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The University of Southampton
Southampton Clinical Trials Unit

HARE-40

Title

Therapeutic HPV vaccine trial +/- anti-CD40 in HPV-driven squamous cell carcinoma. 

Description

HARE-40 is a phase I/II vaccine dose escalation study for HPV16+ Squamous Cell Carcinoma.

Objectives

Primary objective

To establish a safe and tolerable dose of the HPV vaccine.

Secondary objectives

Looking at clinical effect in advance HPV-driven cancers and to assess if these clinical effects are linked with immune effects in the blood and tissue.

Trial Design

Each patient will progress through an intra-patient dose escalation for a total of 8 vaccinations, comprising of 4 weekly vaccinations and 4 fortnightly vaccinations. During this time, patients will be expected to stay overnight for a period of 24 hours after the vaccination. Patients will then be followed up for a period of 2 years, attending follow-up visits at regular intervals.

Trial Status

Open to recruitment

Population

Initially, the trial will recruit to two Arms:

  • Arm 1A will recruit 15 patients who have been previously treated for HPV16+ Head and Neck SCC. 
  • Arm 1B will recruit 29 patients with advanced HPV16+ SCC of Head and Neck, Penile, Cervical and Anogential.

Trial Team:

Senior Trial Manager:

Karen Martin

Trial Manager:

Izabela Eberhart

Clinical Data Coordinator:

Kim Mallard

Contact information

For patient referrals to Southampton Investigator Site please contact phaseoneclinic@soton.ac.uk

Email: HARE-40@soton.ac.uk

SAE Reporting:

Email: pv-biontech@pharmsoft.de  

Fax: +49 (0) 231 700 118 68

 

Essential Trial Documents

HARE-40 - Protocol_v12_14-Jan-2022

HARE-40 - BNT113_IB_v11.0_04-Nov-2021

HARE-40 - Arm 1A GP Letter_v5_13-Nov-2020

HARE-40 - Arm 1B GP Letter_v5_13-Nov-2020

HARE-40 - Arm 1A Informed Consent Form_v10_14-Jan-2022

HARE-40 - Arm 1B Informed Consent Form_v12_14-Jan-2022

HARE-40 - Genetic Informed Consent Form_v5 13-Nov-2020

HARE-40 - Arm 1A Patient Information Sheet_v10_14-Jan-2022

HARE-40 - Arm 1B Patient Information Sheet_v12-14-Jan-2022

HARE-40 - Genetic Patient Information Sheet_v5_13-Nov-2020

HARE-40 - Arm 1A Patient Screening Log v6 01-Apr-2019

HARE-40 - Arm 1B Patient Screening Log v1 01-Apr-2019

HARE-40 - Site Delegation Log v1.0 06-Mar-2017

HARE-40 - Master Patient List v2 05-Feb-2016

HARE-40 - Lab Manual Manchester V12 Jan-2022

HARE-40 - LabManual Liverpool and Southampton V12 Jan-2022

HARE-40 - Intra-dose escalation form v4 12-Apr-2018

HARE-40 - Arm 1A Cohort 2 Patient Registration Form v6 01-Mar-2022

HARE-40 - Arm 1B Patient Registration Form v8 28-Feb-2022

HARE-40 Training Log v1

HARE-40 Sample Log ARM 1B v1 10Jul2020

HARE-40 Sample Log ARM 1A v1 10Jul2020

HARE-40 Screening and Registration Process Map v2

 

Database

HARE-40 - eCRF completion guidelines v7 17-Mar-2022

 

IMP Documents

HARE-40 - Pharmacy Manual v8

HARE-40 - IACT_IMPD_v11_11-Apr-2022

HARE-40 - IACT_IMPD_Appendix_l_v4_04-Oct-2021

 

Safety

HARE-40 - Additional Info and FU Form_V06_12-Sept-2022

HARE-40 - Pregnancy Reporting Form_V06_12-Sept-2022

HARE-40 - Serious Adverse Event Form_V07_12-Sept-2022

 

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