The Effects of Attenuated Versus Inactivated Flu Vaccine in Twin Sets
Overview
- Phase
- Phase 1
- Intervention
- Live attenuated influenza vaccine (LAIV4)
- Conditions
- Influenza
- Sponsor
- Stanford University
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- HAI Titers
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is one project of a larger ongoing study related to the immune system's response to the flu virus. This study is designed to investigate the immune response to the live attenuated influenza vaccine (LAIV) vs. the Inactivated Influenza Vaccine (IIV) in identical and fraternal twins.
Detailed Description
This is a Phase I mechanistic study of licensed influenza vaccines. The study requires 10 monozygotic and 10 dizygotic sets of twins (40 total participants) to enroll. The duration of the study for an individual volunteer will be 4 weeks including screening and active participation. The study has a total of 3 visits. First visit: Procedures during this visit are: Informed consent process, enrollment, study assessments, 20 ml blood draw, and vaccination. Participants will be randomized to receive either LAIV or IIV. The time required to complete the first study visit will be about 30-40 minutes. 2nd (day 7 post vaccination) and 3rd (day 28 post vaccination ) visit: 20 ml blood will be obtained and the visit will take approximately 15 minutes.
Investigators
Philip Grant
Assistant Professor of Medicine (Infectious Diseases)
Stanford University
Eligibility Criteria
Inclusion Criteria
- •2-20 year old male and female patients
- •Willing and able to complete the informed consent process
- •Availability of twin pair also agreeable and eligible for study inclusion
- •Availability for follow-up for the planned duration of the study
- •Acceptable medical history by review of inclusion/exclusion criteria
Exclusion Criteria
- •Prior off-study vaccination with seasonal influenza vaccine within three months of study vaccination
- •Life-threatening reactions to previous influenza vaccinations
- •Asthma (contraindication for receipt of LAIV4)
- •Allergy to egg or egg products or to vaccine components including gentamicin, gelatin, arginine or MSG.
- •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; may include significant liver disease, diabetes mellitus treated with insulin or moderate to severe renal disease
- •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 and topical steroids are permissible). Use of oral steroids (\<20mg prednisone-equivalent/day) may be acceptable after review by the investigator.
Arms & Interventions
MZ twins (IIV or LAIV4)
Up to 20 healthy monozygotic (MZ) individual twin volunteers, 2-20 years old, will be randomized within the twin pair to receive either inactivated influenza vaccine quadrivalent (IIV4) Fluzone® Quadrivalent vaccine or live, attenuated influenza vaccine quadrivalent (LAIV4) FluMist® Quadrivalent. Each volunteer will complete a total of 3 visits: Day 0 (pre-immunization), Day 7 and Day 28 post-immunization. All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs).
Intervention: Live attenuated influenza vaccine (LAIV4)
MZ twins (IIV or LAIV4)
Up to 20 healthy monozygotic (MZ) individual twin volunteers, 2-20 years old, will be randomized within the twin pair to receive either inactivated influenza vaccine quadrivalent (IIV4) Fluzone® Quadrivalent vaccine or live, attenuated influenza vaccine quadrivalent (LAIV4) FluMist® Quadrivalent. Each volunteer will complete a total of 3 visits: Day 0 (pre-immunization), Day 7 and Day 28 post-immunization. All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs).
Intervention: Inactivated Influenza Vaccine (IIV4)
DZ twins (IIV or LAIV4)
Up to 20 healthy dizygotic (DZ) individual twin volunteers, 2-20 years old, will be randomized within the twin pair to receive either inactivated influenza vaccine quadrivalent (IIV4) Fluzone® Quadrivalent vaccine or live, attenuated influenza vaccine quadrivalent (LAIV4) FluMist® Quadrivalent. Each volunteer will complete a total of 3 visits: Day 0 (pre-immunization), Day 7 and Day 28 post-immunization. All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs).
Intervention: Live attenuated influenza vaccine (LAIV4)
DZ twins (IIV or LAIV4)
Up to 20 healthy dizygotic (DZ) individual twin volunteers, 2-20 years old, will be randomized within the twin pair to receive either inactivated influenza vaccine quadrivalent (IIV4) Fluzone® Quadrivalent vaccine or live, attenuated influenza vaccine quadrivalent (LAIV4) FluMist® Quadrivalent. Each volunteer will complete a total of 3 visits: Day 0 (pre-immunization), Day 7 and Day 28 post-immunization. All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs).
Intervention: Inactivated Influenza Vaccine (IIV4)
Outcomes
Primary Outcomes
HAI Titers
Time Frame: Day 28
Evaluate HAI titers in response to influenza vaccination. An HAI titer is a hemoglobin assay that correlates to protection from influenza infection; an HAI titer of 40 or greater is considered to be protective.