The DOI matches its Crossref record; 16 of the 16 references it cites were found in a registry or an index.
Efficacy of Human Papillomavirus-16 Vaccine to Prevent Cervical Intraepithelial Neoplasia: A Randomized Controlled Trial
Abstract
OBJECTIVE: Human papillomavirus (HPV) virus-like particle (VLP) vaccines have demonstrated effectiveness in preventing persistent HPV infections. Whether protection lasts longer than 18 months and, thus, impacts rates of cervical intraepithelial neoplasia (CIN) 2-3 has not yet been established. We present results from an HPV16 L1 VLP vaccine trial through 48 months. METHODS: A total of 2,391 women, aged 16-23 years, participated in a randomized, double-blind, placebo-controlled trial. Either 40 mug HPV16 L1 VLP vaccine or placebo was given intramuscularly at day 1, month 2, and month 6. Genital samples for HPV16 DNA and Pap tests were obtained at day 1, month 7, and then 6-monthly through month 48. Colposcopy and cervical biopsies were performed if clinically indicated and at study exit. Serum HPV16 antibody titer was measured by radioimmunoassay. RESULTS: Among 750 placebo recipients in the per protocol population, 12 women developed HPV16-related CIN2-3 (6 CIN2 and 6 CIN3). Among 755 vaccine recipients, there were no cases (vaccine efficacy 100%, 95% confidence interval [CI] 65-100%). There were 111 cases of persistent HPV16 infection in placebo recipients and 7 cases in vaccine recipients (vaccine efficacy 94%, 95% CI 88-98%). After immunization, HPV16 serum antibody geometric mean titers peaked at month 7 (1,519 milli-Merck units [mMU]/mL), declined through month 18 (202 mMU/mL), and remained relatively stable between month 30 and month 48 (128-150 mMU/mL). CONCLUSION: The vaccine HPV16 L1 VLP provides high-level protection against persistent HPV16 infection and HPV16-related CIN2-3 for at least 3.5 years after immunization. Administration of L1 VLP vaccines targeting HPV16 is likely to reduce risk for cervical cancer. LEVEL OF EVIDENCE: I.
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Cites
Natural History of Cervicovaginal Papillomavirus Infection in Young Women
Ho, G. Y. F., Bierman, R., Beardsley, L., Chang, C. J., & Burk, R. D. (1998) · New England Journal of Medicine · doi:10.1056/nejm199802123380703 · Cited by 2,329
NATURAL HISTORY OF CERVICOVAGINAL PAPILLOMAVIRUS INFECTION IN YOUNG WOMEN
Loria, G. R., Ierman, R. O. B., Eardsley, L. E. B., & Hang, H. J. C. (1998) · Cited by 1,890
Harper, D. M., Franco, E. L., Wheeler, C., Ferris, D. G., Jenkins, D., Schuind, A., Zahaf, T., Innis, B., Naud, P., De Carvalho, N. S., et al. (2004) · The Lancet · doi:10.1016/s0140-6736(04)17398-4 · Cited by 1,643
Self-citationA Controlled Trial of a Human Papillomavirus Type 16 Vaccine
Koutsky, L. A., Ault, K. A., Wheeler, C. M., Brown, D. R., Barr, E., Alvarez, F. B., Chiacchierini, L. M., & Jansen, K. U. (2002) · New England Journal of Medicine · doi:10.1056/nejmoa020586 · Cited by 1,602
Self-citationVilla, L. L., Costa, R. L., Petta, C. A., Andrade, R. P., Ault, K. A., Giuliano, A. R., Wheeler, C. M., Koutsky, L. A., Malm, C., Lehtinen, M., et al. (2005) · The Lancet Oncology · doi:10.1016/s1470-2045(05)70101-7 · Cited by 1,579
Self-citationHuman papillomavirus types in invasive cervical cancer worldwide: a meta-analysis
Clifford, G. M., Smith, J. S., Plummer, M., Muñoz, N., & Franceschi, S. (2003) · British Journal of Cancer · doi:10.1038/sj.bjc.6600688 · Cited by 1,561
Clifford, G. M., Smith, J. S., Aguado, T., & Franceschi, S. (2003) · British Journal of Cancer · doi:10.1038/sj.bjc.6601024 · Cited by 684
Carter, J. J., Koutsky, L. A., Hughes, J. P., Lee, S. K., Kuypers, J., Kiviat, N., & Galloway, D. A. (2000) · The Journal of Infectious Diseases · doi:10.1086/315498 · Cited by 575
Self-citationClifford, G. M., Rana, R. K., Franceschi, S., Smith, J. S., Gough, G., & Pimenta, J. M. (2005) · Cancer Epidemiology, Biomarkers & Prevention · doi:10.1158/1055-9965.epi-04-0812 · Cited by 533
The Estimated Direct Medical Cost of Sexually Transmitted Diseases Among American Youth, 2000
Chesson, H. W., Blandford, J. M., Gift, T. L., Tao, G., & Irwin, K. L. (2004) · Perspectives on Sexual and Reproductive Health · doi:10.1363/3601104 · Cited by 444
Cited by
Arbyn, M., Xu, L., Simoens, C., & Martin-Hirsch, P. P. (2018) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd009069.pub3 · Cited by 621
Carrageenan is a potent inhibitor of papillomavirus infection
Buck, C. B., Thompson, C. D., Roberts, J. N., Müller, M., Lowy, D. R., & Schiller, J. T. (2006) · PLoS Pathogens · doi:10.1371/journal.ppat.0020069 · Cited by 497
Health and Economic Implications of HPV Vaccination in the United States
Kim, J. J., & Goldie, S. J. (2008) · New England Journal of Medicine · doi:10.1056/nejmsa0707052 · Cited by 365
Metadata
- Authors
- Mao, C., Koutsky, L. A., Ault, K. A., Wheeler, C. M., Brown, D. R., Wiley, D. J., Alvarez, F. B., Bautista, O. M., Jansen, K. U., & Barr, E.
- Venue
- Obstetrics & Gynecology
- Published
- 2006-01
- Volume
- 107
- Issue
- 1
- Pages
- 18-27
- ISSN
- 0029-7844 (ISSN-L)
- OpenAlex
- W1995350271
- Cited by
- 451
- References
- 16
- FWCI
- 61.76
- Type
- journal article
- Language
- en
- Open access
- closed
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- Mao, C., Koutsky, L. A., Ault, K. A., Wheeler, C. M., Brown, D. R., Wiley, D. J., Alvarez, F. B., Bautista, O. M., Jansen, K. U., & Barr, E. (2006). Efficacy of Human Papillomavirus-16 Vaccine to Prevent Cervical Intraepithelial Neoplasia: A Randomized Controlled Trial. Obstetrics & Gynecology. https://doi.org/10.1097/01.aog.0000192397.41191.fb
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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