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Models and Technologies

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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Sedigheh Taghinezhad-S
1Department 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 Keyvanlab@yahoo.com
Hossein Keyvani
2Department of Virology, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran.
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  • For correspondence: s.taghinezhad@srbiau.ac.ir Keyvanlab@yahoo.com
DOI: 10.1158/1535-7163.MCT-19-0375 Published February 2020
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    Figure 1.

    Flowchart of participants enrolled in this study and reasons for exclusion.

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    Figure 2.

    HPV-16 E7-specific serum IgG antibody (1, top) and E7-specific vaginal IgA antibody (2, bottom) levels by placebo groups [cohorts 1 (A, left); 1 × 109 CFU/mL dose, cohorts 2 (B, center); 5 × 109 CFU/mL dose, and cohorts 3 (C, right); 1 × 1010 CFU/mL dose] and vaccine group [cohorts 4 (A, left); 1 × 109 CFU/mL dose, cohorts 5 (B, center); 5 × 109 CFU/mL dose, and cohorts 6 (C, right); 1 × 1010 CFU/mL dose] measured by ELISA at a serum dilution of 1:100 using goat anti-human IgG H&L (HRP) antibody and at a vaginal fluid dilution of 1:10 using goat anti-human IgA alpha chain (HRP) antibody, respectively. Results are expressed with 95% CIs for the following time points: prevaccination (day 0), days 30, 60, 90, and 240. The absorbance of each well was measured at 450 nm. Bars represent the mean ± standard error value of each group. Statistically significant differences are denoted by an asterisk between T60 and T30, T90, and T240 of vaccine groups (*, P ≤ 0.0001; **, P ≤ 0.001; ***, P ≤ 0.05; ****, P ≤ 0.1).

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    Figure 3.

    E711–20-specific IFNγ-secreting CD8+ CTL responses in cervical lymphocytes (1, top) and PBMCs (2, bottom) for samples from the same donor; placebo groups [cohorts 1 (A, left); 1 × 109 CFU/mL dose, cohorts 2 (B, center); 5 × 109 CFU/mL dose, and cohorts 3 (C, right); 1 × 1010 CFU/mL dose] and vaccine group [cohorts 4 (A, left); 1 × 109 CFU/mL dose, cohorts 5 (B, center); 5 × 109 CFU/mL dose, and cohorts 6 (C, right); 1 × 1010 CFU/mL dose] at different time points; before (day 0) and after immunizations (days 30, 60, 90, and 240). Each sign represents one woman. Data are reported as mean ± SD. Results are expressed as spot‐forming cells per number of cells with 95% CIs. Statistically significant differences are denoted by an asterisk between T90 and T30, T60, and T240 of vaccine groups (*, P ≤ 0.0001; **, P ≤ 0.001; ***, P ≤ 0.05; ****, P ≤ 0.1; *****, P ≤ 1).

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    Figure 4.

    E749–57-specific IFNγ-secreting CD8+ CTL responses in cervical lymphocytes (1, top) and PBMCs (2, bottom) for samples from the same donor; placebo groups [cohorts 1 (A, left); 1 × 109 CFU/mL dose, cohorts 2 (B, center); 5 × 109 CFU/mL dose, and cohorts 3 (C, right); 1 × 1010 CFU/mL dose] and vaccine group [cohorts 4 (A, left); 1 × 109 CFU/mL dose, cohorts 5 (B, center); 5 × 109 CFU/mL dose, and cohorts 6 (C, right); 1 × 1010 CFU/mL dose] at different time points; before (day 0) and after immunizations (days 30, 60, 90, and 240). Each sign represents one woman. Data are reported as mean ± SD. Results are expressed as spot‐forming cells per number of cells with 95% CIs. Statistically significant differences are denoted by an asterisk between T90 and T30, T60, and T240 of vaccine groups (*, P ≤ 0.0001; **, P ≤ 0.001; ***, P ≤ 0.05; ****, P ≤ 0.1; *****, P ≤ 1).

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    Figure 5.

