J Gynecol Oncol.
2019 Nov;30(6):e88. 10.3802/jgo.2019.30.e88.
A phase 1/2a, dose-escalation, safety and preliminary efficacy study of oral therapeutic vaccine in subjects with cervical intraepithelial neoplasia 3
- Affiliations
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- 1BioLeaders Corporation, Yongin, Korea.
- 2Department of Obstetrics and Gynecology, Korea University Guro Hospital, College of Medicine, Korea University, Seoul, Korea. jklee38@gmail.com
- 3Department of Bio and Fermentation Convergence Technology, Kookmin University, Seoul, Korea.
- 4General Hospital and Women's Healthcare Center, Dankook University College of Medicine, Seoul, Korea.
- 5Department of Obstetrics and Gynecology, Keimyung University, School of Medicine, Daegu, Korea.
- 6Department of Obstetrics and Gynecology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea. jspark@catholic.ac.kr
- KMID: 2458895
- DOI: http://doi.org/10.3802/jgo.2019.30.e88
Abstract
OBJECTIVE
Persistent infection of HPV increases the chance of carcinoma in situ of cervix through stages of cervical intraepithelial neoplasia (CIN) 1, 2, and 3, and finally progresses into cervical cancer. We aimed to explore the safety and efficacy of BLS-M07 which is orally administered agent expressing human papillomavirus (HPV) 16 E7 antigen on the surface of Lactobacillus casei in patients with CIN 3.
METHODS
Patients with CIN 3 were recruited in our clinical trial. Reid Colposcopic Index (RCI) grading and serum HPV16 E7 specific antibody production were used to evaluate efficacy of BLS-M07. In phase 1, BLS-M07 was administered orally, 5 times a week, on weeks 1, 2, 4, and 8 with dosages of 500 mg, 1,000 mg, and 1,500 mg. In phase 2a, patients were treated with 1,000 mg. The primary endpoints were the safety and the pathologic regression on colposcopic biopsy.
RESULTS
Nineteen patients were enrolled in the CIN 3 cohort. In phase 1, no patients experienced dose limiting toxicity. No grade 3 or 4 treatment-related adverse events or deaths were observed. At 16 weeks after treatment, RCI grading was improved and serum HPV16 E7 specific antibody production increased (p<0.05). Six of 8 (75%) patients with CIN 3 were cured in phase 2a.
CONCLUSIONS
Oral immunization with BLS-M07 increases production of serum HPV16 E7 specific antibody which induces protective humoral immunity. The safety of this oral vaccine was proved and could be a competitive non-surgical therapeutic agent of CIN 3. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02195089
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