Durability of Vaccine Responses

Launched by EMORY UNIVERSITY · Mar 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how well different vaccines, specifically the yellow fever vaccine and the quadrivalent influenza vaccine, create long-lasting protection against infections. Researchers want to understand why some vaccines provide strong immunity for many years while others, like the flu vaccine, offer shorter protection. To do this, willing participants will receive one of these vaccines, and researchers will collect blood samples to see how their immune systems respond over time.

To be eligible for this study, participants should be between 18 and 50 years old and able to understand the study details and provide consent. There are some health conditions and past medical histories that may disqualify someone from participating, such as having serious allergies to vaccines or certain immune system disorders. Participants will be asked to avoid live vaccines for a period before and after the study vaccines, and women who can become pregnant will need to use effective birth control for the first three months. Overall, participants can expect to contribute to important research that could help improve our understanding of vaccine effectiveness and how long their protections last.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Able to understand and give informed consent.
• • Age 18-50 years.
• • Participants agree not to take any live vaccines 30 days before or after (14 days for inactivated) vaccination.
• • 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.
• Exclusion Criteria:
• • 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 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.
• • History of Hepatitis B or Hepatitis C infection.
• * 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):
• • 1. Insulin dependent diabetes
• • 2. Severe heart disease (including arrhythmias)
• • 3. Severe lung disease
• • 4. Severe liver disease
• • 5. Severe kidney disease
• • 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))
• • Thymus gland problems (such as myasthenia gravis, DiGeorge syndrome, thymoma) or removal of thymus gland or history of uncontrolled autoimmune disorder.
• • Pregnancy or breast feeding, or plans to become pregnant in the first 3 months of study participation.
• • Receipt of blood products or immune globulin product within the prior 3 months.
• • Active duty military.
• • 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.
• • Additional Exclusion Criteria for YF-17D Arm
• • History of previous yellow fever, West Nile, Dengue, St. Louis encephalitis, or Japanese encephalitis vaccination or infection.
• • Previous residence in a country where there is a risk of yellow fever virus (YFV) transmission
• • History of allergy to eggs, chicken, or gelatin.
• • Additional Exclusion Criteria for QIV Arm
• • History of influenza infection within the same influenza season.