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Phase Ib trial of folate binding protein (FBP)-derived peptide vaccines, E39 and an attenuated version, E39': An analysis of safety and immune response

Vreeland, Timothy J. et al.

Clinical immunology. Volume 192: (2018, July); pp 6-13 -- Academic

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  • Title:
    Phase Ib trial of folate binding protein (FBP)-derived peptide vaccines, E39 and an attenuated version, E39': An analysis of safety and immune response
  • Author: Vreeland, Timothy J.;
    Litton, Jennifer K.;
    Qiao, Na;
    Philips, Anne V.;
    Alatrash, Gheath;
    Hale, Diane F.;
    Jackson, Doreen O.;
    Peace, Kaitlin M.;
    Greene, Julia M.;
    Berry, John S.;
    Clifton, Guy T.;
    Peoples, George E.;
    Mittendorf, Elizabeth A.
  • Found In: Clinical immunology. Volume 192: (2018, July); pp 6-13
  • Journal Title: Clinical immunology
  • Subjects: Immunologic diseases--Periodicals; Immunopathology--Periodicals; FBP--GM-CSF--CTL--PVS--DTH--R0--RC1--RC6--V1–6; Folate binding protein--Breast cancer--Ovarian cancer--Peptide vaccine--Attenuated vaccine--Activation induced cell death; Dewey: 616.07905
  • Rights: Licensed
  • Publication Details: Academic
  • Abstract: Abstract In this randomized phase Ib trial, we tested combining the E39 peptide vaccine with a vaccine created from E39', an attenuated version of E39. Patients with breast or ovarian cancer, who were disease-free after standard of care therapy, were enrolled and randomized to one of three arms. Arm EE received six E39 inoculations; arm EE' received three E39 inoculations followed by three E39'; and arm E'E received three E39' inoculations, followed by three E39. Within each arm, the first five patients received 500 μg of peptide and the remainder received 1000 μg. Patients were followed for toxicity, and immune responses were measured. This initial analysis after completion of the primary vaccination series has confirmed the safety of both vaccines. Immune analyses suggest incorporating the attenuated version of the peptide improves immune responses and that sequencing of E39 followed by E39' might produce the optimal immune response. Trial Registration:NCT02019524 Highlights FBP-derived peptide vaccine E39 elicits a strong in vivo immune response. Highly immunogenic vaccines may overstimulate the immune system. E39' (attenuated E39) is being tested in a phase Ib trial. E39 and E39' are safe with local and systemic toxicities ≤ grade 2. Sequencing E39 followed by E39' may elicit optimal immune response.
  • Identifier: System Number: ETOCvdc_100059913744.0x000001; Journal ISSN: 1521-6616; doi/10.1016/j.clim.2018.03.010
  • Publication Date: 2018
  • Physical Description: Electronic
  • Shelfmark(s): 3286.291550
  • UIN: ETOCvdc_100059913744.0x000001

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