Table 3.
Viral-Vectored Vaccines
| NCT # | Phase | Name of Trial | Vaccine | Route of Admin. | Type of HPV Malignancy | n | Outcome Measures | Sponsor | Status |
|---|---|---|---|---|---|---|---|---|---|
| NCT03141463 | I | Vvax001 Cancer Vaccine in (Pre) Malignant Cervical Lesions | Vvax001 | – | CIN 2/3; cervical cancer | 12 | 1: Immunogenicity. 2: Treatment related AE. | University Medical Center Groningen; Dutch Cancer Society;ViciniVax B.V. | Completed |
| NCT03610581 | I/II | Safety, Reactogenicity and Immunogenicity of Adenovirus Serotype 26 (Ad26)- and Modified Vaccinia Ankara (MVA)-Vectored Vaccine Components in Otherwise Healthy Women with HPV16 or HPV18 Infection of the Cervix | Ad.26HPV 16/18 plus MVAHPV16/18 | I.M. | HPV16 or 18 infection of the cervix | 66 | 1: Percentage of participants with AE. 2: Percentage of participants with HPV-specific T-cell responses, clinical immunology. | Janssen Vaccines & Prevention B.V.; Bavarian Nordic | Recruiting Completion Dec 2022 |
| NCT04180215 | I/II | A Study of HB-201 Alone or in Combination with a Checkpoint Inhibitor in Patients With Human Papillomavirus 16 Positive (HPV 16+) Confirmed Cancers | HB-201 | I.M. I.V. | HPV16+ cancer | 100 | 1: Phase II dose for both routes of administration. 2: AE, tumor responses, clinical immunology. | Hookipa Biotech | Recruiting Completion Jun 2022 |
| NCT01022346 | II | A Study of RO5217790 in Participants with High Grade Cervical Intraepithelial Neoplasia (CIN) Associated With High Risk Human Papillomavirus (HR-HPV) Infection | RO5217790 | S.C. | CIN 2/3 | 206 | 1: Histological resolution of CIN. 2: Percentage of patients with histological resolution, histological response, viral clearance, immunologic response, AE. | Hoffman-La Roche | Completed |
| NCT00002916 | II | Surgery and Vaccine Therapy in Treating Patients with Early Cervical Cancer | TA-HPV | – | Untreated stage Ib or IIa cervical carcinoma, squamous or adenocarcinoma suitable for surgical excision | 44 | 1: Immunological response to HPV, toxicity and safety of TA-HPV. 2: T-cell proliferative capacity to E6/E7, disease-free interval. | European Organisation for Research and Treatment of Cancer (EORTC) | Completed |
Abbreviations: AE, adverse event; CIN, cervical intraepithelial neoplasia; I.M., intramuscular; I.V., intravenous; S.C., subcutaneous.