Influenza
Conditions
Keywords
Influenza vaccines, healthy participants, immunity to influenza, identical twins, fraternal twins, non-twins
Brief summary
This study will compare influenza vaccine responses in monozygotic and dizygotic twins.
Detailed description
The investigators plan to study the response to different influenza vaccines much more broadly and deeply across different age groups and with different vaccine modalities and to probe the influence of genetics on these responses using monozygotic and dizygotic twins.
Interventions
BIOLOGICALFluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza vaccine (IIV3)
BIOLOGICALFluMist® (intranasal)
Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
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
8 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
1. Otherwise healthy, ambulatory children or adults, ages 8-17 years (identical twin pairs), 18-30 years (identical or fraternal twin pairs), 40-49 years (identical or fraternal twin pairs) or 70-100 years (twin or non-twin adults). 2. Willing to complete the informed consent process. 3. Availability for follow-up for the planned duration of the study at least 28 days after immunization. 4. Acceptable medical history and vital signs. 5. Negative urine pregnancy test for women of childbearing potential 6. If the subject is female and of childbearing potential, she must use an acceptable method of contraception and not become pregnant for the duration of the study. (Acceptable contraception includes implants, injectables, combined oral contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner).
Exclusion criteria
1. Prior vaccination with TIV or LAIV in Fall 2009 2. Allergy to egg or egg products, or to vaccine components, including gentamicin, gelatin, arginine or MSG (for LAIV only), or thimerosal (TIV multidose vials only). 3. Life-threatening reactions to previous influenza vaccinations 4. Asthma (LAIV groups only) 5. Active systemic or serious concurrent illness, including febrile illness on the day of vaccination 6. History of immune deficiency 7. 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, blood pressure \>150/95 at screening, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol. 8. Hospitalization in the past year for congestive heart failure or emphysema. 9. Chronic Hepatitis B or C 10. Recent or current use of immunosuppressive medication, including glucocorticoids (corticosteroid nasal sprays are permissible). 11. Subjects in close contact with anyone who has a severely weakened immune system should not receive LAIV. 12. Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia). 13. Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol. 14. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year 15. Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin, Plavix, Aggrenox may be acceptable after review by investigator. 16. Receipt of blood or blood products within the past 6 months 17. Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol 18. Inactivated vaccine 14 days prior to vaccination 19. Live, attenuated vaccine within 60 days of vaccination 20. History of Guillain-Barre Syndrome 21. Pregnant or lactating woman 22. Use of investigational agents within 30 days prior to enrollment 23. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment 24. Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants From Each Arm Who Received Influenza Vaccine Vaccine | Day 0 to 28 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Related Adverse Events | Day 0 to 28 post-immunization |
Other
| Measure | Time frame | Description |
|---|---|---|
| Lymphocyte Response to Influenza Immunization | Day 6-28 post-immunization | Compare lymphocyte responses at Days 6-14 and the lymphocyte and serology responses at Day 28 post-immunization following annual administration of the influenza vaccines |
Countries
United States
Participant flow
Recruitment details
Numbers listed in the tables reflect individual twins and not twin pairs.
