Vaccination with an HPV therapeutic vaccine (TA-CIN) in patients with HPV16 associated cervical cancer yields robust immunologic responses: Differential effects by vaccination site

Therapeutic vaccines against human papillomavirus (HPV), the necessary causative agent of cervical cancer, have the potential to stimulate HPV-specific antitumor immunity. TA-CIN, a single fusion protein comprised of HPV16 L2, E7, and E6 proteins linked in tandem, induces HPV16 E6/E7-specific T-cell mediated immune responses and L2-specific neutralizing antibodies in mice. Administration of TA-CIN following chemotherapy improved tumor control and survival in a preclinical model compared to vaccination or chemotherapy alone, suggesting it may improve outcomes for cervical cancer patients. Preclinical studies showed that therapeutic HPV vaccination in a limb proximal to the tumor improved outcomes compared to vaccination in a distal limb. This randomized, two-center study was designed to assess the safety/feasibility of administering TA-CIN to patients (pts) with HPV16-associated cervical cancer after completion of definitive primary therapy and to select the site of vaccination (arm vs thigh, i.e., distal vs proximal limb to the tumor site) for future placebo-controlled studies to assess outcomes.