- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03743688
Kinetics of the Immune Response to Inactivated Influenza Vaccine in Healthy Adults (KIRV)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is an observational study of seasonal, cell-cultured inactivated influenza vaccine (cc-IIV4) in healthy males and non-pregnant females aged 18 to 45 years old, inclusive. This clinical study is designed to comprehensively evaluate the characteristics and kinetics of the immune response to influenza vaccine.
By developing a comprehensive understanding of the mechanisms by which the immune system responds to influenza vaccine, including innate immune system responses, the effect of early influenza exposures, and (eventually) the effect of potent adjuvants, the investigators will be better equipped to design more highly effective vaccines to conquer seasonal influenza and prevent influenza pandemics.
Data from this pilot observational study will guide the design of global studies addressing age-specific responses, the impact of sex and geography, and the role of adjuvants on influenza immunity.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Provide written informed consent prior to initiation of any study procedures.
- Are able to understand and comply with planned study procedures and be available for all study visits.
- Are males or non-pregnant females, 18-45 years of age, inclusive.
- Are in overall good health. (As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical diagnoses that could affect the assessment of the immunogenicity of influenza vaccine.)
- Women of childbearing potential (not sterilized via tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, or successful metal coil placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or <1 year of the last menses if menopausal.) must use an acceptable contraception method (includes, but is not limited to, non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving vaccination, barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices, NuvaRing®, and licensed hormonal methods such as implants, injectables, or oral contraceptives ("the pill")) from 30 days before vaccination until 30 days after vaccination.
- Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to vaccination.
Exclusion Criteria:
- Have an acute illness (an acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site principal investigator or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol) as determined by the site principal investigator or appropriate sub-investigator, within 72 hours prior to vaccination.
- Have any medical disease or condition that, in the opinion of the site principal investigator or appropriate sub-investigator, is a contraindication to study participation.
- Have immunosuppression as a result of an underlying illness or treatment, a recent history or current use of immunosuppressive or immunomodulating disease therapy.
- Use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to vaccination.
- Have known active neoplastic disease or a history of any hematologic malignancy. Non-melanoma, treated, skin cancers are permitted.
- Have known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection.
- Have known hypersensitivity or allergy to components of cell-cultured influenza vaccine.
- Have a history of severe reactions following previous immunization with licensed or unlicensed influenza vaccines.
- Have a history of Guillain-Barre Syndrome.
- Have taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days prior to vaccination.
- Received a licensed live vaccine within 30 days prior to vaccination, or plan to receive a licensed live vaccine within 30 days before or after vaccination.
- Received or plan to receive a licensed, inactivated vaccine within 14 days before or after vaccination.
- Received the 2018-2019 inactivated seasonal influenza vaccine prior to the study.
- Received immunoglobulin or other blood products (with exception of Rho D Ig) within 90 days prior to vaccination.
- Received an experimental agent within 30 days prior to vaccination or expect to receive an experimental agent during the study.
- Are participating or plan to participate in another clinical study with an interventional agent that will be received during the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Influenza Vaccine Recipients (ccIIV-4)
All participants will receive one dose of FDA-approved inactivated influenza vaccine (Flucelvax Quadrivalent) via intramuscular injection (0.5 mL) as part of their standard of care.
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0.5 mL intramuscular injection
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Seroconversion (Hemagglutination (HAI) Assay)
Time Frame: 28 days after vaccination
|
Percentage of subjects achieving seroconversion (defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer ≥1:40 or a pre- vaccination HAI titer ≥1:10 and a minimum four-fold rise in post-vaccination HAI antibody titer) 28 days after vaccination.
|
28 days after vaccination
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Seroconverstion (Microneutralization (MN) Assay)
Time Frame: 28 days after vaccination
|
Percentage of subjects achieving seroconversion (defined as either a pre-vaccination MN titer <1:10 and a post-vaccination MN titer ≥1:40 or a pre-vaccination MN titer ≥1:10 and a minimum four-fold rise in post-vaccination MN titer) 28 days after vaccination.
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28 days after vaccination
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Buddy Creech, MD, MPH, Vanderbilt University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 181619
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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