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A randomized controlled trial to compare the immunogenicity and skin imprinting of intradermal, subcutaneous and intramuscular yellow fever vaccination
EU CTIS ID: 2024-514154-73-00
What this study is testing
To compare the number and proportion of skin-resident memory T cells against YFV (YFV-TRM) after YF vaccination by vaccination route at D28.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- >/=18 to ≤50 years of age
- BMI >/=18,5 kg/m2 and ≤35 kg/m2
- Agreement to refrain from blood donation and other vaccinations 30 days following vaccination
- Agreement to share and discuss participant’s medical history and medical records when relevant
- Able and willing to provide written informed consent
- Willing to use a highly effective method of contraception up to 30 days after study vaccination (in case of women with childbearing potential).
You likely can't join if
- Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature ≥38.0ºC within 24 hours prior to the planned dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator
- Breastfeeding, pregnancy or planning to become pregnant up to 30 days after the study vaccination
- Tendency to keloid (scar) formation in response to skin damage
- Skin diseases or tattoo at the biopsy or vaccination site
- In the opinion of the investigator, unlikely compliance to the requirements of the study
- Receipt of any vaccine (licensed or experimental) within 30 days prior to enrolment
See the full eligibility criteria
Who can join
- >/=18 to ≤50 years of age
- BMI >/=18,5 kg/m2 and ≤35 kg/m2
- Agreement to refrain from blood donation and other vaccinations 30 days following vaccination
- Agreement to share and discuss participant’s medical history and medical records when relevant
- Able and willing to provide written informed consent
- Willing to use a highly effective method of contraception up to 30 days after study vaccination (in case of women with childbearing potential).
What rules you out
- Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature ≥38.0ºC within 24 hours prior to the planned dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator
- Breastfeeding, pregnancy or planning to become pregnant up to 30 days after the study vaccination
- Tendency to keloid (scar) formation in response to skin damage
- Skin diseases or tattoo at the biopsy or vaccination site
- In the opinion of the investigator, unlikely compliance to the requirements of the study
- Receipt of any vaccine (licensed or experimental) within 30 days prior to enrolment
- Active participation in another interventional clinical study with active substance intake or large medical procedures affecting the study procedures during the trial or 1 month prior to enrolment
- Individuals who are working at the investigational site or within the research team of this study and their close relatives
- Subjects with a confirmed flavivirus infection in the past
- Subjects who already received a flavivirus vaccination prior to enrolment or are planning a flavivirus vaccination during the course of the trial other than the study vaccination.
- Subjects who received immunoglobulins and/or any blood or blood derived products within 3 months preceding study vaccination (or planned administration during the study)
- Any confirmed or suspected immunosuppressive or immunodeficient state (incl. cancer and HIV/HBV infection); asplenia; recurrent severe infections and use of immunosuppressant medication (including antineoplastic and immunomodulating agents or radiotherapy) within the last 6 months prior to enrolment, except topical or short-term oral steroids (<2 weeks of daily receipt of 20 mg of prednisone or equivalent). Refer to annex 1 for a list of immunosuppressive medication
- Subjects who are currently on anticoagulant therapy
- Subjects who are continuously using systemic antivirals
- Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, psychiatric and neurological illness (mild/moderate well controlled comorbidities are allowed)
- History of anaphylaxis, allergic disease or reactions to any component of the study vaccine, including eggs or chicken proteins
- History of acute polyneuropathy (eg, Guillain-Barré syndrome)
- History of bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections, SC injections or venipuncture
- History of thymus dysfunction (including myasthenia gravis, thymoma) or thymectomy
- Any other significant disease, disorder, planned surgery, or finding which may significantly affect the ability of the volunteer to participate in the study or impair interpretation of the study data
- Suspected or known alcohol or drug dependency
The study team makes the final eligibility decision.
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, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.