Pilot Study in Young Adults to Examine the Kinetics of Changes in the B-cell Repertoire Following TIV Immunization

Influenza Clinical Trial

— SLVP023  

Official title:

Pilot Study in Young Adults to Examine the Kinetics of Changes in the B-cell Repertoire Following TIV Immunization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02987374
• Other study ID #: SU-24167
• Secondary ID: U19AI057229-06
• Status: Completed
• Phase: Phase 4
• First received: December 6, 2016
• Last updated: December 7, 2016
• Start date: May 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose is to investigate B-cell response to the trivalent Influenza Vaccine (TIV) in healthy young adults. In particular, we will use unique strategies to study in detail the immune responses of immunoglobulins and antibody CDR3 before and after immunization.

Description:

This is an exploratory study using a strategy that has not been previously employed to investigate B-cell responses. We will collect blood samples from the volunteers at a higher frequency than in the two previous flu seasons to better define the dynamic response to vaccination. The objective is to compare the Ig gene repertoire before and after vaccination by deep sequencing PBMC and proteomic analysis of antibody CDR3 regions at 10 different time points before and after immunization.

This is a Phase IV study of healthy adults who are given standard TIV off-season. There are no exclusions for gender, ethnicity or race. Following confirmation of written informed consent, baseline blood samples will be drawn from all study participants at Day -5, Day -3 and Day 0 prior to immunization, and at Days 1, 4, 7, 9, 11, 28 and 180 post-immunization. Volunteers will be vaccine-naïve for the 2010-2011 and 2011-2012 seasonal influenza vaccines. All participants will receive a single dose of the current seasonal influenza vaccine by intramuscular (IM) injection at Day 0.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

1. Otherwise healthy, 18-30 year old young adult.

2. Availability for follow-up for the planned duration of the study at least 180 days after immunization.

3. Acceptable medical history by medical history and vital signs.

Exclusion Criteria:

1. Prior vaccination with 2010-2011 seasonal TIV or LAIV.

2. Prior off-study vaccination with the current 2011-2012 seasonal TIV or LAIV

3. Weight less than 110 pounds.

4. Allergy to egg or egg products, or to vaccine components, including gelatin or thimerosal (thimerosal in TIV multidose vials only).

5. Life-threatening reactions to previous influenza vaccinations

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

7. History of immunodeficiency (including HIV infection)

8. 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.

9. Blood pressure >150 systolic or >95 diastolic at first study visit

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

11. Chronic Hepatitis B or C.

12. Recent or current use of immunosuppressive medication, including systemic glucocorticoids. Corticosteroid nasal sprays and topical steroids are permissible.

13. 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).

14. 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.

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

16. 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.

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

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

19. Receipt of inactivated vaccine 14 days prior to study enrollment, planned vaccinations prior to completion of Visit 09 (Day 28 after study vaccination), or planned vaccination 14 days prior to Visit 10 (6 months after study vaccination).

20. Receipt of live, attenuated vaccine 60 days prior to study enrollment, planned vaccination prior to completion of Visit 09 (Day 28 after study vaccination), or planned vaccination 14 days prior to Visit 10 (6 months after study vaccination).

21. History of Guillain-Barré Syndrome

22. Pregnant or lactating woman

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

24. Donation of the equivalent of a unit of blood within 6 weeks prior to study enrollment, or during the first 5 weeks of study participation.

25. A member of the study team or their family member, to include investigators, research laboratory staff, clinical research staff.

26. 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Influenza

Intervention

Biological:
• 2011-2012 Fluzone IIV3
This vaccine is given intramuscularly (IM)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Allergy and Infectious Diseases (NIAID)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Ig gene and protein expression of antibody CDR3 regions from pre- to post-immunization		Day -5 to 180 post-immunization	No