T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 4, 2012
Primary Purpose
Influenza
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
TIV
High-Dose TIV
LAIV
Sponsored by
About this trial
This is an interventional basic science trial for Influenza focused on measuring Inactivated influenza vaccine, Live, attenuated influenza vaccine, Adult and elderly identical twins, Adult fraternal twins
Eligibility Criteria
Inclusion Criteria:
- Otherwise healthy, ambulatory adults, ages 18-30 years (identical or fraternal twin pairs), 40-64 years (identical or fraternal twin pairs) or 65-100 years (identical twin pairs).
- 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 and vital signs.
Exclusion Criteria:
- Prior off-study vaccination with trivalent inactivated influenza vaccine (TIV) or live attenuated influenza vaccine (LAIV) in Fall 2012
- Allergy to egg or egg products, or to vaccine components (including gentamicin, gelatin, arginine or MSG (LAIV for Group B only), and thimerosal (if TIV multidose vials used)
- Life-threatening reactions to previous influenza vaccinations
- Active systemic or serious concurrent illness, including febrile illness 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 Visit 1
- Hospitalization in the past year for congestive heart failure or emphysema.
- Chronic Hepatitis B or C
- Recent or current use of immunosuppressive medication, including glucocorticoids (corticosteroid nasal sprays, topical steroids and inhaled steroids are permissible). Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable after review by the investigator.
- 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).
- 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.
- History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
- Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except aspirin up to 325 mg.day), Plavix, or Aggrenox must be reviewed by investigator to determine if this would affect the volunteer's safety.
- Receipt of blood or blood products within the past 6 months or planned receipt of blood products prior to completion of study visits.
- Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
- Receipt of inactivated vaccine 14 days prior to study vaccination, or planned non-study vaccination prior to completion of Visit 03 (~Day 28 after the study vaccination)
- Receipt of live, attenuated vaccine within 60 days of vaccination, or planned non-study vaccination prior to completion of Visit 03 (~Day 28 after the study vaccination)
- Need for allergy immunization (that cannot be postponed) during the study period V01 to V03 (~Day 28)
- History of Guillain-Barre Syndrome
- Pregnant or lactating woman
- Use of investigational agents within 30 days prior to enrollment or planned use of investigational agents prior to completion of study visits.
- Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or planned blood donation prior to completion of Visit 03 ( ~28 Day after study vaccination)
- A current member of the clinical study team.
- 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.
- Asthma or history of wheezing (for Group B volunteers only)
- Participants in close contact with anyone who has a severely weakened immune system should not receive LAIV (for Group B volunteers only)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Other
Other
Other
Other
Other
Arm Label
Group B: 18-30 yo identical twins (LAIV)
Group B: 18-30 yo identical twins (TIV)
Group D: 40-64 yo identical twins (TIV)
Group F: 65-100 yo identical twins (TIV)
Group F: 65-100 yo identical twins (High-Dose TIV)
Arm Description
Participants to receive FluMist® LAIV by nasal spray.
Participants to receive Fluzone® standard TIV
Participants to receive Fluzone® standard TIV
Participants to receive Fluzone® standard TIV
Participants to receive High-Dose Fluzone® standard TIV
Outcomes
Primary Outcome Measures
Number of Participants Who Received Influenza Vaccine
Secondary Outcome Measures
Number of Participants With Related Adverse Events
Full Information
NCT ID
NCT03022435
First Posted
January 12, 2017
Last Updated
May 18, 2017
Sponsor
Stanford University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT03022435
Brief Title
T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 4, 2012
Official Title
Protective Mechanisms Against a Pandemic Respiratory Virus: B-cell, T-cell, and General Immune Response to Seasonal Influenza Vaccine. Year 4, 2012
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2012 (Actual)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will investigate markers, mechanisms and define general predictors for immunological health by comparing 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. On an investigational basis, the investigators plan to compare various immunological responses, identify age-specific biomarkers or clusters of markers, quantify the frequency of influenza-specific T-cells pre- and post-vaccination, and determine the effective breadth of T-cell repertoire to an influenza vaccine within an individual as a function of age and to what degree this is genetically determined.
Twin group B will will be randomly assigned to receive a single dose of inactivated vaccine, either the trivalent inactivated influenza vaccine (TIV) or intranasal live, attenuated influenza vaccine (LAIV). Twin Groups C-E will receive a single administration of TIV. Group F, elderly participants, will be randomly assigned to receive a single dose of inactivated vaccine, either the standard dose or the high-dose TIV. Blood samples to conduct the assays described will be taken at pre-immunization, Days 7-10 and 28 post-immunization.
Groups A, C and E were not enrolled for this year of the five year annual study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Inactivated influenza vaccine, Live, attenuated influenza vaccine, Adult and elderly identical twins, Adult fraternal twins
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group B: 18-30 yo identical twins (LAIV)
Arm Type
Other
Arm Description
Participants to receive FluMist® LAIV by nasal spray.
