Chapter category: Vaccines
Safety and Immunogenicity of HPV16 E7/Algammulin
Vaccines for Human Papilloviruses Infection and Anogenital Disease
Edited by: Robert W. TindleISBN: 1-57059-589-5
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Chapter authors:
Ian H. Frazer, Robert W. Tindle, Germain J.P. Fernando, Karen Malcolm, Karen Herd, Sue McFadyn, Peter D. Cooper and Bruce Ward
T E6 and E7, are together sufficient to immortalize human keratinocytes in vitro,1,2 and the open reading frames encoding these viral proteins are preserved in HPV-associated cervical cancers.3,4 Humoral immune responses to the E7 protein of HPV16 have been observed in 20-50% of patients with cervical cancer,5-8 confirming that the E7 protein is expressed and can be seen by the immune system. Immunity to E7 protein, induced by Immunization of experimental animals, is able to prevent the growth of transplantable tumors engineered to express HPV16 E7 protein,9-12 suggesting that an appropriate immune response, induced to E7 protein by Immunization, might similarly control HPV-associated cervical tumors in man. We therefore conducted a phase I/II clinical study of a vaccine based on recombinant HPV16 E7 protein, to establish whether this protein is immunogenic and non-toxic in man, and to estimate a minimal immunogenic dose of E7 protein for future vaccine studies. Because the safety of many live vectors has yet to be established in man, a single protein vaccine based on Algammulin, a mixture of gamma inulin and “AlhydrogelTM”, was chosen for this study.
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