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The University of Southampton
Southampton Clinical Trials Unit



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


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


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

Closed to recruitment


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:

Kathrin Eichhorst

Contact information

For patient referrals to Southampton Investigator Site please contact


SAE Reporting:


Fax: +49 (0) 231 700 118 68


Essential Trial Documents

HARE-40 - Protocol_V13_01-Sep-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, V11 01-Sep-2022

HARE-40 - Arm 1B Informed Consent Form, V13 01-Sep-2022

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

HARE-40 - Arm 1A Patient Information Sheet, V11 01-Sep-2022

HARE-40 - Arm 1B Patient Information Sheet, V13 01-Sep-2022

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

HARE-40 - Arm 1B Patient Screening Log v2 11-Jan-2023

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, v5 07-Jul-2022

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

HARE-40 - Arm 1B Patient Registration Form v9 16-Feb-2023

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

HARE-40 - Arm 1A Informed Consent Form Stage 1, V1 01-Sep-2022

HARE-40 - Arm 1B Informed Consent Form Stage 1, V1 01-Sep-2022

HARE-40 - Phase I Pregnancy ICF, V1 01-Sep-2022

HARE-40 - Phase I Pregnancy Information Sheet, V1 01-Sep-2022



HARE-40 - eCRF completion guidelines v8 17-Apr-2023


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



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

HARE-40 - Follow Up Form_V07_13-Feb-2023

HARE-40 - SAE form_V08_13-Feb-2023

HARE-40 - Pregnancy Reporting Form_V07_13-Feb-2023


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