First-in-Human, Randomized, Placebo-Controlled, Double-Blind Phase 1 Study to Assess in Healthy Adults the Safety and Immunogenicity of Intramuscularly Administered AAVLP-HPV Vaccine

Abstract Seeking a simple vaccine to protect against all cancer-associated human papillomaviruses (HPV), L2 residues 17-36 of both HPV16 and HPV31 displayed on the surface of an Adeno-Associated Virus-Like Particle (AAVLP-HPV) was developed. Here, a phase 1 randomized, placebo-controlled, double-blind clinical study has been conducted in 20 male and female subjects at a single dose level (20µg) without an adjuvant. AAVLP-HPV vaccine administration was safe and well tolerated. Repeat vaccination with AAVLP-HPV elicited L2-specific neutralizing antibodies of modest titer in serum. Antibodies cross-reactive with L2 of diverse HPV types were detected, but responses were weak in most vaccinees. We conclude that while AAVLP-HPV vaccination is well tolerated, an adjuvant is likely needed to consistently elicit durable and broadly neutralizing responses. One sentence summary Vaccination with AAVLP-HPV is safe and immunogenic in healthy adults. Funding The study was funded by 2A Pharma AB. MM and RBSR were funded by service contracts from 2A Pharma AB. RBSR and JA were funded by Public Health Service (grants.nih.gov) grant P50 CA098252.