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HPV16 PositivePhase 1NCT00988559

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

A Phase 1 study testing DNA vaccination, Gene gun vaccine and intramuscular vaccination in people with HPV16 Positive and Cervical Intraepithelial Neoplasia (CIN 2/3), run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
DNA vaccination, Gene gun vaccine and intramuscular vaccination
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
3 sitesUnited States
Study dates
Sep 2009to Jul 2016
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Johns Hopkins Outpatient Center

    Baltimore, Maryland, 21205

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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
Being tested
DNA vaccination, Gene gun vaccine, intramuscular vaccination, intra-lesional vaccine administration, therapeutic resection of the lesion
Keywords
high grade cervical dysplasia, treatment vaccine, therapeutic, HPV, DNA vaccine, gene therapy, gene gun, pre-cancerous
Medical subject headings
Uterine Cervical Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DNA vaccinationBiological

    Also called Therapeutic vaccine

    vaccination with pNGVL4a-CRT/E7(detox)

  • Gene gun vaccineDevice

    Also called PMED administration, ND10 device

    8 micrograms (group 1) or 16 micrograms (group 2)

  • intramuscular vaccinationBiological

    Also called DNA vaccine

    1mg (group 3) or 3mg (group 4) of pNGVLra-CRT/E7(detox) administered intramuscularly

  • intra-lesional vaccine administrationBiological

    Also called Intra-lesional DNA vaccination

    1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally

  • therapeutic resection of the lesionProcedure or surgery

    Also called LEEP or cold knife conization

    at week 15, all residual lesions will be resected

  • imiquimodDrug

    imiquimod applied to the cervix by the physician

Study groups in NCT00988559
Study groupRoleWhat they receive
PMED Delivery - groups 1 and 2ExperimentalSubjects will receive pNGVL4a-CRT/E7(detox) via gene gun at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.
Receives: Biological: DNA vaccination; Device: Gene gun vaccine; Procedure: therapeutic resection of the lesion
IM injections - groups 5 and 6ExperimentalSubjects will receive pNGVL4a-CRT/E7(detox) intramuscularly at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.
Receives: Biological: DNA vaccination; Biological: intramuscular vaccination; Procedure: therapeutic resection of the lesion
Intralesional delivery - group 3 and 4ExperimentalSubjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.
Receives: Biological: DNA vaccination; Biological: intra-lesional vaccine administration; Procedure: therapeutic resection of the lesion
Intralesional delivery + imiquimod - group 7ExperimentalSubjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally and imiquimod applied to the cervix at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.
Receives: Biological: DNA vaccination; Biological: intra-lesional vaccine administration; Procedure: therapeutic resection of the lesion; Drug: imiquimod

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Related Serious Adverse Events

    Presence of intervention-related serious adverse events as defined by CTCAE

    Measured: 9 months

Secondary outcomes (1)

  1. Absence of CIN2/3 Lesion by Week 15

    Number of participants with no CIN2/3 lesion at the week 15 visit

    Measured: 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00988559
Sponsor's protocol ID
J0866
Other IDs
P50CA098252, 1R21CA128232, NA_00020850
Status last verified
Jul 2018
First submitted
1 Oct 2009
Last updated
9 Jul 2018
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DNA vaccination, Gene gun vaccine and intramuscular vaccination in people with HPV16 Positive and Cervical Intraepithelial Neoplasia (CIN 2/3), run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Related Serious Adverse Events (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00988559.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2018.

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