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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
NameTimeMethod
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
NameTimeMethod
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.
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