UNASSIGNED: 7503 Background: To evaluate the immunogenicity of 12 peptides from @entity5 and melanocyte differentiation proteins, and to assess the feasibility of complex peptide vaccines, a randomized phase II trial was performed in 51 @entity1 with resected high-risk @entity320 . METHODS: Arm 1 received 4 peptides and arm 2 received 12 peptides. Each vaccine was an emulsion of 4 or 12 peptides (100ug each), a @entity116 helper peptide (190ug), Montanide ISA-51 adjuvant (1 ml), and @entity2841 (110 ug). T-cell responses were evaluated in peripheral blood lymphocytes and in a sentinel immunized node by IFNy ELIspot assay after one in vitro sensitization. RESULTS: All @entity1 have completed treatment; immunologic assessment is complete on 31 @entity1 . Preliminary data from these 31 @entity1 reveal immune responses in 11/14 @entity1 (79%) on arm 1 and 17/17 @entity1 (100%) on arm 2. Responses to 9 of the peptides are shown (Table). @entity1 on arm 2 responded to an average of 2.8 different peptides, those on arm 1 responded to an average of only 0.9 peptides. By comparing T cell responses to three index peptides in both peptide mixtures, it will be possible to assess whether co-administration of 4 peptides binding the same MHC molecule interferes with immunogenicity of the index peptides. Current results indicate that the median of the best immune responses for index peptides (fold-increase over background) was 9.7 in arm 1 and 11.1 in arm 2. The mean number of responses to index peptides per @entity1 was 0.7 for Group 1, and 1.1 for Group 2. CONCLUSIONS: These findings support that (1) the most immunogenic peptides in this study were from @entity11442 , @entity9857 , @entity6472 , and MAGE-A10; (2) multiple peptides can be administered in combined aqueous mixture with safety and immunogenicity, and (3) immunogenicity is maintained despite peptide competition for binding to MHC. Further investigation of multiple-peptide vaccine mixtures is warranted. [Figure: see text] [Table: see text].

Immunological results of a phase II randomized trial of multipeptide vaccines for XXXX .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient'] @entity9857 :: ('6490', 'Gene') :: ['gp100'] @entity5 :: ('MESH:D009369', 'Disease') :: ['cancer-testis'] @entity6472 :: ('4100', 'Gene') :: ['MAGE-A1'] @entity116 :: ('MESH:D013746', 'Disease') :: ['tetanus'] @entity11442 :: ('7299', 'Gene') :: ['tyrosinase'] @entity2841 :: ('1437', 'Gene') :: ['GM-CSF'] @entity320 :: ('MESH:D008545', 'Disease') :: ['melanoma']
@entity320 :: (MESH:D008545,Disease) :: ['melanoma']
