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Brief Title: INO-3107 With Electroporation (EP) in Participants With HPV-6- and/or HPV-11-Associated Recurrent Respiratory Papillomatosis (RRP)
Official Title: An Open-label Multi-center Study of INO-3107 With Electroporation (EP) in Subjects With HPV-6- and/or HPV-11-associated Recurrent Respiratory Papillomatosis (RRP)
Study ID: NCT04398433
Brief Summary: This is a Phase 1/2 open-label, multicenter trial to evaluate the safety, tolerability, immunogenicity, and efficacy of INO-3107 in subjects with HPV-6 and/or HPV-11-associated recurrent respiratory papillomatosis (RRP). The trial population will include participants who have been diagnosed with either Juvenile-Onset RRP (J-O RRP) as defined by age at first diagnosis \<12 years or with Adult- Onset RRP (A-O RRP) as defined by age at first diagnosis ≥12 years. A safety run-in will be performed with up to six participants with a one week waiting period between each enrolled participant.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic Arizona, Phoenix, Arizona, United States
University of California at Davis, Sacramento, California, United States
Winship at Emory University Hospital Midtown, Atlanta, Georgia, United States
Johns Hopkins University School of Medicine, Baltimore, Maryland, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
NYU Langone Voice Center, New York, New York, United States
UNC School of Medicine, Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital, Cincinnati, Ohio, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
UT Southwestern Medical Center, Dallas, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
Name: Jeffrey Skolnik, MD
Affiliation: Inovio Pharmaceuticals
Role: STUDY_DIRECTOR