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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 (023 8120 3507)

Trial Manager:

Anna Smith (023 8120 3833)

Clinical Data Coordinator:

Stephanie Hill (023 8120 5675)

Contact information

Email: HARE-40@soton.ac.uk

Fax: 0844 774 0621

SAE Reporting:

Email: pv-biontech@pharmsoft.de  

Fax: +49 (0) 231 700 118 68

 

Essential Trial Documents

HARE-40 Protocol_v8 22-May-18.pdf

HARE-40 IB_v6.0_16-May-18.pdf

HARE-40 Arm 1A GP Letter_v3 16May18.docx

HARE-40 Arm 1B GP Letter_v3 22May2018.docx

HARE-40 Arm 1A Informed Consent Form_v6 22May18.docx

HARE-40 Arm 1B Informed Consent Form_v8 22May18.docx

HARE-40 Genetic Informed Consent Form_v3 22May18.docx

HARE-40 Arm 1A Patient Information Sheet_v6 22May18.docx

HARE-40 Arm 1B Patient Information Sheet_v8 22May18.docx

HARE-40 Genetic Patient Information Sheet_v3 22May18.docx

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

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

HARE-40 - Site Delegation Log v1.0 06-Mar-17

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

HARE-40 Central Lab Manual v8.pdf

Hare-40 - Phase I eCRF Completion Guidelines for Sites v2 Clean

HARE-40 - Intra-dose escalation form v4 12-Apr-18

HARE-40 Arm 1A Cohort 2 Patient Registration Form v3 26-Apr-19.pdf

HARE-40 Arm 1B Patient Registration Form v4 26-Apr-19.pdf

HARE-40 Website table of blood tests - Protocol v8.pdf

Database

HARE-40 - eCRF completion guidelines

IMP Documents

HARE-40 - Pharmacy Manual v5 21-Jun-17

HARE-40 - Pharmacy Manual Appendix 1 v1 14-Mar-17

HARE-40 - Pharmacy Manual Appendix 2 v1 21-Mar-17

HARE-40 - Pharmacy Manual_Appendix 3A v1 14-Mar-17_Southampton Only

HARE-40 - Pharmacy Manual Appendix 4 v1 14-Mar-17

HARE-40 - Pharmacy Manual Appendix 5 v1 14-Mar-17

HARE-40 - Pharmacy Manual Appendix 6 v1 14-Mar-17

HARE-40 - DTH Application Manual v03.pdf

HARE-40 - DTH Application Manual v01 Appendix 1

HARE-40 - DTH Application Manual v01 Appendix 2

HARE-40 - DTH Application Manual v01 Appendix 3

HARE-40 - DTH Application Manual v01 Appendix 4

Safety

HARE-40_Safety Manual for IITs_V02.pdf

HARE-40 - Safety Assessment Form for IITs V2.0

HARE-40_SAE Reporting Form for IITs_V4.pdf

HARE-40 - Additional Information and Follow-Up Form for IITs V3.0

HARE-40 - Pregnancy Reporting Form for IITs V3.0

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