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

Published in print October 2008 | ISBN: 9780199543458
Published online May 2011 | e-ISBN: 9780191740060 | DOI: https://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.  3135 words.  Illustrated.

Subjects: Medical Oncology

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