The Human Mucosal Immune Responses to Influenza Virus (SLVP026)
Primary Purpose
Influenza
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Fluzone®
FluMist®
Sponsored by
About this trial
This is an interventional basic science trial for Influenza focused on measuring Trivalent, inactivated influenza vaccine, Live, attenuated influenza vaccine, Nasopharyngeal swabs, Young adults
Eligibility Criteria
Inclusion Criteria:
- Otherwise healthy, ambulatory adult between the ages of 18-30 years
- Willing to complete the informed consent process.
- Availability for follow-up at Day 2 (LAIV Group only)
- Acceptable medical history by review of inclusion/exclusion criteria and vital signs.
Exclusion Criteria:
- Prior off-study vaccination with the current 2012-2013 seasonal TIV or LAIV
- Allergy to egg or egg products, or to vaccine components, including thimerosal (TIV multidose vials only), or gentamicin, gelatin, arginine or MSG (for LAIV only).
- Life-threatening reactions to previous influenza vaccinations
- Asthma or history of wheezing (except for controls in the study who will be assigned to receive TIV).
- 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.
- Blood pressure >150 systolic or >95 diastolic at first study visit
- Hospitalization in the past year for congestive heart failure or emphysema.
- Chronic Hepatitis B or C.
- Recent or current use of immunosuppressive medication, including systemic glucocorticoids. Corticosteroid nasal sprays for allergies and topical steroids are permissible. Inhaled steroids for conditions such as asthma are not permissible for volunteers in the LAIV group.
- Participants in close contact with anyone who has a severely weakened immune system should not receive LAIV (LAIV Group only).
- 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. aspirin 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 of planned used during the study.
- Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
- Inactivated vaccine 14 days prior to vaccination or planned non-study vaccination prior to completion of the last study visit.
- Live, attenuated vaccine within 60 days of vaccination or planned non-study vaccination prior to completion of the last study visit.
- History of Guillain-Barré 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 donation prior to completion of the last visit.
- 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
TIV Group
LAIV Group
Arm Description
Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.
Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.
Outcomes
Primary Outcome Measures
Number of Participants From Each Arm Who Received Influenza Vaccine
Secondary Outcome Measures
Number of Participants With Related Adverse Events
Full Information
NCT ID
NCT03023553
First Posted
January 13, 2017
Last Updated
March 27, 2017
Sponsor
Stanford University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT03023553
Brief Title
The Human Mucosal Immune Responses to Influenza Virus (SLVP026)
Official Title
The Human Mucosal Immune Responses to Influenza Virus: A Systems Biology Approach. Innate Immune Responses to Influenza Virus in Single Human Nasal Epithelial Cells
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 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 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).
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, Live, attenuated influenza vaccine, Nasopharyngeal swabs, 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
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TIV Group
Arm Type
Other
Arm Description
Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.
Arm Title
LAIV Group
Arm Type
Other
Arm Description
Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.
Intervention Type
Biological
Intervention Name(s)
Fluzone®
Intervention Description
Influenza Virus Vaccine Suspension for Intramuscular Injection
Intervention Type
Biological
Intervention Name(s)
FluMist®
Intervention Description
Influenza Virus Vaccine Live, Intranasal Spray
Primary Outcome Measure Information:
Title
Number of Participants From Each Arm 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
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Otherwise healthy, ambulatory adult between the ages of 18-30 years
Willing to complete the informed consent process.
Availability for follow-up at Day 2 (LAIV Group only)
Acceptable medical history by review of inclusion/exclusion criteria and vital signs.
Exclusion Criteria:
Prior off-study vaccination with the current 2012-2013 seasonal TIV or LAIV
Allergy to egg or egg products, or to vaccine components, including thimerosal (TIV multidose vials only), or gentamicin, gelatin, arginine or MSG (for LAIV only).
Life-threatening reactions to previous influenza vaccinations
Asthma or history of wheezing (except for controls in the study who will be assigned to receive TIV).
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.
Blood pressure >150 systolic or >95 diastolic at first study visit
Hospitalization in the past year for congestive heart failure or emphysema.
Chronic Hepatitis B or C.
Recent or current use of immunosuppressive medication, including systemic glucocorticoids. Corticosteroid nasal sprays for allergies and topical steroids are permissible. Inhaled steroids for conditions such as asthma are not permissible for volunteers in the LAIV group.
Participants in close contact with anyone who has a severely weakened immune system should not receive LAIV (LAIV Group only).
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. aspirin 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 of planned used during the study.
Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
Inactivated vaccine 14 days prior to vaccination or planned non-study vaccination prior to completion of the last study visit.
Live, attenuated vaccine within 60 days of vaccination or planned non-study vaccination prior to completion of the last study visit.
History of Guillain-Barré 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 donation prior to completion of the last visit.
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
Xiaosong He, PhD
Organizational Affiliation
Stanford Universityh
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The NIH Human Immunology Project Consortium (HIPC) data repositories (ImmPORT) may store the results of the research assays results. Genetic data that is developed in this study may be made available to other researchers through the National Center for Biotechnology Information (NCBI) databases. Results from research assays will be labeled with a unique identification code and the volunteer identity (except for age) will not be disclosed.
Learn more about this trial
The Human Mucosal Immune Responses to Influenza Virus (SLVP026)
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