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HPV Anti-CD40 RNA Vaccine (HARE-40)

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ClinicalTrials.gov Identifier: NCT03418480
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : May 24, 2022
BioNTech SE
Information provided by (Responsible Party):
University of Southampton

Brief Summary:

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: BNT113 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : July 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arm Intervention/treatment
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: BNT113
Intradermal vaccine

Experimental: RAN Vaccine B
Arm 1B: 29 (15+14) patients with HPV16+ advanced disease receiving increasing doses of HPV vaccine.
Drug: BNT113
Intradermal vaccine

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Arm 1A:

  • Previous HPV16+ head and neck squamous cell carcinoma.
  • At least 12 months after completion of treatment.
  • Within 5 years of treatment completion.
  • Currently no clinical evidence of disease.
  • ECOG performance status 0 or 1.

Arm 1B:

  • HPV16+ head and neck, cervical, anogenital and penile carcinoma patients with recurrent disease.
  • Intention to treat is palliative.
  • Patient willing to have repeated tumour biopsies and re-biopsy deemed safe and feasible clinically.
  • Tissue samples available confirming HPV16+ disease to send to Central Laboratory.

Exclusion Criteria:

  • Patients unable to consent.
  • Any patient who has been previously vaccinated in any Arm of the trial.
  • <18 years
  • Systemic steroids (prednisolone >10 mg/day or equivalent) or other drugs with a likely effect on immune competence are forbidden during the trial. The predictable need of their use will preclude the patient from trial entry. Replacement steroids for adrenal insufficiency/failure are allowed.
  • Major surgery in the preceding three to four weeks, which the patient has not yet recovered from.
  • Patients who are of high medical risk because of non-malignant systemic disease, as well as those with active uncontrolled infection.
  • Patients with clinically relevant autoimmune disease will be excluded.
  • Patients who are known to be allergic to any of the excipients or constituents of the vaccine
  • Patients with any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial, such as concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease.
  • Current malignancies at other sites, with the exception of adequately treated basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for five years and are deemed at low risk for recurrence, are eligible for the study.
  • Patients who are serologically positive for or are known to suffer from Hepatitis B, C, Syphilis or HIV. Counselling will be offered to all patients prior to testing.
  • Patients who have a positive pregnancy test or who are breast feeding.
  • Fertile males or females who are unable or unwilling to use an effective method of birth control (eg. condom with spermicide, diaphragm with spermicide, birth control pills, injections, patches, intrauterine device, or intrauterine hormone-releasing system) during study treatment and until 28 days after patients finish the study treatment.
  • Elevated Liver Function Tests - ALT >3.0 x ULN, AST >3.0 x ULN, Bilirubin >3.0 x ULN.
  • Any other investigational drug within 28 days or 5 half-lives depending on what gives the longer range before the first treatment of this study

Information from the National Library of Medicine

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

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Contact: Phase One Clinic phaseoneclinic@soton.ac.uk

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United Kingdom
Univeristy Hospitals Southampton NHS Foundation Trust Recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact: Phase I Research Nurses    023 8120 5113    phaseoneclinic@soton.ac.uk   
Principal Investigator: Ioannis Karydis, Dr         
Sponsors and Collaborators
University of Southampton
BioNTech SE
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Principal Investigator: Christian Ottensmeier, Prof University of Liverpool
Principal Investigator: Ioannis Karydis, Dr University Hospitals Southampton NHS Foundation Trust
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Responsible Party: University of Southampton
ClinicalTrials.gov Identifier: NCT03418480    
Other Study ID Numbers: RHMCAN0983
2014-002061-30 ( EudraCT Number )
ISRCTN51789191 ( Other Identifier: ISRCTN Reference No. )
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Carcinoma, Squamous Cell
Uterine Cervical Neoplasms
Penile Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Neoplasms, Male
Penile Diseases