Early Immune Responses to Inactivated Influenza Vaccine: a Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01522248
Recruitment Status : Completed
First Posted : January 31, 2012
Last Update Posted : September 18, 2015
Information provided by (Responsible Party):
Kawsar Talaat, Johns Hopkins University

Brief Summary:
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 or disease Intervention/treatment Phase
Influenza Virus Vaccine Biological: Trivalent Inactivated Influenza vaccine Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : January 2012
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Timing of cytokine responses to inactivated influenza vaccine [ Time Frame: 48 hours ]
    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.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01522248

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

Responsible Party: Kawsar Talaat, Assistant Scientist, Johns Hopkins University Identifier: NCT01522248     History of Changes
Other Study ID Numbers: CIR 281
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: September 18, 2015
Last Verified: September 2015

Keywords provided by Kawsar Talaat, Johns Hopkins University:
influenza vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs