Clinical trial investigates vaccine to treat recurrent respiratory papillomatosis after surgery

HPV-16 E5 Oncoprotein

HPV-16 E5 oncoprotein
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Adults with recurrent respiratory papillomatosis (RRP) who have had at least two surgeries to reduce lesions in the last 12 months may be eligible to participate in a new clinical trial at the NIH Clinical Center.

Scott M. Norberg, D.O., Assistant Research Physician in the Genitourinary Malignancies Branch, is leading a study of PRGN-2012, an experimental therapeutic vaccine for adults with RRP. RRP is a rare disorder caused by human papillomavirus (HPV). People with RRP develop small, wart-like growths (papillomas) in the upper and lower airways and lungs that can obstruct breathing and lead to respiratory complications. There is no systemic treatment for RRP. Patients require repeated surgeries to remove lesions as they grow back and spread. PRGN-2012 is an experimental therapeutic vaccine designed to create a response by the body’s immune system that will send T cells directly to cells infected with HPV. Investigators want to see if treating patients with PRGN-2012 after surgery for RRP will decrease the recurrence of lesions and thus reduce the number of complex surgeries that patients must undergo.

Clinicaltrials.gov identifier: NCT04724980

NCI Protocol ID: NCI-21-C-0013

Official Title: A Phase I Study of Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis

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Summary Posted: Wed, 03/24/2021