title: 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.
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.
authors.affiliation: Department of Immunohematology and Blood Transfusion, Leiden University Medical Centre, PO Box 9600, 2300 RC, Leiden, The Netherlands.
authors.forename: A
authors.initials: A
authors.lastname: de Jong
authors.forename: T
authors.initials: T
authors.lastname: O'Neill
authors.forename: A Y
authors.initials: AY
authors.lastname: Khan
authors.forename: K M C
authors.initials: KM
authors.lastname: Kwappenberg
authors.forename: S E
authors.initials: SE
authors.lastname: Chisholm
authors.forename: N R
authors.initials: NR
authors.lastname: Whittle
authors.forename: J A
authors.initials: JA
authors.lastname: Dobson
authors.forename: L C
authors.initials: LC
authors.lastname: Jack
authors.forename: J A
authors.initials: JA
authors.lastname: St Clair Roberts
authors.forename: R
authors.initials: R
authors.lastname: Offringa
authors.forename: S H
authors.initials: SH
authors.lastname: van der Burg
authors.forename: J K
authors.initials: JK
authors.lastname: Hickling
mesh_terms: D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D002213:Capsid / Q000276:immunology*; D036022:Capsid Proteins; D005260:Female; D006801:Humans; D007114:Immunization; D007074:Immunoglobulin G / Q000097:blood; D008297:Male; D008875:Middle Aged; D009856:Oncogene Proteins, Viral / Q000276:immunology*; D027383:Papillomaviridae / Q000276:immunology*; D050725:Papillomavirus E7 Proteins; D053918:Papillomavirus Vaccines; D012097:Repressor Proteins; D013601:T-Lymphocytes / Q000276:immunology*; D014611:Vaccination; D014614:Vaccines, Synthetic / Q000276:immunology*; D014765:Viral Vaccines / Q000009:adverse effects / Q000276:immunology*
chemical_list: D000914:Antibodies, Viral; D036022:Capsid Proteins; C068651:E6 protein, Human papillomavirus type 16; D007074:Immunoglobulin G; C063316:L2 protein, Human papillomavirus type 16; D009856:Oncogene Proteins, Viral; D050725:Papillomavirus E7 Proteins; D053918:Papillomavirus Vaccines; D012097:Repressor Proteins; D014614:Vaccines, Synthetic; D014765:Viral Vaccines; C059731:oncogene protein E7, Human papillomavirus type 16