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New treatment option for Yellow Fever
Official title Immunogenicity of Yellow Fever Vaccine 17D in Adults With Prior 17D Vaccination
ClinicalTrials.gov ID: NCT05859490
What this study is testing
What is 17D?
17D is an investigational medicine, given as an once-daily, being studied as a potential treatment for yellow fever.
Also referred to as YFVax.
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 goal of this clinical trial is to assess the immune response to the yellow fever vaccine 17D in adults with prior 17D vaccination. The main questions this study aims to answer are: how does prior vaccination affect antibody responses to re-vaccination?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 49. Healthy volunteers may be eligible.
You may be able to join if
- Aged ≥20 to \<50 years.
- Male or female.
- In good health at the time of screening as determined by medical history, physical examination, and clinical judgement of the investigator.
- Documented history of Yellow fever vaccination 8 or more years prior. Documentation must be on a primary (not copied) vaccination card or a fully...
- people who can comply with all trial procedures and are available for the duration of follow-up.
You likely can't join if
- A clinically active infection or self-reported body temperature ≥38°C (100.4°F) within 3 days of scheduled date of vaccination (consider whether the...
- A known hypersensitivity or allergy to any of the trial vaccine components including eggs.
- Behavioral/cognitive impairment that, in the investigator's opinion, may interfere with the subject's ability to participate safely in the trial.
- Any history of neurologic disorder, seizure disorder or neuro-inflammatory disease.
- Any illness, or history of any illness that, in the investigator's opinion, could interfere with the trial or pose an additional risk to the subject...
- Known or suspected impairment/alteration of immune function, including:
See the full eligibility criteria
- Aged ≥20 to \<50 years.
- Male or female.
- In good health at the time of screening as determined by medical history, physical examination, and clinical judgement of the investigator.
- Documented history of Yellow fever vaccination 8 or more years prior. Documentation must be on a primary (not copied) vaccination card or a fully completed electronic medical record entry including date of...
- people who can comply with all trial procedures and are available for the duration of follow-up.
- A clinically active infection or self-reported body temperature ≥38°C (100.4°F) within 3 days of scheduled date of vaccination (consider whether the finding is an exclusion criterion or criterion for delay of...
- A known hypersensitivity or allergy to any of the trial vaccine components including eggs.
- Behavioral/cognitive impairment that, in the investigator's opinion, may interfere with the subject's ability to participate safely in the trial.
- Any history of neurologic disorder, seizure disorder or neuro-inflammatory disease.
- Any illness, or history of any illness that, in the investigator's opinion, could interfere with the trial or pose an additional risk to the subject during the trial period.
- Known or suspected impairment/alteration of immune function, including:
- Chronic use of oral steroids within 60 days prior to enrollment. Inhaled steroids are allowed.
- Receipt of parenteral steroids within 60 days prior to screening visit.
- Receipt of immunoglobulins and/or any blood products within the 3 months prior to enrollment or planned receipt during the trial.
- Receipt of immunostimulants within 60 days prior to screening visit
- Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months of enrollment.
- Known Human Immunodeficiency Virus (HIV) infection or HIV-related disease.
- Hepatitis C virus infection.
- Genetic immunodeficiency.
- History of splenic or thymic dysfunction.
- Any serious chronic or progressive disease as assessed by the investigator (eg, neoplasm, hematologic malignancies, insulin dependent diabetes; cardiac, renal, or hepatic disease).
- Body Mass Index (BMI) greater than or equal to 35 kg/m2.
- Concurrent participation in any clinical trial with another investigational product 30 days prior to or during the conduct of this trial.
- Vaccination within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment or plans to receive any vaccine within 28 days of trial vaccine administration (consider whether applicable as an...
- Use of antipyretics and/or analgesic medications within 24 hours prior to vaccination. Trial entry should be delayed to allow for a full 24-hours to have passed since last use of antipyretics and/or analgesic...
- people with history of substance or alcohol abuse within the past 2 years.
- people who are pregnant or breastfeeding.
- people of childbearing potential who are sexually active with men and have not used "acceptable contraceptive methods" for at least 2 months prior to enrollment.
- Of "childbearing potential" is defined as beyond onset of menarche and not: menopausal for 2 or more years, post bilateral tubal ligation at 1 year prior, post bilateral oophorectomy for at least 1 year or post...
- "Acceptable birth control methods" include:
- Hormonal contraceptives (such as oral, injection, transdermal patch, implant, cervical ring).
- Barrier method (condom with spermicide or diaphragm with spermicide) every time during intercourse.
- Intrauterine device.
- Monogamous relationship with vasectomized partner (partner must have been vasectomized for at least 6 months prior to the subject's enrollment.
- people of childbearing potential who are sexually active with men and refuse acceptable contraceptive method up to 28 days after the vaccination.
- Any positive or indeterminate pregnancy test.
- Planned vaccination (during the trial conduct) against any other vaccine preventable disease.
- Planned travel (during the trial) to any YFV endemic area.
- Screening serology consistent with prior history of dengue, zika, West Nile or Japanese encephalitis virus infection. It may occur that a prospective subject meets all entry criteria except one that relates to short...
The study team makes the final eligibility decision.
Where it's taking place
- Portland, Oregon, 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, 20 years to 49 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Portland, Oregon, 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.