Early assessment of the efficacy of a human papillomavirus type 16 L1 virus-like particle vaccine.
A post hoc analysis was performed using combined data from two Phase I tolerability/immunogenicity studies of monovalent human papillomavirus type 11 (HPV11) or HPV16 L1 virus-like particle (VLP) vaccines. The goal was to determine if the HPV16 L1 VLP vaccine protected against HPV16 infection. Vaccine or placebo was given at 0, 2 and 6 months. HPV16 infection was defined by positive polymerase chain reaction (PCR) results following vaccination. The incidence of HPV infection was observed to be 0 cases per 100 person-years at risk in the vaccine group, and 5 cases per 100 person-years at risk in the control group. These results support the institution of larger efficacy trials for HPV L1 VLP vaccines.
Brown
Darron R
DR
Department of Medicine, Indiana University School of Medicine, Emerson Hall Room 435, 545 Barnhill Drive, Indianapolis 46022, USA. darbrow@iupui.edu
Fife
Kenneth H
KH
Wheeler
Cosette M
CM
Koutsky
Laura A
LA
Lupinacci
Lisa M
LM
Railkar
Radha
R
Suhr
Gretchen
G
Barr
Eliav
E
Dicello
Anthony
A
Li
Weili
W
Smith
Judith F
JF
Tadesse
Amha
A
Jansen
Kathrin U
KU
D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000032:analysis / Q000096:biosynthesis; D017931:DNA Primers; D004306:Dose-Response Relationship, Immunologic; D023381:Endpoint Determination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D027383:Papillomaviridae / Q000276:immunology*; D030361:Papillomavirus Infections / Q000276:immunology / Q000517:prevention & control*; D053918:Papillomavirus Vaccines; D011863:Radioimmunoassay; D020133:Reverse Transcriptase Polymerase Chain Reaction; D013048:Specimen Handling; D013997:Time Factors; D019444:Vaccines, DNA / Q000009:adverse effects / Q000276:immunology; D014765:Viral Vaccines / Q000009:adverse effects / Q000276:immunology*
D000914:Antibodies, Viral; D017931:DNA Primers; D053918:Papillomavirus Vaccines; D019444:Vaccines, DNA; D014765:Viral Vaccines