Vaccin tracking in healthy volunteers
Completed
- Conditions
- Human Papilloma Virus 16 Peptide vaccinFluorescencePharmacokinetics
- Registration Number
- NL-OMON23478
- Lead Sponsor
- Centre for Human Drug Research (CHDR)Leiden University Medical Center (LUMC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
1.The subject is 18-65 years old at screening.
2.The subject is able and willing to comply with study procedures, and signed and dated
informed consent is obtained before any study-related procedure is performed.
Exclusion Criteria
1.The subjects uses prescription drugs or OTC-drugs that may have an impact on the study objectives.
2.Previous exposure to the investigational drug.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment-emergent (serious) adverse events ((S)AEs); concomitant medication; clinical laboratory tests (haematology, chemistry, urinalysis); vital signs (pulse rate, systolic blood pressure, diastolic blood pressure); injection site status; physical examination findings.<br>
- Secondary Outcome Measures
Name Time Method The following endpoints will be determined for HPV-NIRD1 following administration, they will be derived by imaging of injection site and draining inguinal lymph nodes:<br>„XAbsolute fluorescent signal of injection site or draining inguinal lymph node at different time points and doses<br>„XSBR (signal to background ratio), defined as fluorescent signal of injection site or draining inguinal lymph node compared to fluorescence signal of tissue surrounding the injection side or lymph node, at different time points and doses.