drugset / Trial / NCT00925288
Acceptability of Human Papillomavirus (HPV) Vaccine in Female Sex Workers
Phase 4
Completed
200 enrolled
Johns Hopkins Bloomberg School of Public Health
Merck Sharp & Dohme LLC · collabNGO Via Libre · collabUniversidad Peruana Cayetano Heredia · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
The primary objectives of this study are to determine the acceptance and potential for the effective use of HPV vaccine in the standard and a modified schedule in female sex workers. Secondary objectives include ascertaining the prevalence of HPV types among female sex workers by age and sexual experience.
Timeline
- Start
- 2009-10
- Primary completion
- 2011-08
- Completion
- 2011-08
Publications
- Background de Sanjose S, Diaz M, Castellsague X, Clifford G, Bruni L, Munoz N, Bosch FX. Worldwide prevalence and genotype distribution of cervical human papillomavirus DNA in women with normal cytology: a meta-analysis. Lancet Infect Dis. 2007 Jul;7(7):453-9. doi: 10.1016/S1473-3099(07)70158-5.
- Background Mak R, Van Renterghem L, Cuvelier C. Cervical smears and human papillomavirus typing in sex workers. Sex Transm Infect. 2004 Apr;80(2):118-20. doi: 10.1136/sti.2002.003749.
- Background Juarez-Figueroa LA, Wheeler CM, Uribe-Salas FJ, Conde-Glez CJ, Zampilpa-Mejia LG, Garcia-Cisneros S, Hernandez-Avila M. Human papillomavirus: a highly prevalent sexually transmitted disease agent among female sex workers from Mexico City. Sex Transm Dis. 2001 Mar;28(3):125-30. doi: 10.1097/00007435-200103000-00001.
- Background Ford K, Reed BD, Wirawan DN, Muliawan P, Sutarga M, Gregoire L. The Bali STD/AIDS study: human papillomavirus infection among female sex workers. Int J STD AIDS. 2003 Oct;14(10):681-7. doi: 10.1258/095646203322387947.
- Background del Amo J, Gonzalez C, Losana J, Clavo P, Munoz L, Ballesteros J, Garcia-Saiz A, Belza MJ, Ortiz M, Menendez B, del Romero J, Bolumar F. Influence of age and geographical origin in the prevalence of high risk human papillomavirus in migrant female sex workers in Spain. Sex Transm Infect. 2005 Feb;81(1):79-84. doi: 10.1136/sti.2003.008060.
- Background Canadas MP, Bosch FX, Junquera ML, Ejarque M, Font R, Ordonez E, de Sanjose S. Concordance of prevalence of human papillomavirus DNA in anogenital and oral infections in a high-risk population. J Clin Microbiol. 2004 Mar;42(3):1330-2. doi: 10.1128/JCM.42.3.1330-1332.2004.
- Background Kjaer SK, Svare EI, Worm AM, Walboomers JM, Meijer CJ, van den Brule AJ. Human papillomavirus infection in Danish female sex workers. Decreasing prevalence with age despite continuously high sexual activity. Sex Transm Dis. 2000 Sep;27(8):438-45. doi: 10.1097/00007435-200009000-00003.
- Background Tideman RL, Thompson C, Rose B, Gilmour S, Marks C, van Beek I, Berry G, O'Connor C, Mindel A. Cervical human papillomavirus infections in commercial sex workers-risk factors and behaviours. Int J STD AIDS. 2003 Dec;14(12):840-7. doi: 10.1258/095646203322556192.
- Background Anhang R, Goodman A, Goldie SJ. HPV communication: review of existing research and recommendations for patient education. CA Cancer J Clin. 2004 Sep-Oct;54(5):248-59. doi: 10.3322/canjclin.54.5.248.
- Background Roden R, Wu TC. How will HPV vaccines affect cervical cancer? Nat Rev Cancer. 2006 Oct;6(10):753-63. doi: 10.1038/nrc1973.
