RECRUITING

Systems Biological Assessment of the Durability of Vaccine Responses

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Vaccine ResponseDurabilityImmune Response

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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 ability of the vaccines today to generate a long-lasting protection against infections varies greatly from one vaccine to another. The yellow fever vaccine (YF-17D) is one of the most successful vaccines ever developed, having been administered to over 600 million people globally. A single vaccination is known to induce durable protection over several decades. In contrast, the quadrivalent influenza vaccine (QIV) generates an immunity that wanes quickly with no long-lasting protection. Currently, the duration of immune protection for new vaccines is difficult to predict during vaccine product development and can only be ascertained by a "wait and see" approach. This is due, in part, to the fact that some of the signals that activate a durable immune system protection remain unknown. This study aims to provide a better understanding of this problem by vaccinating willing participants with either the FDA-approved yellow fever vaccine or the quadrivalent influenza vaccine and collecting baseline and follow-up biologic samples to compare how the immune system reacts.

Official Title

Systems Biological Assessment of the Durability of Vaccine Responses

Quick Facts

Study Start:2023-04-11
Study Completion:2025-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05801978

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 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to understand and give informed consent.
  2. * Age 18-50 years.
  3. * Participants agree not to take any live vaccines 30 days before or after (14 days for inactivated) vaccination.
  4. * Women of child bearing potential must agree to use effective birth control for the first 3 months of the study. A negative urine pregnancy test must be documented prior to vaccination and prior to tissue sampling procedures.
  1. * History of allergy or serious adverse reaction, including Guillain-Barré syndrome, to a vaccine or vaccine products.
  2. * History of a medical condition resulting in impaired immunity (such as HIV infection, cancer, particularly leukemia, lymphoma, use of immunosuppressive or antineoplastic drugs or X-ray treatment). Persons with previous skin cancers or cured non-lymphatic tumors are not excluded from the study.
  3. * History of Hepatitis B or Hepatitis C infection.
  4. * Chronic clinically significant medical problems that could affect the immune response, require medication that would affect the immune response, or have signs or symptoms that could be confused with reactions to vaccination, including (but not limited to):
  5. 1. Insulin dependent diabetes
  6. 2. Severe heart disease (including arrhythmias)
  7. 3. Severe lung disease
  8. 4. Severe liver disease
  9. 5. Severe kidney disease
  10. 6. Grade 4 hypertension (\*Grade 4 hypertension per CTCAE criteria is defined as life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit))
  11. * Thymus gland problems (such as myasthenia gravis, DiGeorge syndrome, thymoma) or removal of thymus gland or history of uncontrolled autoimmune disorder.
  12. * Pregnancy or breast feeding, or plans to become pregnant in the first 3 months of study participation.
  13. * Receipt of blood products or immune globulin product within the prior 3 months.
  14. * Active duty military.
  15. * 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.
  16. * History of previous yellow fever, West Nile, Dengue, St. Louis encephalitis, or Japanese encephalitis vaccination or infection.
  17. * Previous residence in a country where there is a risk of yellow fever virus (YFV) transmission
  18. * History of allergy to eggs, chicken, or gelatin.
  19. * History of influenza infection within the same influenza season.

Contacts and Locations

Study Contact

Nadine Rouphael, MD
CONTACT
404-712-1435
nroupha@emory.edu

Principal Investigator

Nadine Rouphael, MD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Emory University Hospital
Atlanta, Georgia, 30322
United States
Emory Winship Cancer Institute
Atlanta, Georgia, 30322
United States
The Hope Clinic of Emory University
Decatur, Georgia, 30030
United States

Collaborators and Investigators

Sponsor: Emory University

  • Nadine Rouphael, MD, 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 Date2023-04-11
Study Completion Date2025-09-30

Study Record Updates

Study Start Date2023-04-11
Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

  • Durability
  • Immune Response

Additional Relevant MeSH Terms

  • Vaccine Response