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Molecular Cancer Therapeutics
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Research Article

The first clinical use of a recombinant Lactococcus lactis expressing human papillomavirus type 16 E7 oncogene oral vaccine: A phase I safety and immunogenicity trial in healthy women volunteers

Amir Hossein Mohseni, Sedigheh Taghinezhad-S and Hossein Keyvani
Amir Hossein Mohseni
1Department of Microbiology, Faculty of Basic Sciences, Science and Research Branch, Islamic Azad University, Tehran, Iran
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  • ORCID record for Amir Hossein Mohseni
Sedigheh Taghinezhad-S
2Department of Microbiology, Faculty of Basic Sciences, Science and Research Branch, Islamic Azad University, Tehran, Iran.
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  • For correspondence: s.taghinezhad@srbiau.ac.ir
Hossein Keyvani
3Department of Virology, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran.
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DOI: 10.1158/1535-7163.MCT-19-0375
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Abstract

A dose escalation, randomized, double-blind, placebo-controlled phase 1 clinical trial was performed in healthy Iranian volunteer women to assess the safety, tolerability, and immunogenicity of NZ8123-HPV16-optiE7 vaccine involving recombinant Lactococcus lactis expressing the codon optimized HPV-16 E7 oncogene. Fifty-five eligible subjects were divided into six cohorts based on the dosages (1×109 CFU/mL, 5×109 CFU/mL, and 1×1010 CFU/mL) of either vaccine or placebo, which were administrated orally a total of four times at weeks 1, 2, 4, and 8. Then, adverse events, specific serum IgG and vaginal IgA, and E7-specific IFN‐γ‐secreting CD8⁺ CTL responses were evaluated. The vaccination was well tolerated by 40 subjects who completed the immunization schedule, and no serious adverse effects were reported. The IgG and IgA levels peaked at day 60, and the levels for the 5×109 CFU/mL and 1×1010 CFU/mL dose groups were higher than those of the 1×109 CFU/mL dose group. Time-to-peak stimulation in E7-specific IFN‐γ‐secreting CD8⁺ CTL responses was seen in cervical lymphocytes 1 month after the last vaccination. Again, no significant increase was seen in the PBMCs of the same volunteers. CTL responses in cervical lymphocytes and PBMCs at day 90 were markedly higher in the 5×109 CFU/mL and 1×1010 CFU/mL groups than in the 1×109 CFU/mL group, demonstrating the dose-dependency of NZ8123-HPV16-optiE7 vaccine following oral administration. The 6-month follow-up revealed that antibody levels decreased up to day 240; nevertheless, long-term E7-specific IFN‐γ‐secreting CD8⁺ CTL responses were recorded during follow-up. Overall, the safety and immunogenicity profile achieved in this study encourages further phase II trials with the 5×109 CFU/mL dose vaccine.

  • Received April 7, 2019.
  • Revision received September 6, 2019.
  • Accepted October 14, 2019.
  • Copyright ©2019, American Association for Cancer Research.
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This OnlineFirst version was published on October 23, 2019
doi: 10.1158/1535-7163.MCT-19-0375

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The first clinical use of a recombinant Lactococcus lactis expressing human papillomavirus type 16 E7 oncogene oral vaccine: A phase I safety and immunogenicity trial in healthy women volunteers
Amir Hossein Mohseni, Sedigheh Taghinezhad-S and Hossein Keyvani
Mol Cancer Ther October 23 2019 DOI: 10.1158/1535-7163.MCT-19-0375

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The first clinical use of a recombinant Lactococcus lactis expressing human papillomavirus type 16 E7 oncogene oral vaccine: A phase I safety and immunogenicity trial in healthy women volunteers
Amir Hossein Mohseni, Sedigheh Taghinezhad-S and Hossein Keyvani
Mol Cancer Ther October 23 2019 DOI: 10.1158/1535-7163.MCT-19-0375
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Molecular Cancer Therapeutics
eISSN: 1538-8514
ISSN: 1535-7163

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