- Background Burchell AN, Winer RL, de Sanjose S, Franco EL. Chapter 6: Epidemiology and transmission dynamics of genital HPV infection. Vaccine. 2006 Aug 31;24 Suppl 3:S3/52-61. doi: 10.1016/j.vaccine.2006.05.031. Epub 2006 Jun 2.
- Background Stanley M. Immune responses to human papillomavirus. Vaccine. 2006 Mar 30;24 Suppl 1:S16-22. doi: 10.1016/j.vaccine.2005.09.002.
- Background Moscicki AB, Schiffman M, Kjaer S, Villa LL. Chapter 5: Updating the natural history of HPV and anogenital cancer. Vaccine. 2006 Aug 31;24 Suppl 3:S3/42-51. doi: 10.1016/j.vaccine.2006.06.018. Epub 2006 Jun 23.
- Background Holowaty P, Miller AB, Rohan T, To T. Natural history of dysplasia of the uterine cervix. J Natl Cancer Inst. 1999 Feb 3;91(3):252-8. doi: 10.1093/jnci/91.3.252.
- Background Parkin DM, Bray F. Chapter 2: The burden of HPV-related cancers. Vaccine. 2006 Aug 31;24 Suppl 3:S3/11-25. doi: 10.1016/j.vaccine.2006.05.111.
- Background Santos C, Munoz N, Klug S, Almonte M, Guerrero I, Alvarez M, Velarde C, Galdos O, Castillo M, Walboomers J, Meijer C, Caceres E. HPV types and cofactors causing cervical cancer in Peru. Br J Cancer. 2001 Sep 28;85(7):966-71. doi: 10.1054/bjoc.2001.1948.
- Background Clifford GM, Gallus S, Herrero R, Munoz N, Snijders PJ, Vaccarella S, Anh PT, Ferreccio C, Hieu NT, Matos E, Molano M, Rajkumar R, Ronco G, de Sanjose S, Shin HR, Sukvirach S, Thomas JO, Tunsakul S, Meijer CJ, Franceschi S; IARC HPV Prevalence Surveys Study Group. Worldwide distribution of human papillomavirus types in cytologically normal women in the International Agency for Research on Cancer HPV prevalence surveys: a pooled analysis. Lancet. 2005 Sep 17-23;366(9490):991-8. doi: 10.1016/S0140-6736(05)67069-9.
- Background Jacobs MV, Walboomers JM, Snijders PJ, Voorhorst FJ, Verheijen RH, Fransen-Daalmeijer N, Meijer CJ. Distribution of 37 mucosotropic HPV types in women with cytologically normal cervical smears: the age-related patterns for high-risk and low-risk types. Int J Cancer. 2000 Jul 15;87(2):221-7.
- Background Melkert PW, Hopman E, van den Brule AJ, Risse EK, van Diest PJ, Bleker OP, Helmerhorst T, Schipper ME, Meijer CJ, Walboomers JM. Prevalence of HPV in cytomorphologically normal cervical smears, as determined by the polymerase chain reaction, is age-dependent. Int J Cancer. 1993 Apr 1;53(6):919-23. doi: 10.1002/ijc.2910530609.
- Background Kitchener HC, Castle PE, Cox JT. Chapter 7: Achievements and limitations of cervical cytology screening. Vaccine. 2006 Aug 31;24 Suppl 3:S3/63-70. doi: 10.1016/j.vaccine.2006.05.113.
- Background Villa LL, Costa RL, Petta CA, Andrade RP, Paavonen J, Iversen OE, Olsson SE, Hoye J, Steinwall M, Riis-Johannessen G, Andersson-Ellstrom A, Elfgren K, Krogh Gv, Lehtinen M, Malm C, Tamms GM, Giacoletti K, Lupinacci L, Railkar R, Taddeo FJ, Bryan J, Esser MT, Sings HL, Saah AJ, Barr E. High sustained efficacy of a prophylactic quadrivalent human papillomavirus types 6/11/16/18 L1 virus-like particle vaccine through 5 years of follow-up. Br J Cancer. 2006 Dec 4;95(11):1459-66. doi: 10.1038/sj.bjc.6603469. Epub 2006 Nov 21.
