Frontiers in Oncology (Feb 2019)

Safety and Therapeutic Profile of a GnRH-Based Vaccine Candidate Directed to Prostate Cancer. A 10-Year Follow-Up of Patients Vaccinated With Heberprovac

  • Jesús A. Junco,
  • Ranfis Rodríguez,
  • Franklin Fuentes,
  • Idania Baladrón,
  • Maria D. Castro,
  • Lesvia Calzada,
  • Carmen Valenzuela,
  • Eddy Bover,
  • Eulogio Pimentel,
  • Roberto Basulto,
  • Niurka Arteaga,
  • Angel Cid-Arregui,
  • Francisco Sariol,
  • Lourdes González,
  • Liliana Porres-Fong,
  • María Medina,
  • Ayni Rodríguez,
  • A. Hilda Garay,
  • Osvaldo Reyes,
  • Matilde López,
  • Lourdes de Quesada,
  • Allelin Alvarez,
  • Carolina Martínez,
  • Marleny Marrero,
  • Guillermo Molero,
  • Alfredo Guerra,
  • Pedro Rosales,
  • Carlos Capote,
  • Sahily Acosta,
  • Idania Vela,
  • Lina Arzuaga,
  • Ana Campal,
  • Erlán Ruiz,
  • Elier Rubio,
  • Pável Cedeño,
  • María Carmen Sánchez,
  • Pedro Cardoso,
  • Rolando Morán,
  • Yairis Fernández,
  • Magalys Campos,
  • Henio Touduri,
  • Dania Bacardi,
  • Indalecio Feria,
  • Amilcar Ramirez,
  • Karelia Cosme,
  • Pedro López Saura,
  • Maricel Quintana,
  • Verena Muzio,
  • Ricardo Bringas,
  • Marta Ayala,
  • Mario Mendoza,
  • Luis E. Fernández,
  • Adriana Carr,
  • Luis Herrera,
  • Luis Herrera,
  • Gerardo Guillén

DOI
https://doi.org/10.3389/fonc.2019.00049
Journal volume & issue
Vol. 9

Abstract

Read online

Heberprovac is a GnRH based vaccine candidate containing 2.4 mg of the GnRHm1-TT peptide as the main active principle; 245 μg of the very small size proteoliposomes adjuvant (VSSP); and 350 μL of Montanide ISA 51 VG oil adjuvant. The aim of this study was to assess the safety and tolerance of the Heberprovac in advanced prostate cancer patients as well as its capacity to induce anti-GnRH antibodies, the subsequent effects on serum levels of testosterone and PSA and the patient overall survival. The study included eight patients with histologically-proven advanced prostate cancer with indication for hormonal therapy, who received seven intramuscular immunizations with Heberprovac within 18 weeks. Anti-GnRH antibody titers, testosterone and PSA levels, as well as clinical parameters were recorded and evaluated. The vaccine was well tolerated. Significant reductions in serum levels of testosterone and PSA were seen after four immunizations. Castrate levels of testosterone were observed in all patients at the end of the immunization schedule, which remained at the lowest level for at least 20 months. In a 10-year follow-up three out of six patients who completed the entire trial survived. In contrast only one out eight patients survived in the same period in a matched randomly selected group receiving standard anti-hormonal treatment. Heberprovac vaccination showed a good security profile, as well as immunological, biochemical and, most importantly, clinical benefit. The vaccinated group displayed survival advantage compared with the reference group that received standard treatment. These results warrant further clinical trials with Heberprovac involving a larger cohort.

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