RECRUITING

Revealing Protective Immunity to Influenza Using Systems Immunology

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goals of this study are to better understand the human immune response to influenza vaccines, specifically the live attenuated (weakened) influenza vaccine given as a nasal spray. Better understanding why this vaccine does not work as well in adults as it does in children may help design better influenza vaccines.

Official Title

Revealing Protective Immunity to Influenza Using Systems Immunology

Quick Facts

Study Start:2024-10-14

Study Completion:2027-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06501963

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 49 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Able to understand and give informed consent * Participants of child bearing potential must agree to use effective birth control for the duration of the study. A negative urine pregnancy test must be documented prior to vaccination.	* History of allergy or serious adverse reaction, including Guillain-Barré syndrome, to a vaccine or vaccine products * History of a medical condition resulting in impaired immunity such as active solid tumors, leukemia, lymphoma, chemotherapy or radiation therapy, autoimmune conditions, or splenic dysfunction. Persons with previous skin cancers or cured non-lymphatic tumors are not excluded from the study. * History of asthma, cochlear implant, or active cerebrospinal fluid leak * Use of immune modifying drugs including: systemic steroids for more than 1 week (such as prednisone \> 20mg/day), chronic administration (more than 14 days total) of immunosuppressive or immunomodulatory drugs in the prior 3 months * History of HIV, Hepatitis B or Hepatitis C infection * Chronic clinically significant medical problems that could be considered active or unstable (i.e diagnosed within the past 3 months or requiring a change in medication within the past 3 months). This is including (but not limited to): * Insulin dependent diabetes * Severe heart disease (including arrhythmias) * Severe lung disease * Severe liver disease * Severe kidney disease * Severe hypertension: defined as life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit). * Congenital genetic syndromes (e.g., trisomy 21) * Body Mass Index (BMI) \> 35 * Pregnancy or breast feeding, or plans to become pregnant in the next month * History of influenza infection or vaccination within the current or previous influenza season * Receipt of blood products or immune globulin product within the prior 3 months * History of excessive alcohol consumption, drug use, psychiatric conditions, social conditions or occupational conditions that in the opinion of the investigator would preclude compliance with the trial * Receipt of any live vaccines 30 days before, or plans to receive any live vaccines 30 days after vaccination * Receipt of any inactivated vaccines 14 days before, or plans to receive any inactivated vaccines 14 days after vaccination * Receipt of any non-registered or other investigational product in 30 days before, or plans to receive any other investigational product 30 days after vaccination * Temporary

Inclusion Criteria

Exclusion Criteria

* Able to understand and give informed consent
* Participants of child bearing potential must agree to use effective birth control for the duration of the study. A negative urine pregnancy test must be documented prior to vaccination.

* History of allergy or serious adverse reaction, including Guillain-Barré syndrome, to a vaccine or vaccine products
* History of a medical condition resulting in impaired immunity such as active solid tumors, leukemia, lymphoma, chemotherapy or radiation therapy, autoimmune conditions, or splenic dysfunction. Persons with previous skin cancers or cured non-lymphatic tumors are not excluded from the study.
* History of asthma, cochlear implant, or active cerebrospinal fluid leak
* Use of immune modifying drugs including: systemic steroids for more than 1 week (such as prednisone \> 20mg/day), chronic administration (more than 14 days total) of immunosuppressive or immunomodulatory drugs in the prior 3 months
* History of HIV, Hepatitis B or Hepatitis C infection
* Chronic clinically significant medical problems that could be considered active or unstable (i.e diagnosed within the past 3 months or requiring a change in medication within the past 3 months). This is including (but not limited to):
* Insulin dependent diabetes
* Severe heart disease (including arrhythmias)
* Severe lung disease
* Severe liver disease
* Severe kidney disease
* Severe hypertension: defined as life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit).
* Congenital genetic syndromes (e.g., trisomy 21)
* Body Mass Index (BMI) \> 35
* Pregnancy or breast feeding, or plans to become pregnant in the next month
* History of influenza infection or vaccination within the current or previous influenza season
* Receipt of blood products or immune globulin product within the prior 3 months
* History of excessive alcohol consumption, drug use, psychiatric conditions, social conditions or occupational conditions that in the opinion of the investigator would preclude compliance with the trial
* Receipt of any live vaccines 30 days before, or plans to receive any live vaccines 30 days after vaccination
* Receipt of any inactivated vaccines 14 days before, or plans to receive any inactivated vaccines 14 days after vaccination
* Receipt of any non-registered or other investigational product in 30 days before, or plans to receive any other investigational product 30 days after vaccination
* Temporary

Contacts and Locations

Study Contact

Daniel Graciaa, MD, MPH, MSc

CONTACT

404-712-1370

dsgraci@emory.edu

Daniel Graciaa, MD, MPH, MSc

CONTACT

404-712-9018

Principal Investigator

Daniel Graciaa, MD, MPH, MSc

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

Hope Clinic of the Emory Vaccine Center

Decatur, Georgia, 30030

United States

Collaborators and Investigators

Sponsor: Emory University

Daniel Graciaa, MD, MPH, MSc, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-14

Study Completion Date2027-02-28

Study Record Updates

Study Start Date2024-10-14

Study Completion Date2027-02-28

Terms related to this study

Keywords Provided by Researchers

Vaccination

Additional Relevant MeSH Terms

Influenza