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
Prangsgaard, J.; Huus, E.; Alvarez, J.; Roden, R. B.; Mueller, M.; Chen, Q.; Nyzell, P. B.; Vestergaard Nieland, J. D.
Show 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 (20 ug) 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.
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