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Early Immune Responses to Inactivated Influenza Vaccine: a Pilot Study

Primary Purpose

Influenza Virus Vaccine

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trivalent Inactivated Influenza vaccine
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Influenza Virus Vaccine focused on measuring influenza vaccine, cytokines, chemokines, symptoms

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Johns Hopkins Center for Immunization Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cohort 1

Cohort 2

Arm Description

receives vaccine in morning. Blood drawn at 3, 7, 24, and 48 hours and 14 days after vaccination.

receives vaccine in evening, Blood drawn 16, 40 hours and 14 days after vaccination.

Outcomes

Primary Outcome Measures

Levels of Cytokine Interferon Gamma (IFN-gamma) Responses to Inactivated Influenza Vaccine
This was an exploratory trial to look at the kinetics of early cytokine response to influenza vaccine. Serum collected was 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. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.
Levels of Cytokine Interleukin 8 (IL-8) Cytokine Response to Inactivated Influenza Vaccine
This was an exploratory trial to look at the kinetics of early cytokine response to influenza vaccine. Serum collected was 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. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.
Levels of Cytokine Interferon Induced Gamma Protein (IP-10) Responses to Inactivated Influenza Vaccine
This was an exploratory trial to look at the kinetics of early (1st 48 hours) cytokine response to influenza vaccine. Serum collected was 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. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.

Secondary Outcome Measures

Full Information

First Posted
January 27, 2012
Last Updated
March 14, 2019
Sponsor
Johns Hopkins Bloomberg School of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT01522248
Brief Title
Early Immune Responses to Inactivated Influenza Vaccine: a Pilot Study
Official Title
A Pilot Study to Examine the Early Cytokine Responses After Inactivated Influenza Vaccination in Adults 18-50.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Virus Vaccine
Keywords
influenza vaccine, cytokines, chemokines, symptoms

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Active Comparator
Arm Description
receives vaccine in morning. Blood drawn at 3, 7, 24, and 48 hours and 14 days after vaccination.
Arm Title
Cohort 2
Arm Type
Active Comparator
Arm Description
receives vaccine in evening, Blood drawn 16, 40 hours and 14 days after vaccination.
Intervention Type
Biological
Intervention Name(s)
Trivalent Inactivated Influenza vaccine
Intervention Description
0.5 ml IM once only
Primary Outcome Measure Information:
Title
Levels of Cytokine Interferon Gamma (IFN-gamma) Responses to Inactivated Influenza Vaccine
Description
This was an exploratory trial to look at the kinetics of early cytokine response to influenza vaccine. Serum collected was 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. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.
Time Frame
0 hours, 16 hours, 24 hours, 14 days
Title
Levels of Cytokine Interleukin 8 (IL-8) Cytokine Response to Inactivated Influenza Vaccine
Description
This was an exploratory trial to look at the kinetics of early cytokine response to influenza vaccine. Serum collected was 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. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.
Time Frame
0 hours, 16 hours, 24 hours, 14 days
Title
Levels of Cytokine Interferon Induced Gamma Protein (IP-10) Responses to Inactivated Influenza Vaccine
Description
This was an exploratory trial to look at the kinetics of early (1st 48 hours) cytokine response to influenza vaccine. Serum collected was 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. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.
Time Frame
0 hours, 16 hours, 24 hours, 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age between 18-50 years. Good general health as a result of review of medical history and medications. Willingness to participate in the study as evidenced by signing informed consent document. Available for the duration of the trial. Exclusion Criteria: Known to be pregnant. 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. Severe allergy to eggs or any component of the influenza vaccine Previous receipt of the 2011-2012 season influenza vaccine 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. History of receiving any investigational product within the past 30 days. Participant has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months. History of a severe allergic reaction or anaphylaxis. 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. Known immunodeficiency syndrome. 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. Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to entry into the study. History of a surgical splenectomy. Receipt of blood products within the past 6 months. Refusal to allow storage of samples for future research.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kawsar Talaat, MD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Center for Immunization Research
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28991404
Citation
Talaat KR, Halsey NA, Cox AB, Coles CL, Durbin AP, Ramakrishnan A, Bream JH. Rapid changes in serum cytokines and chemokines in response to inactivated influenza vaccination. Influenza Other Respir Viruses. 2018 Mar;12(2):202-210. doi: 10.1111/irv.12509. Epub 2018 Jan 4.
Results Reference
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Early Immune Responses to Inactivated Influenza Vaccine: a Pilot Study

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