Hespecta Vaccination in HPV+ Tumors or Malignant Lesions

NCT02821494 | Completed Phase 1 DMC

• 1 other identifier: HPV16HH01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

A phase I study to establish the highest safe dose that induces HPV16 E6-specific T-cell responses, using the highly promising novel therapeutic vaccine concept named: Hespecta (HPV E Six Peptide Conjugated To Amplivant®) to induce HPV16 E6-specific T-cell responses.

Conditions

Tumors or Premalignant Lesions

Keywords

HPV; Vaccination; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Biological activity of Hespecta

  Blood samples will be drawn and used in an array of complementary immunological assays to assess the biological activity of Hespecta. Vaccine induced immunity in the different assays is defined if the response after vaccination is at least 3-fold higher than the pre-vaccination response.

  26 weeks

Secondary Outcomes (1)

• Adverse events (AE) according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  26 weeks

Study Arms (1)

Hespecta

EXPERIMENTAL

Four dose groups of Hespecta

Biological: Hespecta

Interventions

Hespecta BIOLOGICAL

A dose escalation of Amplivant® conjugated peptide

Also known as: HPV 16 E6 synthetic peptides (E6 71-95 and E6 127-158)

Hespecta

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically documented evidence of HPV16 positive (pre)malignant lesion following standard treatment
• Patient with a tumor should have no evidence of residual disease based on physical examination at the completion of curative intent therapy
• At least four weeks and less than twelve weeks after last anti-tumor treatment
• Willing and able to comply with the protocol and to provide informed consent in accordance with institutional and regulatory guidelines
• Patients must be 18 years or older.
• Patients of child-bearing potential should test negative using a serum pregnancy test and agree to utilize effective contraception during the entire treatment and follow-up period of the study (up to 2 months after the last vaccination)
• Patients must be in good general health and ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

You may not qualify if:

• Radiotherapy, chemotherapy or other potentially immunosuppressive therapy administered within 4 weeks prior to the enrolment visit
• History of an autoimmune disease or other systemic intercurrent disease that might affect the immunocompetence of the patient, or patients receiving immunosuppressive therapy, except for topical application
• History of a second malignancy except curatively treated low-stage tumors with a histology that can be differentiated from the current tumor or premalignant lesion
• Receipt of another investigational product within the previous 4 weeks or at any time during the study period.
• Receipt of prior HPV directed immunotherapy
• Hematology and biochemistry:
• Absolute Neutrophil Count (ANC) \< 1.5 x 109/L, or platelet count \< 100 x 109/L or hemoglobin \< 6 mmol/L.
• Serum (total) bilirubin \> 2 x upper normal limit (ULN);
• Aspartate Aminotransferase (ASAT) or Alanine Aminotransferase (ALAT) \> 2.5 x ULN;
• Alkaline phosphatase levels \> 2.5 x ULN;
• Serum creatinine \> ULN or calculated clearance \</= 40 mL/min/1.73 m2 for patients with serum creatinine levels above the institutional normal value
• Human immunodeficiency virus (HIV), chronic hepatitis B or C infection.
• Any condition that in the opinion of the investigator could interfere with the conduct of the study

Sponsors & Collaborators

• Leiden University: lead
• ISA Pharmaceuticals: collaborator
• Dutch Cancer Society: collaborator
• Top Institute Pharma: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

Location

Related Publications (1)

• Speetjens FM, Welters MJP, Slingerland M, van Poelgeest MIE, de Vos van Steenwijk PJ, Roozen I, Boekestijn S, Loof NM, Zom GG, Valentijn ARPM, Krebber WJ, Meeuwenoord NJ, Janssen CAH, Melief CJM, van der Marel GA, Filippov DV, van der Burg SH, Gelderblom H, Ossendorp F. Intradermal vaccination of HPV-16 E6 synthetic peptides conjugated to an optimized Toll-like receptor 2 ligand shows safety and potent T cell immunogenicity in patients with HPV-16 positive (pre-)malignant lesions. J Immunother Cancer. 2022 Oct;10(10):e005016. doi: 10.1136/jitc-2022-005016.

  PMID: 36261215 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• H. Gelderblom, Prof.dr.

  Leiden University Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: July 1, 2016
• Study Start: March 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

NL (1)