Arm Title
Group B: 18-30 yo identical twins (TIV)
Arm Type
Other
Arm Description
Participants to receive Fluzone® standard TIV
Arm Title
Group D: 40-64 yo identical twins (TIV)
Arm Type
Other
Arm Description
Participants to receive Fluzone® standard TIV
Arm Title
Group F: 65-100 yo identical twins (TIV)
Arm Type
Other
Arm Description
Participants to receive Fluzone® standard TIV
Arm Title
Group F: 65-100 yo identical twins (High-Dose TIV)
Arm Type
Other
Arm Description
Participants to receive High-Dose Fluzone® standard TIV
Intervention Type
Biological
Intervention Name(s)
TIV
Other Intervention Name(s)
Fluzone® standard TIV
Intervention Description
Influenza Virus Vaccine Suspension for Intramuscular Injection
Intervention Type
Biological
Intervention Name(s)
High-Dose TIV
Other Intervention Name(s)
High-Dose Fluzone® TIV
Intervention Description
High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe
Intervention Type
Biological
Intervention Name(s)
LAIV
Other Intervention Name(s)
FluMist®
Intervention Description
Live, attenuated influenza vaccine for Intranasal Spray
Primary Outcome Measure Information:
Title
Number of Participants Who Received Influenza Vaccine
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Number of Participants With Related Adverse Events
Time Frame
Day 0 to 28 post-immunization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Otherwise healthy, ambulatory adults, ages 18-30 years (identical or fraternal twin pairs), 40-64 years (identical or fraternal twin pairs) or 65-100 years (identical twin pairs).
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 and vital signs.
Exclusion Criteria:
Prior off-study vaccination with trivalent inactivated influenza vaccine (TIV) or live attenuated influenza vaccine (LAIV) in Fall 2012
Allergy to egg or egg products, or to vaccine components (including gentamicin, gelatin, arginine or MSG (LAIV for Group B only), and thimerosal (if TIV multidose vials used)
Life-threatening reactions to previous influenza vaccinations
Active systemic or serious concurrent illness, including febrile illness 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 Visit 1
Hospitalization in the past year for congestive heart failure or emphysema.
Chronic Hepatitis B or C
Recent or current use of immunosuppressive medication, including glucocorticoids (corticosteroid nasal sprays, topical steroids and inhaled steroids are permissible). Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable after review by the investigator.
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).
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.
History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except aspirin up to 325 mg.day), Plavix, or Aggrenox must be reviewed by investigator to determine if this would affect the volunteer's safety.
Receipt of blood or blood products within the past 6 months or planned receipt of blood products prior to completion of study visits.
Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
Receipt of inactivated vaccine 14 days prior to study vaccination, or planned non-study vaccination prior to completion of Visit 03 (~Day 28 after the study vaccination)
Receipt of live, attenuated vaccine within 60 days of vaccination, or planned non-study vaccination prior to completion of Visit 03 (~Day 28 after the study vaccination)
Need for allergy immunization (that cannot be postponed) during the study period V01 to V03 (~Day 28)
History of Guillain-Barre Syndrome
Pregnant or lactating woman
Use of investigational agents within 30 days prior to enrollment or planned use of investigational agents prior to completion of study visits.
Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or planned blood donation prior to completion of Visit 03 ( ~28 Day after study vaccination)
A current member of the clinical study team.
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.
Asthma or history of wheezing (for Group B volunteers only)
Participants in close contact with anyone who has a severely weakened immune system should not receive LAIV (for Group B volunteers only)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cornelia Dekker, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Davis, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Garry Nolan, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ann Arvin, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen Quake, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25246558
Citation
Kay AW, Fukuyama J, Aziz N, Dekker CL, Mackey S, Swan GE, Davis MM, Holmes S, Blish CA. Enhanced natural killer-cell and T-cell responses to influenza A virus during pregnancy. Proc Natl Acad Sci U S A. 2014 Oct 7;111(40):14506-11. doi: 10.1073/pnas.1416569111. Epub 2014 Sep 22.
Results Reference
background
PubMed Identifier
25203448
Citation
O'Gorman WE, Huang H, Wei YL, Davis KL, Leipold MD, Bendall SC, Kidd BA, Dekker CL, Maecker HT, Chien YH, Davis MM. The Split Virus Influenza Vaccine rapidly activates immune cells through Fcgamma receptors. Vaccine. 2014 Oct 14;32(45):5989-97. doi: 10.1016/j.vaccine.2014.07.115. Epub 2014 Sep 6.
Results Reference
background
PubMed Identifier
25740957
Citation
Kay AW, Bayless NL, Fukuyama J, Aziz N, Dekker CL, Mackey S, Swan GE, Davis MM, Blish CA. Pregnancy Does Not Attenuate the Antibody or Plasmablast Response to Inactivated Influenza Vaccine. J Infect Dis. 2015 Sep 15;212(6):861-70. doi: 10.1093/infdis/jiv138. Epub 2015 Mar 4.
Results Reference
background
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T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 4, 2012
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