B-cell Immunity to Influenza (SLVP017)- Year 5, 2013
Primary Purpose
Influenza
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Fluzone
Sponsored by
About this trial
This is an interventional basic science trial for Influenza focused on measuring Trivalent inactivated influenza vaccine, Young children, Young adults
Eligibility Criteria
Inclusion Criteria:
- Healthy, ambulatory children 1-2 years of age or 18-30 year-old young adults.
- Willing to complete the informed consent process.
- Availability for follow-up for the planned duration of the study (after last study immunization, approximately 8 weeks for Group A and 4 weeks for Group B).
- Acceptable medical history by medical history and vital signs.
Exclusion Criteria:
- Group A: Prior vaccination with a seasonal flu vaccine (IIV). Group B: Prior vaccination with the 2012-2013 seasonal flu vaccine (IIV or LAIV).
- Prior off-study vaccination with the current 2013-2014 seasonal IIV or LAIV
- Allergy to egg or egg products, or to vaccine components.
- Life-threatening reactions to previous influenza vaccinations
- Active systemic or serious concurrent illness, including febrile illness on 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.
- Chronic Hepatitis B or C.
- Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible; use of inhaled steroids, or 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 up to 325 mg. per 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
- Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
- Inactivated vaccine within 14 days prior to study vaccination (inform study staff of any non-study vaccinations received during study period)
- Live, attenuated vaccine within 30 days prior to first study vaccination, or planned immunization with a live, attenuated vaccine before completion of study visits (inform study staff of any non-study vaccinations received during study period).
- Need for allergy immunizations (that cannot be rescheduled if necessary) during the study period
- 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
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group A: 1-2 years old
Group B: 18-30 years old
Arm Description
Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).
Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.
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
NCT03020537
First Posted
January 11, 2017
Last Updated
May 7, 2018
Sponsor
Stanford University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT03020537
Brief Title
B-cell Immunity to Influenza (SLVP017)- Year 5, 2013
Official Title
U19 Influenza Immunity: Protective Mechanisms Against a Pandemic Respiratory Virus. Project 1: B-cell Immunity to Influenza. Technical Development Project 1: Measuring the Immunome: Genomic Approaches to B-cell Repertoire- Year 5, 2013
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 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
In this exploratory study, investigators will be looking at immune response differences between age groups and between the two different vaccines given to identical twins and vaccine-naive young adults.
Detailed Description
This is a study of healthy children and adults who will be given standard seasonal influenza vaccination (IIV3). There are no exclusions for gender, ethnicity or race. Following review and confirmation of written informed consent, volunteers will be enrolled into the study.
The 1-2 year-old child volunteers enrolled in Group A cannot have been previously immunized with an influenza vaccine. They will receive two single doses of the 2013-2014 pediatric formulation of seasonal trivalent inactivated influenza vaccine (IIV3), at least 28 days apart, given by intramuscular (IM) injection. The child volunteers will complete 4 clinic visits with 3 blood sample collections. Study visits will be on Day 0 (first immunization), Day 28-32 (second immunization), Day 6-8 post-Dose 2, and Day 28+4 post-Dose 2. The baseline blood sample will be drawn prior to immunization at Day 0, followed by two additional blood samples at Day 6-8 post-Dose 2, and Day 28+4 post-Dose 2. There will not be a blood sample collected at Day 28-32.
The 18-30 year-old young adults in Group B cannot have been immunized with the 2012-2013 seasonal influenza vaccine. Participants in Group B will receive a single dose of the 2013-2014 IIV3 by IM injection. Young adult volunteers will complete 3 clinic visits with 3 blood sample collections on Day 0, Day 6-8, and Day 28+4. The baseline blood sample will be drawn prior to immunization at Day 0.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Trivalent inactivated influenza vaccine, Young children, Young adults
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A: 1-2 years old
Arm Type
Other
Arm Description
Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).
Arm Title
Group B: 18-30 years old
Arm Type
Other
Arm Description
Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.
Intervention Type
Biological
Intervention Name(s)
Fluzone
Intervention Description
Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.
Primary Outcome Measure Information:
Title
Number of Participants Who Received Influenza Vaccine
Time Frame
Day 0 to 28
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
1 Year
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy, ambulatory children 1-2 years of age or 18-30 year-old young adults.
Willing to complete the informed consent process.
Availability for follow-up for the planned duration of the study (after last study immunization, approximately 8 weeks for Group A and 4 weeks for Group B).
Acceptable medical history by medical history and vital signs.
Exclusion Criteria:
Group A: Prior vaccination with a seasonal flu vaccine (IIV). Group B: Prior vaccination with the 2012-2013 seasonal flu vaccine (IIV or LAIV).
Prior off-study vaccination with the current 2013-2014 seasonal IIV or LAIV
Allergy to egg or egg products, or to vaccine components.
Life-threatening reactions to previous influenza vaccinations
Active systemic or serious concurrent illness, including febrile illness on 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.
Chronic Hepatitis B or C.
Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible; use of inhaled steroids, or 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 up to 325 mg. per 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
Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
Inactivated vaccine within 14 days prior to study vaccination (inform study staff of any non-study vaccinations received during study period)
Live, attenuated vaccine within 30 days prior to first study vaccination, or planned immunization with a live, attenuated vaccine before completion of study visits (inform study staff of any non-study vaccinations received during study period).
Need for allergy immunizations (that cannot be rescheduled if necessary) during the study period
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
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.
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
Harry Greenberg, 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
First Name & Middle Initial & Last Name & Degree
Xiaosong He, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27655870
Citation
Le Gars M, Kay AW, Bayless NL, Aziz N, Dekker CL, Swan GE, Davis MM, Blish CA. Increased Proinflammatory Responses of Monocytes and Plasmacytoid Dendritic Cells to Influenza A Virus Infection During Pregnancy. J Infect Dis. 2016 Dec 1;214(11):1666-1671. doi: 10.1093/infdis/jiw448. Epub 2016 Sep 21.
Results Reference
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B-cell Immunity to Influenza (SLVP017)- Year 5, 2013
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