Phase I Clinical Trial of a Therapeutic Vaccine for Malignancies, Comprising the Tumor Antigen NY-ESO-1 in Combination With the Adjuvant MPLA of Bordetella Pertussis. Evaluation of Toxicity and Immunogenicity
The safety and immunogenicity of the vaccine with the antigen NY-ESO-1 in combination with
the MPLA will be evaluated in a phase 1 clinical trial conducted in patients with
malignancies that express the antigen (lung, ovarian and melanoma). This study will involve
15 patients, who will receive 250 mcg of NY-ESO-1 and 100 mcg of MPLA.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
CTCAE (Common Terminology Criteria for Adverse Events)
Six months after immunization.
Pedro Giavina-Bianchi, MD,PhD
University of São Paulo
Brazil: National Health Surveillance Agency