    E786–93-specific IFNγ-secreting CD8+ CTL responses in cervical lymphocytes (1, top) and PBMCs (2, bottom) for samples from the same donor; placebo groups [cohorts 1 (A, left); 1 × 109 CFU/mL dose, cohorts 2 (B, center); 5 × 109 CFU/mL dose, and cohorts 3 (C, right); 1 × 1010 CFU/mL dose] and vaccine group [cohorts 4 (A, left); 1 × 109 CFU/mL dose, cohorts 5 (B, center); 5 × 109 CFU/mL dose, and cohorts 6 (C, right); 1 × 1010 CFU/mL dose] at different time points; before (day 0) and after immunizations (days 30, 60, 90, and 240). Each sign represents one woman. Data are reported as mean ± SD. Results are expressed as spot‐forming cells per number of cells with 95% CIs. Statistically significant differences are denoted by an asterisk between T90 and T30, T60, and T240 of vaccine groups (**, P ≤ 0.001; ***, P ≤ 0.05; ****, P ≤ 0.1; *****, P ≤ 1).

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    Figure 6.

    Assessment of logarithm 10 E711–20‐ (1-A), E749–57- (1-B), and E786–93- (1-C) specific IFNγ-secreting CD8+ CTL in cervical lymphocytes, and serum IgG (2-A), and vaginal IgA (2-B) responding to NZ8123-HPV16-optiE7 vaccine between participants of two age arms (A: 20–25 years and B: 26–59 years). Statistically significant differences are denoted by an asterisk between subjects ages 20 to 25 years and subjects ages 26 to 59 years (**, P ≤ 0.001; ***, P ≤ 0.05; ****, P ≤ 0.1; *****, P ≤ 1).

Tables

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  • Table 1.

    Baseline characteristics of healthy women subjects by vaccination dose group at enrollment visit (per-protocol population).

    Study arm
    Vaccine groups (CFU/mL dose)Placebo groups (CFU/mL dose)
    1 × 1095 × 1091 × 10101 × 1095 × 1091 × 1010
    (n = 8)(n = 9)(n = 9)(n = 5)(n = 4)(n = 5)
    DemographicStatusNumber (percentage)
    Age18–25 years2 (25%)3 (33.33%)3 (33.33%)3 (60%)1 (25%)0 (0%)
    26–35 years2 (25%)2 (22.22%)3 (33.33%)0 (0%)1 (25%)3 (60%)
    36–46 years3 (37.50%)1 (11.11%)1 (11.11%)1 (20%)1 (25%)0 (0%)
    47–59 years1 (11.50%)3 (33.33%)2 (22.22%)1 (20%)1 (25%)2 (40%)
    Marital statusMarried6 (75%)6 (66.66%)4 (44.44%)3 (60%)1 (25%)3 (60%)
    Divorce—widow2 (25%)1 (11.11%)1 (11.11%)1 (20%)2 (40%)2 (40%)
    Single0 (0%)2 (22.22%)4 (44.44%)1 (20%)1 (25%)0 (0%)
    BMIUnderweight = <18.51 (11.50%)1 (11.11%)3 (33.33%)1 (20%)1 (25%)0 (0%)
    Normal weight = 18.5–24.91 (11.50%)4 (44.44%)0 (0%)2 (40%)0 (0%)0 (0%)
    Overweight = 25–29.93 (37.50%)1 (11.11%)2 (22.22%)0 (0%)2 (50%)3 (60%)
    Obesity = BMI of 30 or greater3 (37.50%)3 (33.33%)4 (44.44%)2 (40%)1 (25%)2 (40%)
    Age at first sexual intercourse≤160 (0%)0 (0%)1 (11.11%)0 (0%)1 (25%)2 (40%)
    174 (50%)5 (55.55%)6 (66.66%)2 (40%)0 (0%)0 (0%)
    181 (12.50%)4 (44.44%)0 (0%)0 (0%)0 (0%)0 (0%)
    193 (37.50%)0 (0%)2 (22.22%)2 (40%)2 (40%)3 (60%)
    20≤0 (0%)0 (0%)0 (0%)1 (20%)1 (25%)0 (0%)
    Smoking statusNever smoked7 (87.50%)6 (66.66%)7 (77.77%)5 (100%)3 (75%)3 (60%)
    Ex-smoker0 (0%)1 (11.11%)0 (0%)0 (0%)0 (0%)1 (20%)
    Current smoker1 (12.50%)2 (22.22%)2 (22.22%)0 (0%)1 (25%)1 (20%)
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Molecular Cancer Therapeutics: 19 (2)
February 2020
Volume 19, Issue 2
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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 February 1 2020 (19) (2) 717-727; 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 February 1 2020 (19) (2) 717-727; DOI: 10.1158/1535-7163.MCT-19-0375
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