HPV Anti-CD40 RNA Vaccine (HARE-40)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03418480|
Recruitment Status : Suspended (Temporary suspension due to COVID-19 pandemic)
First Posted : February 1, 2018
Last Update Posted : March 26, 2020
HARE-40 is a phase I/II vaccine dose escalation study with two different arms: Arm 1A will perform intrapatient dose escalation in patients with previously treated HPV16+ Head & Neck Cancer using two dose cohorts to establish a safe, tolerable and recommended dose of HPV vaccine.
Arm 1B will perform intrapatient dose escalation in patients with advanced HPV16+ cancer (head and neck, anogenital, penile or cervical) using a single cohort to establish a safe, tolerable and recommended dose of HPV vaccine.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Squamous Cell Head and Neck Neoplasm Cervical Neoplasm Penile Neoplasms Malignant||Drug: HPV vaccine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Therapeutic HPV Vaccine Trial +/- Anti-CD40 in HPV-driven Squamous Cell Carcinoma|
|Actual Study Start Date :||April 11, 2017|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: RNA Vaccine A
Arm 1A: 15 (6+9) patients with previously treated HPV16+ head and neck squamous cell carcinoma receiving increasing doses of HPV vaccine.
Drug: HPV vaccine
Experimental: RAN Vaccine B
Arm 1B: 29 (15+14) patients with HPV16+ advanced disease receiving increasing doses of HPV vaccine.
Drug: HPV vaccine
- Dose Limiting Toxicity (DLT) according to CTCAE version 4.03 (Arm 1A) [ Time Frame: 3 months ]Safe and tolerable dose of clinically disease free patients (Arm 1A) - Determination of a suitable dose of HPV RNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418480
|Univeristy Hospitals Southampton NHS Foundation Trust|
|Southampton, Hampshire, United Kingdom, SO16 6YD|
|Principal Investigator:||Christian Ottensmeier, Prof||University Hospitals Southampton NHS Foundation Trust|