Abstract
TA-CIN is a vaccine that comprises the human papillomavirus (HPV) type 16 L2, E6 and E7 as a single fusion protein. In a mouse model, TA-CIN effectively prevented outgrowth of HPV16-positive tumour cells. To assess the safety and immunogenicity of TA-CIN, a dose escalating (26, 128, 533 micro g), double blind and placebo-controlled phase I study was conducted in 40 healthy volunteers. TA-CIN was administered without adjuvant by intramuscular injection on weeks 0, 4 and 8. No serious adverse events of the vaccination were reported during the study. Both IgG antibodies and proliferative responses against TA-CIN were elicited at all three doses. More importantly, T-cell immunity against the HPV16 E6 and E7 oncoproteins was detected by IFN gamma ELISPOT in 8/11 evaluable subjects vaccinated with the 533 micro g dose.
Publication types
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Clinical Trial
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Adult
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Antibodies, Viral / blood
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Capsid / immunology*
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Capsid Proteins*
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Female
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Humans
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Immunization
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Immunoglobulin G / blood
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Male
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Middle Aged
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Oncogene Proteins, Viral / immunology*
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Papillomaviridae / immunology*
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Papillomavirus E7 Proteins
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Papillomavirus Vaccines*
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Repressor Proteins*
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T-Lymphocytes / immunology*
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Vaccination
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Vaccines, Synthetic / immunology*
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Viral Vaccines / adverse effects
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Viral Vaccines / immunology*
Substances
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Antibodies, Viral
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Capsid Proteins
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E6 protein, Human papillomavirus type 16
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Immunoglobulin G
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L2 protein, Human papillomavirus type 16
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Oncogene Proteins, Viral
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Papillomavirus E7 Proteins
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Papillomavirus Vaccines
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Repressor Proteins
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Vaccines, Synthetic
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Viral Vaccines
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oncogene protein E7, Human papillomavirus type 16