A Controlled Trial of a Human Papillomavirus Type 16 Vaccine

• Published in: The New England journal of medicine Vol. 347; no. 21; pp. 1645 - 1651
• Main Authors: Koutsky, Laura A, Ault, Kevin A, Wheeler, Cosette M, Brown, Darron R, Barr, Eliav, Alvarez, Frances B, Chiacchierini, Lisa M, Jansen, Kathrin U
• Format: Journal Article
• Language: English
• Published: Boston, MA Massachusetts Medical Society 21.11.2002
• Subjects: Adolescent; Adult; Aluminum; Antibodies, Viral - blood; Biological and medical sciences; Cervical cancer; Cervical Intraepithelial Neoplasia - epidemiology; Cervical Intraepithelial Neoplasia - prevention & control; Cervical Intraepithelial Neoplasia - virology; DNA, Viral - analysis; Double-Blind Method; Female; Follow-Up Studies; Human papillomavirus; Human viral diseases; Humans; Infectious diseases; Medical sciences; Papillomaviridae - genetics; Papillomaviridae - immunology; Papillomaviridae - isolation & purification; Papillomavirus Infections - epidemiology; Papillomavirus Infections - prevention & control; Papillomavirus Vaccines; Tumor Virus Infections - epidemiology; Tumor Virus Infections - prevention & control; Uterine Cervical Neoplasms - epidemiology; Uterine Cervical Neoplasms - prevention & control; Uterine Cervical Neoplasms - virology; Vaccines; Viral diseases; Viral diseases of the genital and urinary system; Viral Vaccines - adverse effects; Viral Vaccines - immunology; Carcinoma; Vaccination; Papovaviridae; Uterine cervix; Incidence; Papillomavirus; Prevention; Human papillomavirus 16; Human papillomavirus; Randomization; Complication; Clinical trial; Female; Human; Age criterion; Malignant tumor; Female genital diseases; Infection; Virus; Immunoprophylaxis; Sexually transmitted disease; Viral disease; Placebo; Double blind study; Uterine cervix diseases
• ISSN: 0028-4793; 1533-4406
• DOI: 10.1056/NEJMoa020586

Human papillomavirus type 16 (HPV-16) is sexually transmitted and is present in 50 percent of cervical cancers. This randomized, double-blind trial assessed the effectiveness of a vaccine that consists of HPV-16 L1 virus-like particles in women who were seronegative for HPV-16. The vaccine was highly effective in preventing HPV-16 infection. The vaccine prevents HPV-16 infection, which is present in half of cervical cancers. Human papillomavirus (HPV) infection is a common sexually transmitted disease. 1 – 4 Although most infections are benign, persistent infection (repeated detection of an oncogenic type of HPV) is associated with the development of cervical and other anogenital cancers. 5 – 9 Of the more than 30 types of HPV known to infect human genitalia, HPV type 16 (HPV-16) is most commonly linked with cancer, since it is present in 50 percent of cervical cancers and high-grade cervical intraepithelial neoplasias 4 , 10 , 11 and in 25 percent of low-grade cervical intraepithelial neoplasias. 11 , 12 A vaccine that prevents persistent HPV-16 infection could substantially reduce the incidence . . .