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Therapeutic Areas: Oncology | Obstetrics/Gynecology (Women’s Health)
Disease Category: Cervical Intraepithelial Neoplasia
Location: United States, FL
Vaccine for Patients Who Have an Abnormal PAP Smear (Cervical Intraepithelial Neoplasia Grade 2 or 3)
This study for women who have recently had an abnormal PAP smear showing cervical intraepithelial neoplasia grade 2 or 3.
This study is testing the effectiveness of a vaccine in treating the cervix and preventing infection in the future. The vaccine is composed of Listeria, a living bacteria that produces a substance naturally produced by the virus causing the cervical neoplasia. The bacteria will cause the patient's body to produce antibodies and build up a natural immunity against the virus causing the cervical neoplasia. Thus, the body should be able to naturally reverse the neoplasia and attack the virus if the patient is re-infected in the future.
Patients will receive the vaccine three times at weeks 1, 4, & 8. The patient will then have surgery to remove the neoplasia. This surgery is standard procedure and will be performed on the patient at no cost to the patient. The patient will also undergo a colposcopy, cervical biopsy, and anergy test at no cost. The patient will have six visits in total, the last one at six months after the operation. The patient will be compensated $50 per visit ($300 total).
Patient Inclusion Criteria:
- 18 years of age or older
- pregnant woman between 16-20 weeks who have previously had a spontaneous preterm labor
Patient Exclusion Criteria:
- women expecting twins, triplets, etc.
- women currently receiving progesterone or heparin treatment
Rossmeri Montalvo, Site Director
4671 S. Congress Ave
Lake Worth, FL 33461
Phone: (561) 641-0404
Fax: (561) 641-0345
Research Center Information: Altus Research
If you would like to learn more about participating in this study, please send an email message using the form below.
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