title: A Phase 1 study of a recombinant viruslike particle vaccine against human papillomavirus type 11 in healthy adult volunteers.
abstract: Viruslike particles (VLPs) produced from the L1 protein of several papillomaviruses have induced protection from infection after live challenge in animal models. In the present study, the safety and immunogenicity of a human papillomavirus (HPV)--11 L1 VLP candidate vaccine were measured in a phase 1, dose-finding trial in humans. The vaccine was well tolerated and induced high levels of both binding and neutralizing antibodies. Marked increases in lymphoproliferation to HPV--11 L1 antigens were noted after the second vaccination. In addition, lymphoproliferation was induced after vaccination in peripheral blood mononuclear cells (PBMC) stimulated with heterologous L1 VLP antigens of HPV types 6 and 16. Statistically significant increases in HPV antigen--specific interferon--gamma and interleukin-5 production were measured from PBMC culture supernatants. This candidate HPV VLP vaccine induced robust B and T cell responses, and T cell helper epitopes appear to be conserved across HPV types.
authors.affiliation: Infectious Diseases Unit, Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.
authors.forename: T G
authors.initials: TG
authors.lastname: Evans
authors.forename: W
authors.initials: W
authors.lastname: Bonnez
authors.forename: R C
authors.initials: RC
authors.lastname: Rose
authors.forename: S
authors.initials: S
authors.lastname: Koenig
authors.forename: L
authors.initials: L
authors.lastname: Demeter
authors.forename: J A
authors.initials: JA
authors.lastname: Suzich
authors.forename: D
authors.initials: D
authors.lastname: O'Brien
authors.forename: M
authors.initials: M
authors.lastname: Campbell
authors.forename: W I
authors.initials: WI
authors.lastname: White
authors.forename: J
authors.initials: J
authors.lastname: Balsley
authors.forename: R C
authors.initials: RC
authors.lastname: Reichman
mesh_terms: D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D036022:Capsid Proteins; D002478:Cells, Cultured; D005260:Female; D006801:Humans; D007371:Interferon-gamma / Q000096:biosynthesis; D015848:Interleukin-5 / Q000096:biosynthesis; D008213:Lymphocyte Activation; D008297:Male; D009856:Oncogene Proteins, Viral / Q000235:genetics* / Q000276:immunology*; D053918:Papillomavirus Vaccines; D013045:Species Specificity; D013601:T-Lymphocytes / Q000276:immunology; D019444:Vaccines, DNA / Q000009:adverse effects / Q000494:pharmacology*; D014765:Viral Vaccines / Q000009:adverse effects / Q000494:pharmacology*
chemical_list: D000914:Antibodies, Viral; D036022:Capsid Proteins; D015848:Interleukin-5; C094776:L1 protein, Human papillomavirus type 11; D009856:Oncogene Proteins, Viral; D053918:Papillomavirus Vaccines; D019444:Vaccines, DNA; D014765:Viral Vaccines; D007371:Interferon-gamma