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New treatment option for Vaccine Response
Official title Durability of Vaccine Responses
ClinicalTrials.gov ID: NCT05801978
What this study is testing
What is Live Attenuated Yellow Fever 17D Vaccine?
Live Attenuated Yellow Fever 17D Vaccine is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for vaccine response.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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...
- Insulin dependent diabetes
- Severe heart disease (including arrhythmias)
See the full eligibility 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...
- 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...
- 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...
- Insulin dependent diabetes
- Severe heart disease (including arrhythmias)
- Severe lung disease
- Severe liver disease
- Severe kidney disease
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Decatur, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Decatur, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.