Health TrialsbyHealthPanel

Study of Treatment for HPV16+ ASC-US or LSIL

ConditionsASC-USLSIL
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age19+
SponsorUniversity of Alabama at Birmingham

About this trial

Phase I clinical trial to assess safety of pNGVL4aCRTE6E7L2 DNA and TA-CIN protein vaccinations, and to seek the appropriate dose of the pNGVL4aCRTE6E7L2 DNA vaccine

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with persistent (>6 month period) ASC-US/LSIL determined by cervical cytology at study entry (ThinPrep with imaging)

Patients whose cytologic samples are persistent (>6 month period) HPV16+ by Roche Cobas 4800, Roche Linear Array HPV Genotyping test or other FDA-approved HPV genotyping test at study entry. Co-infections with HPV types other than HPV16 are permissible for study entry.

Age ≥ 19 years

Baseline Eastern Cooperative Oncology Group

Disqualifiers

Patients with ASC-US/LSIL determined by cervical cytology at study entry that are HPV16 negative.

Histologic evidence of CIN2+

Patients with a diagnosis of immunosuppression or prolonged, active use of immunosuppressive medications such as steroids.

Prior vaccination with any HPV antigen (prophylactic or therapeutic).

Trial design

Design model

Sequential

Treatments tested in this trial

  • pNGVL4aCRTE6E7L2

    Biological/Vaccine

    Naked pNGVL4aCRTE6E7L2 DNA plasmid

  • TA-CIN

    Biological/Vaccine

    TA-CIN is a single fusion protein comprised of HPV16 L2, E7 and E6 proteins linked in tandem.

Treatment groups

30 Participants
are divided into 4 treatment groups
Group A: pNGVL4aCRTE6E7L2 0.3mg doseExperimental treatment 1 intervention
Group B: pNGVL4aCRTE6E7L2 1 mg doseExperimental treatment 1 intervention
Group C: pNGVL4aCRTE6E7L2 3 mg doseExperimental treatment 1 intervention
Group D: PVX-6Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Safety and feasibility of pNGVL4aCRTE6E7L2 DNA vaccination

To determine the safety and feasibility of intra-muscular administration of pNGVL4aCRTE6E7L2 DNA vaccine in patients with persistent HPV16+ ASC-US/LSIL

Time frame
12 months
2

Dose finding

To determine the appropriate intra-muscular injection dose of pNGVL4aCRTE6E7L2 DNA vaccine as determined by toxicity and immunogenicity for a subsequent phase II clinical trial

Time frame
12 months
3

Safety and feasibility of PVX-6 vaccination

To determine the safety and feasibility of intra-muscular administration of pNGVL4aCRTE6E7L2 DNA vaccine prime, TA-CIN protein vaccine boost in patients with persistent HPV16+ ASC-US/LSIL

Time frame
12 months

Secondary outcomes

1

HPV16 antibody response

To evaluate the levels of circulating antibody specific for HPV-16 in the peripheral blood pre- and post-vaccination

Time frame
12 months
2

HPV16 CD8 T cell response

To evaluate the levels of circulating HPV-16 E6- and E7-specific CD8+ T cells and T regulatory cells in the peripheral blood pre- and post-vaccination

Time frame
12 months
3

HPV16 L2E7E6 T cell proliferative response

To evaluate the proliferative responses of peripheral blood mononucleocytes pre- and post-vaccination in response to stimulation by HPV16 E6, E7 and L2

Time frame
12 months
4

Clearance of HPV16

To evaluate the presence of high risk HPV, and specifically HPV16 in cytologic specimens pre- and post-vaccination

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Johns Hopkins University

Collaborator

Source ClinicalTrials.gov
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