 8 |
| serious Total, serious adverse events | 0 / 3 | 0 / 8 |
Outcome results
Primary
Number of Participants From Each Arm Who Received Influenza Vaccine
Time frame: Day 0 to 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TIV/ Control Group | Number of Participants From Each Arm Who Received Influenza Vaccine | 3 Participants |
| LAIV Group | Number of Participants From Each Arm Who Received Influenza Vaccine | 8 Participants |
Secondary
Number of Participants With Related Adverse Events
Time frame: Day 0 to 28 post-immunization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TIV/ Control Group | Number of Participants With Related Adverse Events | 0 Participants |
| LAIV Group | Number of Participants With Related Adverse Events | 0 Participants |