A controlled trial of a human papillomavirus type 16 vaccine - PubMed (original) (raw)
Clinical Trial
. 2002 Nov 21;347(21):1645-51.
doi: 10.1056/NEJMoa020586.
Affiliations
- PMID: 12444178
- DOI: 10.1056/NEJMoa020586
Free article
Clinical Trial
A controlled trial of a human papillomavirus type 16 vaccine
Laura A Koutsky et al. N Engl J Med. 2002.
Free article
Abstract
Background: Approximately 20 percent of adults become infected with human papillomavirus type 16 (HPV-16). Although most infections are benign, some progress to anogenital cancer. A vaccine that reduces the incidence of HPV-16 infection may provide important public health benefits.
Methods: In this double-blind study, we randomly assigned 2392 young women (defined as females 16 to 23 years of age) to receive three doses of placebo or HPV-16 virus-like-particle vaccine (40 microg per dose), given at day 0, month 2, and month 6. Genital samples to test for HPV-16 DNA were obtained at enrollment, one month after the third vaccination, and every six months thereafter. Women were referred for colposcopy according to a protocol. Biopsy tissue was evaluated for cervical intraepithelial neoplasia and analyzed for HPV-16 DNA with use of the polymerase chain reaction. The primary end point was persistent HPV-16 infection, defined as the detection of HPV-16 DNA in samples obtained at two or more visits. The primary analysis was limited to women who were negative for HPV-16 DNA and HPV-16 antibodies at enrollment and HPV-16 DNA at month 7.
Results: The women were followed for a median of 17.4 months after completing the vaccination regimen. The incidence of persistent HPV-16 infection was 3.8 per 100 woman-years at risk in the placebo group and 0 per 100 woman-years at risk in the vaccine group (100 percent efficacy; 95 percent confidence interval, 90 to 100; P<0.001). All nine cases of HPV-16-related cervical intraepithelial neoplasia occurred among the placebo recipients.
Conclusions: Administration of this HPV-16 vaccine reduced the incidence of both HPV-16 infection and HPV-16-related cervical intraepithelial neoplasia. Immunizing HPV-16-negative women may eventually reduce the incidence of cervical cancer.
Copyright 2002 Massachusetts Medical Society
Comment in
- The beginning of the end for cervical cancer?
Crum CP. Crum CP. N Engl J Med. 2002 Nov 21;347(21):1703-5. doi: 10.1056/NEJMe020121. N Engl J Med. 2002. PMID: 12444186 No abstract available. - A human papillomavirus type 16 vaccine.
Duggirala MK, Cuddihy MT. Duggirala MK, et al. N Engl J Med. 2003 Apr 3;348(14):1402-5; author reply 1402-5. doi: 10.1056/NEJM200304033481418. N Engl J Med. 2003. PMID: 12672871 No abstract available. - A human papillomavirus type 16 vaccine.
Tammela JE, Lele S, Odunsi K. Tammela JE, et al. N Engl J Med. 2003 Apr 3;348(14):1402-5; author reply 1402-5. N Engl J Med. 2003. PMID: 12678018 No abstract available. - A human papillomavirus type 16 vaccine.
Gambacorti CB. Gambacorti CB. N Engl J Med. 2003 Apr 3;348(14):1402-5; author reply 1402-5. N Engl J Med. 2003. PMID: 12678022 No abstract available. - A human papillomavirus type 16 vaccine.
Yoo SS, Whitmore SE. Yoo SS, et al. N Engl J Med. 2003 Apr 3;348(14):1402-5; author reply 1402-5. N Engl J Med. 2003. PMID: 12678023 No abstract available.
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