Kinetics of the Immune Response to Inactivated Influenza Vaccine in Healthy Adults

NCT03743688 | Completed FDA Drug

• 1 other identifier: 181619
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the body's immune response at different time points to an FDA-approved seasonal influenza vaccine. By better understanding the way the immune system responds to the influenza vaccine, the investigators can design more effective vaccines against influenza.

Conditions

Influenza; Influenza, Human; Vaccine Reaction; Influenza A; Influenza Type B; Influenza A H1N1; Influenza A H3N2

Keywords

Influenza Vaccine; Influenza

Outcome Measures

Primary Outcomes (2)

• Seroconversion (Hemagglutination (HAI) Assay)

  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

• Seroconverstion (Microneutralization (MN) Assay)

  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.

  28 days after vaccination

Study Arms (1)

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.

Biological: Influenza Vaccine Recipients

Interventions

Influenza Vaccine Recipients BIOLOGICAL

0.5 mL intramuscular injection

Also known as: Flucelvax (ccIIV4)

Influenza Vaccine Recipients (ccIIV-4)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Ten (10) individuals 18-45 years of age, 5 males and 5 non-pregnant females, who are in good health by history and meet all eligibility criteria, will be enrolled at one site participating in this study. The target population will reflect the community at large at the participating site.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Human Vaccines Project: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, and peripheral blood mononuclear cells will be collected and stored according to protocol for a variety of immune interrogations.

MeSH Terms

Conditions

Influenza, Human; Orthomyxoviridae Infections

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Buddy Creech, MD, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 16, 2018
• Study Start: December 4, 2018
• Primary Completion: July 26, 2019
• Study Completion: July 26, 2019
• Last Updated: August 5, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)