Chapter

Prophylactic HPV vaccines: pre-clinical and proof of principle studies

Margaret A Stanley

in Vaccines for the Prevention of Cervical Cancer

Published on behalf of Oxford University Press

ISBN: 9780199543458
Published online May 2011 | e-ISBN: 9780199607181 | DOI: http://dx.doi.org/10.1093/med/9780199543458.003.0007

Series: Oxford Oncology Library

Prophylactic HPV vaccines: pre-clinical and proof of principle studies

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• Studies of natural papilloma virus infections in the dog, rabbit, and cow showed serum induction of antibody responses to viral capsid proteins. Sero-positive animals were protected for life against challenge with high virus inocula. • Neutralizing serum antibody responses are directed against the L1 capsid protein. These responses depended on L1 in the native configuration, that is, correctly folded. • It was shown that the major capsid protein L1 of HPV 16, either with L2 or alone, when expressed via eukaryotic recombinant expression vectors self-assembled into empty protein shells or virus-like particles (VLPs); these were morphologically and antigenically comparable to wild-type papilloma virus virions. • Rabbits, cows, and dogs immunized with the relevant species-specific VLPs were protected against high-dose viral challenge. • Proof of principle phase I trials in human subjects showed HPV 16, 11, 6, and 18 VLPs were well tolerated and highly immunogenic, generating HPV L1 type-specific antibody responses at least 100-fold higher than those observed in natural infections with these genital HPV types. • A proof of principle phase II trial of a monovalent HPV 16 L1 VLP vaccine in HPV 16 naïve women 16–23 years of age demonstrated 100% efficacy against persistent HPV 16 infection and 100% against HPV 16 associated CIN.

Chapter.  3148 words.  Illustrated.

Subjects: Medical Oncology

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