Participants by arm
| Arm | Count |
|---|---|
| Group A: Age 8-17 yo Identical Twins (Fluzone) Participants will be randomized to receive Fluzone® (intramuscular) | 6 |
| Group A: Age 8-17 yo Identical Twins (FluMist) Participants will be randomized to receive FluMist® (intranasal) | 6 |
| Group B: Age 18-30 yo Identical Twins Participants to receive FluMist® (intranasal) | 8 |
| Group C: Age 18-30 yo Fraternal Twins Participants to receive FluMist® (intranasal) | 6 |
| Group D: Age 40-49 yo Identical Twins Participants to receive FluMist® (intranasal) | 6 |
| Group E: Age 40-49 yo Fraternal Twins Participants to receive FluMist® (intranasal) | 6 |
| Group F: 70-100 yo Identical Twins Participants to receive Fluzone® (intramuscular) | 10 |
| Group G: 70-100 yo Nontwins Participants to receive Fluzone® (intramuscular) | 24 |
| Total | 72 |
Baseline characteristics
| Characteristic | Total | Group A: Age 8-17 yo Identical Twins (FluMist) | Group A: Age 8-17 yo Identical Twins (Fluzone) | Group B: Age 18-30 yo Identical Twins | Group C: Age 18-30 yo Fraternal Twins | Group D: Age 40-49 yo Identical Twins | Group E: Age 40-49 yo Fraternal Twins | Group F: 70-100 yo Identical Twins | Group G: 70-100 yo Nontwins |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 12 Participants | 6 Participants | 6 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 34 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 10 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 0 Participants | 0 Participants | 8 Participants | 6 Participants | 6 Participants | 6 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 68 Participants | 6 Participants | 6 Participants | 6 Participants | 4 Participants | 6 Participants | 6 Participants | 10 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 65 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 2 Participants | 10 Participants | 23 Participants |
| Sex: Female, Male Female | 42 Participants | 2 Participants | 2 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 18 Participants |
| Sex: Female, Male Male | 30 Participants | 4 Participants | 4 Participants | 4 Participants | 2 Participants | 2 Participants | 2 Participants | 6 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 6 | 0 / 8 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 10 | 0 / 24 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 8 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 10 | 0 / 24 |
Outcome results
Primary
Number of Participants From Each Arm Who Received Influenza Vaccine Vaccine
Time frame: Day 0 to 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A: Age 8-17 yo Identical Twins (IM) | Number of Participants From Each Arm Who Received Influenza Vaccine Vaccine | 6 Participants |
| Group A: Age 8-17 yo Identical Twins (IN) | Number of Participants From Each Arm Who Received Influenza Vaccine Vaccine | 6 Participants |
| Group B: 18-30 yo Identical Twins | Number of Participants From Each Arm Who Received Influenza Vaccine Vaccine | 8 Participants |
| Group C: 18-30 yo Fraternal Twins | Number of Participants From Each Arm Who Received Influenza Vaccine Vaccine | 6 Participants |
| Group D: 40-49 yo Identical Twins | Number of Participants From Each Arm Who Received Influenza Vaccine Vaccine | 6 Participants |
| Group E: 40-49 yo Fraternal Twins | Number of Participants From Each Arm Who Received Influenza Vaccine Vaccine | 6 Participants |
| Group F: 70-100 yo Twins | Number of Participants From Each Arm Who Received Influenza Vaccine Vaccine | 10 Participants |
| Group G: 70-100 yo Non-twins | Number of Participants From Each Arm Who Received Influenza Vaccine Vaccine | 24 Participants |
Secondary
Number of Participants With Related Adverse Events
Time frame: Day 0 to 28 post-immunization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A: Age 8-17 yo Identical Twins (IM) | Number of Participants With Related Adverse Events | 0 Participants |
| Group A: Age 8-17 yo Identical Twins (IN) | Number of Participants With Related Adverse Events | 0 Participants |
| Group B: 18-30 yo Identical Twins | Number of Participants With Related Adverse Events | 0 Participants |
| Group C: 18-30 yo Fraternal Twins | Number of Participants With Related Adverse Events | 0 Participants |
| Group D: 40-49 yo Identical Twins | Number of Participants With Related Adverse Events | 0 Participants |
| Group E: 40-49 yo Fraternal Twins | Number of Participants With Related Adverse Events | 0 Participants |
| Group F: 70-100 yo Twins | Number of Participants With Related Adverse Events | 0 Participants |
| Group G: 70-100 yo Non-twins | Number of Participants With Related Adverse Events | 0 Participants |
Other Pre-specified
Lymphocyte Response to Influenza Immunization
Compare lymphocyte responses at Days 6-14 and the lymphocyte and serology responses at Day 28 post-immunization following annual administration of the influenza vaccines
Time frame: Day 6-28 post-immunization