- Background FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007 May 10;356(19):1915-27. doi: 10.1056/NEJMoa061741.
- Background Halsey NA, Moulton LH, O'Donovan JC, Walcher JR, Thoms ML, Margolis HS, Krause DS. Hepatitis B vaccine administered to children and adolescents at yearly intervals. Pediatrics. 1999 Jun;103(6 Pt 1):1243-7. doi: 10.1542/peds.103.6.1243.
- Background Nunez JT, Delgado M, Giron H, Pino G. Prostitution and other cofactors in preinvasive and invasive lesions of the cervix. Aust N Z J Obstet Gynaecol. 2004 Jun;44(3):239-43. doi: 10.1111/j.1479-828X.2004.00222.x.
- Background Winer RL, Hughes JP, Feng Q, O'Reilly S, Kiviat NB, Holmes KK, Koutsky LA. Condom use and the risk of genital human papillomavirus infection in young women. N Engl J Med. 2006 Jun 22;354(25):2645-54. doi: 10.1056/NEJMoa053284.
- Background Ohshige K, Morio S, Mizushima S, Kitamura K, Tajima K, Suyama A, Usuku S, Tia P, Hor LB, Heng S, Saphonn V, Tochikubo O, Soda K. Behavioural and serological human immunodeficiency virus risk factors among female commercial sex workers in Cambodia. Int J Epidemiol. 2000 Apr;29(2):344-54. doi: 10.1093/ije/29.2.344.
- Background Miller GA, Mendoza W, Krone MR, Meza R, Caceres CF, Coates TJ, Klausner JD. Clients of female sex workers in Lima, Peru: a bridge population for sexually transmitted disease/HIV transmission? Sex Transm Dis. 2004 Jun;31(6):337-42. doi: 10.1097/00007435-200406000-00003.
- Background Trujillo L, Munoz D, Gotuzzo E, Yi A, Watts DM. Sexual practices and prevalence of HIV, HTLV-I/II, and Treponema pallidum among clandestine female sex workers in Lima, Peru. Sex Transm Dis. 1999 Feb;26(2):115-8. doi: 10.1097/00007435-199902000-00010.
- Background Paris M, Gotuzzo E, Goyzueta G, Aramburu J, Caceres CF, Castellano T, Jordan NN, Vermund SH, Hook EW 3rd. Prevalence of gonococcal and chlamydial infections in commercial sex workers in a Peruvian Amazon city. Sex Transm Dis. 1999 Feb;26(2):103-7. doi: 10.1097/00007435-199902000-00008.
- Background Garcia PJ, Chavez S, Feringa B, Chiappe M, Li W, Jansen KU, Carcamo C, Holmes KK. Reproductive tract infections in rural women from the highlands, jungle, and coastal regions of Peru. Bull World Health Organ. 2004 Jul;82(7):483-92.
- Background Sanchez J, Gotuzzo E, Escamilla J, Carrillo C, Phillips IA, Barrios C, Stamm WE, Ashley RL, Kreiss JK, Holmes KK. Gender differences in sexual practices and sexually transmitted infections among adults in Lima, Peru. Am J Public Health. 1996 Aug;86(8):1098-107. doi: 10.2105/ajph.86.8_pt_1.1098.
- Background Sanchez J, Campos PE, Courtois B, Gutierrez L, Carrillo C, Alarcon J, Gotuzzo E, Hughes J, Watts D, Hillier SL, Buchanan K, Holmes KK. Prevention of sexually transmitted diseases (STDs) in female sex workers: prospective evaluation of condom promotion and strengthened STD services. Sex Transm Dis. 2003 Apr;30(4):273-9. doi: 10.1097/00007435-200304000-00001.
- Background Barnabas RV, Laukkanen P, Koskela P, Kontula O, Lehtinen M, Garnett GP. Epidemiology of HPV 16 and cervical cancer in Finland and the potential impact of vaccination: mathematical modelling analyses. PLoS Med. 2006 May;3(5):e138. doi: 10.1371/journal.pmed.0030138. Epub 2006 Apr 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gardasil | Vaccine | 0.5 ml | Intramuscular |