A Placebo-Controlled, Double-Blind Randomized (Phase IIB) Trial of Oral Administration with HPV16 E7-Expressing
| Autor: | Katsutoshi Oda, Atsushi Komatsu, Ai Kawana-Tachikawa, Kei Kawana, Tomoyuki Fujii, Ayumi Taguchi, Yutaka Osuga, Yukari Uemura, Katsuyuki Adachi, Takeshi Nagamatsu, Yuji Ikeda, Tetsushi Tsuruga, Mayuyo Uchino-Mori, Shizunobu Igimi, Kensuke Tomio, Satoko Eguchi-Kojima |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
cervical cancer viruses Immunology lcsh:Medicine Human Papillomavirus (HPV) Placebo Cervical intraepithelial neoplasia Gastroenterology Peripheral blood mononuclear cell Article law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Oral administration Internal medicine Drug Discovery medicine Clinical endpoint Pharmacology (medical) 030212 general & internal medicine Adverse effect neoplasms Pharmacology Cervical cancer business.industry lcsh:R virus diseases medicine.disease Cervical Intraepithelial Neoplasia 2 (CIN2) female genital diseases and pregnancy complications lactobacillus-based vaccine Infectious Diseases 030220 oncology & carcinogenesis mucosal immunity therapeutic vaccine business |
| Zdroj: | Vaccines Volume 9 Issue 4 Vaccines, Vol 9, Iss 329, p 329 (2021) |
| ISSN: | 2076-393X |
| Popis: | Cervical intraepithelial neoplasia (CIN), a precursor lesion to cervical cancer, is caused by high-risk human papillomavirus (HPV) high-grade CIN lesions (CIN2-3) are precancerous and require treatment. No globally approved therapy is available for CIN2-3 treatment. This study is a placebo-controlled randomized clinical trial of GLBL101c treatment for CIN2 in 40 patients with HPV16-positive CIN2 who were 1:1 randomized to receive GLBL101c (1 g/daily) or placebo for 5 days at 1, 2, 4, and 8 weeks. No differences were noted between the GLBL101c and placebo groups for patient background and adverse events. Moreover, no statistically significant difference was noted between the two groups at the primary endpoint, pathological regression after 16 weeks of the first oral dose however, only in the GLBL101c group, two patients had complete regression (CR regression to normal within 16 weeks). IFNγ production was significantly correlated with the number of spots identified by the interferon gamma enzyme-linked immunospot (IFNγ-ELISPOT) assay using cervical lymphocytes (CxLs) or peripheral blood mononuclear cells. In the two cases of CR, E7-specific Th1 immune responses were observed at week 16. Therefore, we concluded as a novel Lactobacillus-based vaccine with stronger immunogenicity than GLBL101c should be developed. |
| Databáze: | OpenAIRE |
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