drugset / Trial / NCT00988559
Therapeutic Vaccination for Patients With HPV16+ Cervical Intraepithelial Neoplasia (CIN2/3)
Phase 1
Completed
132 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI) · collabNational Institutes of Health (NIH) · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study will test the efficacy and safety of different routes of administration of a DNA vaccine in patients with HPV16+ CIN2/3. Subjects will be enrolled in one of six treatment groups. Subjects enrolled in the first two groups will receive vaccination intradermally with a needle-free delivery device. Subjects enrolled in groups 3 and 4 will receive vaccination intramuscularly. Subjects enrolled in groups 5 and 6 will receive vaccine intralesionally.
Timeline
- Start
- 2009-09
- Primary completion
- 2016-07
- Completion
- 2016-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Imiquimod | Other / unclassified | — | Topical |
| Subject | pNGVL4a-CRT/E7(detox) | Vaccine | 8 ug | Intramuscular |
| Subject | pNGVL4a-CRT/E7(detox) | Vaccine | 16 ug | Intramuscular |
| Subject | pNGVL4a-CRT/E7(detox) | Vaccine | 1 mg | Intramuscular |
| Subject | pNGVL4a-CRT/E7(detox) | Vaccine | 3 mg | Intramuscular |