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HARE-40: HPV Anti-CD40 RNA vaccinE

NCT03418480 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-02-07

No results posted yet for this study

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, cervical and other) using a single cohort to establish a safe, tolerable and recommended dose of HPV vaccine.

Conditions

  • Human Papilloma Virus Related Carcinoma
  • Head and Neck Neoplasm
  • Cervical Neoplasm
  • Penile Neoplasms Malignant
  • Unknown Primary Tumors

Interventions

DRUG

BNT113

Intradermal vaccine

Sponsors & Collaborators

  • BioNTech SE

    collaborator INDUSTRY

  • University of Southampton

    lead OTHER

Principal Investigators

  • Christian Ottensmeier, Prof · University of Liverpool

  • Ioannis Karydis, Dr · University Hospitals Southampton NHS Foundation Trust

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-11
Primary Completion
2023-11-01
Completion
2024-01-24

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03418480 on ClinicalTrials.gov