The Effects of Attenuated Versus Inactivated Flu Vaccine in Twin Sets

Not Recruiting

Trial ID: NCT03898986


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.

Official Title

The Effects of Attenuated Versus Inactivated Flu Vaccine in Twin Sets

Stanford Investigator(s)

Philip Grant
Philip Grant

Clinical Associate Professor, Medicine - Infectious Diseases


Inclusion Criteria:

   1. 2-20 year old male and female patients

   2. Willing and able to complete the informed consent process

   3. Availability of twin pair also agreeable and eligible for study inclusion

   4. Availability for follow-up for the planned duration of the study

   5. Acceptable medical history by review of inclusion/exclusion criteria

Exclusion Criteria:

   1. Prior off-study vaccination with seasonal influenza vaccine within three months of
   study vaccination

   2. Life-threatening reactions to previous influenza vaccinations

   3. Asthma (contraindication for receipt of LAIV4)

   4. Allergy to egg or egg products or to vaccine components including gentamicin, gelatin,
   arginine or MSG.

   5. Active systemic or serious concurrent illness, including febrile illness on the day of

   6. History of immunodeficiency (including HIV infection)

   7. Known or suspected impairment of immunologic function; may include significant liver
   disease, diabetes mellitus treated with insulin or moderate to severe renal disease

   8. Hospitalization in the past year for congestive heart failure or emphysema.

   9. Chronic Hepatitis B or C.

10. 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.

11. Participants in close contact with anyone who has a severely weakened immune system

12. 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).

13. 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.

14. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular
   medical follow up or hospitalization during the preceding year

15. 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 will be
   reviewed by investigators to determine if study participation would affect the
   volunteer's safety or compliance with the protocol.

16. Has taken an influenza antiviral medication within 48 hours prior to study vaccination
   [If yes, may not eligible if unable to schedule at an appropriate interval].

17. Receipt of blood or blood products within the past 6 months or planned used during the

18. Medical or psychiatric condition or occupational responsibilities that preclude
   participant compliance with the protocol

19. Receipt of an inactivated vaccine 14 days prior to study enrollment, or planned
   vaccinations prior to completion of last study visit (~ 14 days after study

20. Receipt of a live, attenuated vaccine within 60 days prior to enrollment of planned
   vaccination prior to completion of last study visit (~ 14 days after study enrollment)

21. Need for allergy immunization (that cannot be postponed) until after the last study

22. History of Guillain-Barre# syndrome

23. Pregnant woman

24. Breastfeeding woman

25. Use of investigational agents within 30 days prior to enrollment or planned use during
   the study.

26. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or
   donation of platelets within 2 weeks of enrollment or planned donation prior to
   completion of the last visit.

27. 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.


biological: Live attenuated influenza vaccine (LAIV4)

biological: Inactivated Influenza Vaccine (IIV4)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Philip M Grant, MD