The Human Mucosal Immune Responses to Influenza Virus (SLVP026)
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|ClinicalTrials.gov Identifier: NCT03023553|
Recruitment Status : Completed
First Posted : January 18, 2017
Results First Posted : March 9, 2017
Last Update Posted : April 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: Fluzone® Biological: FluMist®||Phase 4|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|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 Start Date :||December 2012|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.
Influenza Virus Vaccine Suspension for Intramuscular Injection
Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.
Influenza Virus Vaccine Live, Intranasal Spray
- Number of Participants From Each Arm Who Received Influenza Vaccine [ Time Frame: Day 0 to 28 ]
- Number of Participants With Related Adverse Events [ Time Frame: Day 0 to 28 post-immunization ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023553
|Principal Investigator:||Cornelia Dekker, MD||Stanford University|
|Principal Investigator:||Harry Greenberg, MD||Stanford University|
|Principal Investigator:||Xiaosong He, PhD||Stanford Universityh|