Clinical Trial of a Therapeutic Vaccine With NY-ESO-1 in Combination With the Adjuvant Monophosphoryl Lipid A (MPLA)
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|ClinicalTrials.gov Identifier: NCT01584115|
Recruitment Status : Unknown
Verified April 2012 by Pedro Giavina-Bianchi, Instituto de Investigação em Imunologia.
Recruitment status was: Not yet recruiting
First Posted : April 24, 2012
Last Update Posted : April 25, 2012
|Condition or disease||Intervention/treatment||Phase|
|Cancer. Melanoma. Ovarian Cancer. Lung Cancer.||Biological: NY-ESO-1 combined with MPLA Biological: NY-ESO-1 combined with MPLA vaccine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||July 2013|
|Estimated Study Completion Date :||July 2013|
NY-ESO-1 combined with MPLA vaccine
Biological: NY-ESO-1 combined with MPLA
Each patient will receive six doses of the formulation, administered intra-muscular, with an interval of 4 weeks between doses, and the first immunization performed 6 weeks after the completion of standard treatment. NY-ESO-1 (250 mcg) amd MPLA (100 mcg).
Biological: NY-ESO-1 combined with MPLA vaccine
Immunization os cancer patients with NY-ESO-1 combined with MPLA vaccine
- Safety [ Time Frame: Six months after immunization. ]CTCAE (Common Terminology Criteria for Adverse Events)
- Immunogenicity [ Time Frame: Six months after immunization. ]IgG against NY-ESO-1 (ELISA). NY-ESO-1-specific T cells CD4+ and CD8+ (ELISPOT and FACs - flow citometry with tetramers).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01584115
|Contact: Pedro Giavina-Bianchi, PhD,MD||(5511) firstname.lastname@example.org|
|Contact: Marcelo V Aun, MD||(5511) email@example.com|
|Hospital das Clinicas da FMUSP||Not yet recruiting|
|São Paulo, Brazil|
|Principal Investigator:||Pedro Giavina-Bianchi, MD,PhD||University of São Paulo|