Therapeutic Treatment With Human Papillomavirus Quadrivalent Vaccine for Recurrent Respiratory Papillomatosis

NCT00829608 | Withdrawn Early Phase 1

• 1 other identifier: 1124197
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if administration of the HPV quadrivalent vaccine in patients diagnosed with RRP has a therapeutic effect on their clinical course. More specifically, does administration of the vaccine decrease the size and number of papillomas, severity of disease (i.e. hoarseness, inspiratory vs. biphasic stridor, airway obstruction) using the LCAS and time interval between required surgical debulking will be analyzed.

Conditions

Recurrent Respiratory Papillomatosis

Keywords

RRP; Recurrent Respiratory Papillomatosis; HPV vaccine; HPV

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (1)

• The secondary end points will include changes in the RRP scoring assessment, intersurgical intervals and changes in annualized surgical rates.

  12 months

Study Arms (1)

Human Papillomavirus Vaccine

EXPERIMENTAL

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.

Biological: Human Papillomavirus Vaccine

Interventions

Human Papillomavirus Vaccine BIOLOGICAL

0.5 mL of quadrivalent HPV vaccine will be given intramuscularly at three separate intervals. Dose 2 is given 2 weeks after dose 1 and dose 3 is given 4 weeks after dose 1 for a total of 3 doses over 2 months.

Also known as: Gardasil, HPV vaccine

Human Papillomavirus Vaccine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Recurrent respiratory papillomatosis

Interventions

Papillomavirus Vaccines; Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Study Officials

• Troy D Scheidt, MD

  University of Missour-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2009
• First Posted: January 27, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: June 1, 2010
• Last Updated: October 5, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)