Enhancement of human papillomavirus (HPV) type 16 E6 and E7-specific T-cell immunity in healthy volunteers through vaccination with TA-CIN,an HPV16 L2E7E6 fusion protein vaccine |
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Authors: | de Jong A O'Neill T Khan A Y Kwappenberg K M C Chisholm S E Whittle N R Dobson J A Jack L C St Clair Roberts J A Offringa R van der Burg S H Hickling J K |
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Institution: | Department of Immunohematology and Blood Transfusion, Leiden University Medical Centre, PO Box 9600, 2300 RC, Leiden, The Netherlands. |
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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. |
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