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

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 information

1
Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, 1400 Pressler St, Unit 1484, Houston, TX 77030, United States. Electronic address: tjvreeland@mdanderson.org.
2
Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, 1155 Pressler St, Unit 1354, Houston, TX 77030, United States. Electronic address: jlitton@mdanderson.org.
3
Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, 1400 Pressler St, Unit 1434, Houston, TX 77030, United States. Electronic address: nqiao@mdanderson.org.
4
Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, 1400 Pressler St, Unit 1434, Houston, TX 77030, United States. Electronic address: avphilips@mdanderson.org.
5
Department of Stem Cell Transplantation and Cellular Therapy, The University of MD Anderson Cancer Center, 1515 Holcombe Blvd, Unit 423, Houston, TX 77030, United States. Electronic address: galatras@mdanderson.org.
6
Department of Surgery, San Antonio Military Medical Center, 3551 Roger Brooke Dr, San Antonio, TX 78234, United States. Electronic address: diane.f.hale.mil@mail.mil.
7
Department of Surgery, San Antonio Military Medical Center, 3551 Roger Brooke Dr, San Antonio, TX 78234, United States. Electronic address: Doreen.o.jackson.mil@mail.mil.
8
Department of Surgery, San Antonio Military Medical Center, 3551 Roger Brooke Dr, San Antonio, TX 78234, United States. Electronic address: Kaitlin.m.peace.mil@mail.mil.
9
Department of Surgery, San Antonio Military Medical Center, 3551 Roger Brooke Dr, San Antonio, TX 78234, United States. Electronic address: Julia.m.greene.mil@mail.mil.
10
Department of Surgery, Womack Army Medical Center, 2817 Reilly Rd, Fort Bragg, NC 28310, United States. Electronic address: john.s.berry.mil@mail.mil.
11
Department of Surgery, San Antonio Military Medical Center, 3551 Roger Brooke Dr, San Antonio, TX 78234, United States. Electronic address: Guy.t.clifton.mil@mail.mil.
12
Department of Surgery, Uniformed Services University of the Health Sciences, 4301 Jones Bridge Rd, Bethesda, MD 20814, United States.
13
Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, 1400 Pressler St, Unit 1434, Houston, TX 77030, United States. Electronic address: emittendorf@bwh.harvard.edu.

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

PMID:
29574039
PMCID:
PMC5988975
[Available on 2019-07-01]
DOI:
10.1016/j.clim.2018.03.010

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