Safety and Immunogenicity of a Melan-A VLP Vaccine in Early Stage Melanoma Patients

Exclusion Criteria

• •Pregnant or nursing
• •Use of an investigational drug within 30 days before enrolment
• •Active malignancy in the 5 years prior to enrollment other than melanoma, basal cell carcinoma or cervical carcinoma in situ.
• •Major surgery within 4 weeks prior to enrollment.
• •Current use of an immunosuppressive drug or any concomitant medication that could potentially interfere with the study drug (e.g. steroids, antihistamine drugs; topical or inhalational steroids are permitted).
• •Presence of significant cardiovascular, renal, pulmonary, endocrine, infectious, or neurological disorders.
• •Serum tests positive for HIV, HBV, HCV.
• •Active autoimmune diseases or severe allergies.
• •Current diagnosis or history of relevant and severe psychiatric disorder that compromises the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol or to complete the study.
• •Blood donation or loss of \> 500mL within 8 weeks prior to inclusion.
• •Abuse of alcohol or other recreational drugs.
• •Previous vaccination with a Melan-A analog peptide.