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Investigator Initiated Study of Effects of Progression of Recurrent Respiratory Papillomatosis in Patients After They Are Given Human Papillomavirus Quadrivalent Vaccine


Phase 0
18 Years
80 Years
Not Enrolling
Both
Recurrent Respiratory Papillomatosis

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Trial Information

Investigator Initiated Study of Effects of Progression of Recurrent Respiratory Papillomatosis in Patients After They Are Given Human Papillomavirus Quadrivalent Vaccine


Patients who carry the diagnosis of Recurrent Respiratory Papillomatosis (RRP) will be asked
to participate in the study. These patients have been followed by the faculty investigator
for several years. Their disease state requires frequent interventions aimed at decreasing
the severity and symptomatology of their vocal fold papillomas. Patients will be given the
human papillomavirus quadrivalent vaccine and their clinical course will be followed over
the next 6 months. Patients will have a laryngoscopic examination prior to treatment to
establish their baseline disease state. They will have repeat laryngoscopic examinations at
the time of the first, second and third vaccine injections, which will be given 1 month
intervals for a total of 3 doses. They will have physical exam and laryngoscopic
examinations at 1 month intervals for the first 6 months after administration of the
vaccine. The severity of their clinical disease will be objectively measured using a
validated scale for RRP assessment, the Laryngoscopic and Clinical Assessment Scale (LCAS).


Inclusion Criteria:



- There are 9 participants currently being followed in the faculty sponsor's clinic
that carry the clinical and histologic diagnosis of RRP. The 9 participants meet one
or more of the following criteria: Surgery requirement of more than 4 procedures per
year, distal multisite spread of disease, and rapid regrowth of papilloma disease
with airway compromise.

Exclusion Criteria:

- If any of the 9 patients meet the following criteria they will be excluded from the
study:

- Pregnancy

- Hypersensitivity or allergy to vaccine components (i.e. Saccharomyces cerevisiae
yeast)

- Immunocompromised patients (i.e. patients with HIV, cancer, or who take
immunosuppressant medications including all forms of steroids)

- Have a fever over 100°F (37.8°C)

- Moderate or severe acute illness (with or without fever)

- Coagulopathies

- Platelet counts of less than 100,000

- Any history of recent treatment(within 3 months) with any investigational drug
or other adjuvant RRP therapy (including interferon-gamma, ribavirin, acyclovir,
cidofovir and photodynamic therapy, indole-3-carbinol)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Comparison of the pre-vaccine and post-vaccine RRP scoring assessments, intersurgical intervals, and annualized surgical rates.

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Troy D Scheidt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Missour-Columbia

Authority:

United States: Institutional Review Board

Study ID:

1124197

NCT ID:

NCT00829608

Start Date:

January 2009

Completion Date:

June 2010

Related Keywords:

  • Recurrent Respiratory Papillomatosis
  • RRP
  • Recurrent Respiratory Papillomatosis
  • HPV vaccine
  • HPV
  • Papilloma
  • Respiratory Tract Infections
  • Papillomavirus Infections

Name

Location
University of Missouri Columbia, Missouri  65212