Early Immune Responses to Inactivated Influenza Vaccine: a Pilot Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kawsar Talaat, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01522248
First received: January 27, 2012
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

Some people experience symptoms just after receiving the seasonal inactivated influenza vaccine. The cause of some of these symptoms is likely to be an immune response to the vaccine. The investigators would like to look at the earliest immune responses to the inactivated influenza vaccine. This pilot study will help us to determine at what time points we should look.


Condition Intervention
Influenza Virus Vaccine
Biological: Trivalent Inactivated Influenza vaccine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Pilot Study to Examine the Early Cytokine Responses After Inactivated Influenza Vaccination in Adults 18-50.

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Timing of cytokine responses to inactivated influenza vaccine [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    This is an exploratory trial to look at the kinetics of early (1st 48 hours) cytokine response to influenza vaccine. Serum collected will be assessed for cytokines, and PBMCs may be assessed for innate and adaptive immune responses, as well as for genetic markers associated with immune responses to vaccination.


Enrollment: 20
Study Start Date: January 2012
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cohort 1
receives vaccine in morning. Blood drawn at 3, 7, 24, and 48 hours and 14 days after vaccination.
Biological: Trivalent Inactivated Influenza vaccine
0.5 ml IM once only
Active Comparator: Cohort 2
receives vaccine in evening, Blood drawn 16, 40 hours and 14 days after vaccination.
Biological: Trivalent Inactivated Influenza vaccine
0.5 ml IM once only

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age between 18-50 years.
  2. Good general health as a result of review of medical history and medications.
  3. Willingness to participate in the study as evidenced by signing informed consent document.
  4. Available for the duration of the trial.

Exclusion Criteria:

  1. Known to be pregnant.
  2. Medical, behavioral, cognitive or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol.
  3. Severe allergy to eggs or any component of the influenza vaccine
  4. Previous receipt of the 2011-2012 season influenza vaccine
  5. Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the subject unable to comply with the protocol.
  6. History of receiving any investigational product within the past 30 days.
  7. Participant has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
  8. History of a severe allergic reaction or anaphylaxis.
  9. Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, or autoimmune thrombocytopenia.
  10. Known immunodeficiency syndrome.
  11. Use of chronic (≥14 days) oral or intravenous corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e. prednisone >10 mg/ day) or immunosuppressive drugs within 30 days of starting this study.
  12. Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to entry into the study.
  13. History of a surgical splenectomy.
  14. Receipt of blood products within the past 6 months.
  15. Refusal to allow storage of samples for future research.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01522248

Locations
United States, Maryland
Johns Hopkins Center for Immunization Research
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
Principal Investigator: Kawsar Talaat, MD Johns Hopkins Bloomberg School of Public Health
  More Information

No publications provided

Responsible Party: Kawsar Talaat, Assistant Scientist, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01522248     History of Changes
Other Study ID Numbers: CIR 281
Study First Received: January 27, 2012
Last Updated: November 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
influenza vaccine
cytokines
chemokines
symptoms

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 23, 2014