NCT01522248

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2012

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
7.1 years until next milestone

Results Posted

Study results publicly available

March 15, 2019

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

1 month

First QC Date

January 27, 2012

Results QC Date

August 22, 2018

Last Update Submit

March 14, 2019

Conditions

Influenza Virus Vaccine

Keywords

influenza vaccinecytokineschemokinessymptoms

Outcome Measures

Primary Outcomes (3)

  • 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.

    0 hours, 16 hours, 24 hours, 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.

    0 hours, 16 hours, 24 hours, 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.

    0 hours, 16 hours, 24 hours, 14 days

Study Arms (2)

Cohort 1

ACTIVE COMPARATOR

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

Biological: Trivalent Inactivated Influenza vaccine

Cohort 2

ACTIVE COMPARATOR

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

Biological: Trivalent Inactivated Influenza vaccine

Interventions

Trivalent Inactivated Influenza vaccineBIOLOGICAL

0.5 ml IM once only

Cohort 1Cohort 2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Center for Immunization Research

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

  • 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.

    PMID: 28991404RESULT

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Kawsar Talaat
Organization
Johns Hopkins University
ktalaat@jhu.edu
410-502-9627

Study Officials

  • Kawsar Talaat, MD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2012

First Posted

January 31, 2012

Study Start

January 1, 2012

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

March 15, 2019

Results First Posted

March 15, 2019

Record last verified: 2019-03

Locations

US(1)