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

Clin Immunol. 2018 Jul;192:6-13. doi: 10.1016/j.clim.2018.03.010. Epub 2018 Mar 21.

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.

Keywords: Activation induced cell death; Attenuated vaccine; Breast cancer; Folate binding protein; Ovarian cancer; Peptide vaccine.

Publication types

  • Clinical Trial, Phase I
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Breast Neoplasms / immunology*
  • Breast Neoplasms / therapy
  • Cancer Vaccines / administration & dosage
  • Cancer Vaccines / adverse effects
  • Cancer Vaccines / immunology*
  • Female
  • Folate Receptors, GPI-Anchored / immunology*
  • Humans
  • Hypersensitivity, Delayed / etiology
  • Hypersensitivity, Delayed / immunology
  • Middle Aged
  • Ovarian Neoplasms / immunology*
  • Ovarian Neoplasms / therapy
  • T-Lymphocytes, Cytotoxic / drug effects
  • T-Lymphocytes, Cytotoxic / immunology
  • Vaccination / methods
  • Vaccines, Attenuated / administration & dosage
  • Vaccines, Attenuated / immunology
  • Vaccines, Subunit / administration & dosage
  • Vaccines, Subunit / adverse effects
  • Vaccines, Subunit / immunology*

Substances

  • Cancer Vaccines
  • Folate Receptors, GPI-Anchored
  • Vaccines, Attenuated
  • Vaccines, Subunit

Associated data

  • ClinicalTrials.gov/NCT02019524