Therapeutic Vaccination for Patients With HPV16+ Cervical Intraepithelial Neoplasia (CIN2/3)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00988559
First received: October 1, 2009
Last updated: March 23, 2014
Last verified: March 2014

October 1, 2009
March 23, 2014
September 2009
September 2015   (final data collection date for primary outcome measure)
To evaluate feasibility and toxicity in women with CIN2/3 caused by HPV16 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00988559 on ClinicalTrials.gov Archive Site
To compare immunogenicity of three different routes of administration: intradermal (ID), intramuscular (IM), and intralesional (IL) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Therapeutic Vaccination for Patients With HPV16+ Cervical Intraepithelial Neoplasia (CIN2/3)
A Pilot Study of pnGVL4a-CRT/E7 (Detox) for the Treatment of Patients With HPV16+ Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)

This study will test the efficacy and safety of different routes of administration of a DNA vaccine in patients with HPV16+ CIN2/3. Subjects will be enrolled in one of six treatment groups. Subjects enrolled in the first two groups will receive vaccination intradermally with a needle-free delivery device. Subjects enrolled in groups 3 and 4 will receive vaccination intramuscularly. Subjects enrolled in groups 5 and 6 will receive vaccine intralesionally.

Primary Objectives

  • To evaluate the feasibility and toxicity of vaccination in women with CIN2/3 caused by HPV16
  • To evaluate the effect of vaccination on histology
  • To compare immunogenicity of three different routes of administration: intradermal (ID), intramuscular (IM), intralesional (IL).

Secondary Objectives:

  • To evaluate changes in HPV viral load
  • To evaluate the cellular immune response to vaccination
  • To evaluate the humoral immune response to vaccination
  • To evaluate local tissue immune response
  • To correlate measures of immune response with clinical response
  • To correlate measures of immune response with those observed in the preclinical model
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HPV16+
  • Cervical Intraepithelial Neoplasia (CIN 2/3)
  • Biological: DNA vaccination
    vaccination with pNGVL4a-CRT/E7(detox)
    Other Name: Therapeutic vaccine
  • Device: Gene gun vaccine
    8 micrograms (group 1) or 16 micrograms (group 2)
    Other Names:
    • PMED administration
    • ND10 device
  • Biological: intramuscular vaccination
    1mg (group 3) or 3mg (group 4) of pNGVLra-CRT/E7(detox) administered intramuscularly
    Other Name: DNA vaccine
  • Biological: intra-lesional vaccine administration
    1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally
    Other Name: Intra-lesional DNA vaccination
  • Procedure: therapeutic resection of the lesion
    at week 15, all residual lesions will be resected
    Other Name: LEEP or cold knife conization
  • Experimental: PMED Delivery - groups 1 and 2
    Subjects will receive pNGVL4a-CRT/E7(detox) via gene gun at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.
    Interventions:
    • Biological: DNA vaccination
    • Device: Gene gun vaccine
    • Procedure: therapeutic resection of the lesion
  • Experimental: IM injections - groups 5 and 6
    Subjects will receive pNGVL4a-CRT/E7(detox) intramuscularly at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.
    Interventions:
    • Biological: DNA vaccination
    • Biological: intramuscular vaccination
    • Procedure: therapeutic resection of the lesion
  • Experimental: Intralesional delivery - group 3 and 4
    Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.
    Interventions:
    • Biological: DNA vaccination
    • Biological: intra-lesional vaccine administration
    • Procedure: therapeutic resection of the lesion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
39
December 2015
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients with high grade cervical intraepithelial lesions (CIN2/3)
  • patients whose lesions are HPV16+
  • patients who are age 18 or older
  • patients who are able to give informed consent
  • patients who are immunocompetent
  • patients who are not pregnant, committed to using adequate contraception if of childbearing age
  • patients who have a minimum hemoglobin level of 9

Exclusion Criteria:

  • Patients with cytologic evidence of glandular dysplasia
  • Patients with cytologic evidence of adenocarcinoma in situ
  • Patients who are pregnant
  • Patients with an active autoimmune disease
  • Patients who are taking immunosuppressive medication
  • Patients with concurrent malignancy except for nonmelanoma skin lesions
  • Patients who have an allergy to gold.
  • Patients with any evidence of damaged skin, or moles, scars, tattoos or marks at the proposed site(s) of administration that might interfere with the interpretation of local skin reactions.
  • History or evidence of a physician-diagnosed chronic or recurrent inflammatory skin disease (e.g. psoriasis, eczema, atopic dermatitis, hypersensitivity) at the proposed site of administration in the past 5 years.
  • Patients who have an active autoimmune disease or history of autoimmune disease requiring medical treatment with systemic immunosuppressants, including: inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemic, or immune thrombocytopenia, rheumatoid arthritis, SLE, and Sjogren's syndrome, sarcoidosis. Asthma or COPD that does not require systemic corticosteroids or routine use of inhaled steroids is acceptable
  • Patients who have received prior chrysotherapy (administration of gold salts to treat rheumatoid arthritis).
  • Patients with a history of arterial or venous thrombosis
  • Patients with non-healed wounds.
  • Patients with a history of keloid formation ( ID delivery group only)
  • Patients with a history of hepatitis B with persistent infection.
Female
18 Years and older
No
Contact: Clinical Trials Office Sidney Kimmel Comprehensive Cancer Center 410-955-8804 jhcccro@jhmi.edu
United States
 
NCT00988559
J0866, NA_00020850, P50CA098252, 1R21CA128232
Yes
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
Principal Investigator: Cornelia L Trimble, MD Johns Hopkins University
Sidney Kimmel Comprehensive Cancer Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP