Acceptability of Human Papillomavirus (HPV) Vaccine in Female Sex Workers (Girasol)

This study has been completed.

Sponsor:

Collaborators:

Merck

NGO Via Libre

Universidad Peruana Cayetano Heredia

Information provided by (Responsible Party):

Neal Halsey, Johns Hopkins Bloomberg School of Public Health

ClinicalTrials.gov Identifier:

NCT00925288

First received: June 3, 2009

Last updated: September 10, 2012

Last verified: September 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Human Papillomavirus Infection	Biological: Gardasil	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Acceptability and Feasibility of a Modified HPV Vaccine Schedule in Brothel Based Female Sex Workers in Peru

Resource links provided by NLM:

Drug Information available for: Human Papillomaviruses

U.S. FDA Resources

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:

Antibody Response to HPV Vaccine for HPV 6,11,16,18. [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
We measured anitbody response to HPV vaccine for HPV subtypes 6,11,16, and 18. This was compared by study arm, namely the regular and modified vaccination schedules.
Proportion of Female Sex Workers Who Complete the Three Dose (0, 2, 6 Month) HPV Schedule in a Timely Manner Compared to the Modified (0, 3, 6 Month) Schedule. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Completion of 3 doses of HPV4 vaccine was measured at 6 months for women receiving the vaccine in 0,2,6 month regimen or the modified 0,3,6 month regimen. Completion was measured as receiving dose 3 of the vaccine during the study.

Secondary Outcome Measures:

Prevalence of Infection With HPV Subtypes (6,11,16,18) Among Female Sex Workers [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Type specific prevalence of HPV6,11,16,18 among study participants, calculated using Linear Array testing.
Identify Barriers to Acceptance of HPV Vaccine Among Female Sex Workers [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
Listed doubts about the HPV vaccine. Participants were asked if they had any doubts about the vaccine prior to learning about it from the health professional. Herein we present the total number of participants who reported doubts by study arm.

Enrollment:	200
Study Start Date:	October 2009
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Regular schedule Duration: Gardasil HPV vaccine administered intramuscularly at 0,2,6 months	Biological: Gardasil Dosage Form: 0.5 ml intramuscular injection Dosage: Gardasil 0.5ml suspension Frequency: 3 doses Other Name: Human Papillomavirus Quadrivalent Vaccine
Experimental: Modified Schedule Duration: Gardasil HPV vaccine administered intramuscularly at 0,3,6 months	Biological: Gardasil Dosage Form: 0.5 ml intramuscular injection Dosage: Gardasil 0.5ml suspension Frequency: 3 doses Other Name: Human Papillomavirus Quadrivalent Vaccine

Detailed Description:

FSWs are at higher risk of HPV infection and presumably cervical cancer, and the recently available vaccine has been shown to protect against persistent infection from these types. If this study gives evidence showing the vaccine is acceptable in preventing cervical HPV infection by types 16 and 18 in this population, then the burden of cervical cancer and cancer precursors could be drastically decreased through widespread vaccination of this target group. Vaccination at the point of entry of brothel based sex work may become a requirement to lower the burden of cervical cancer among FSWs and also among all other sex partners of clients of FSWs. A modified schedule may prove beneficial for FSWs in Peru to complete the vaccine regimen.

Eligibility

Ages Eligible for Study:	18 Years to 26 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Between the age of 18 and 26 years
Registered female sex worker living in Lima
Healthy with no known immune deficiency
Willing to participate in a study of HPV vaccine including a Pap smear, three pregnancy tests, blood draws, and three vaccine administrations over 7 months
Willing to provide informed consent

Exclusion Criteria:

Currently pregnant or planning to get pregnant in the next six months
Known immune deficiency disorder
Current receipt of immunosuppressive drugs
Allergy to yeast or known contraindication to HPV vaccine
Women who have had their cervix removed
Previous HPV vaccination
Current fever over 100 degrees Fahrenheit

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925288

Locations

Peru
NGO Via Libre
Lima, Peru

Sponsors and Collaborators

Johns Hopkins Bloomberg School of Public Health

Merck

NGO Via Libre

Universidad Peruana Cayetano Heredia

Investigators

Principal Investigator:

Neal Halsey, MD

Johns Hopkins Bloomberg School of Public Health

More Information

Publications:

de Sanjosé S, Diaz M, Castellsagué X, Clifford G, Bruni L, Muñoz 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. Review.

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.

Juárez-Figueroa LA, Wheeler CM, Uribe-Salas FJ, Conde-Glez CJ, Zampilpa-Mejía LG, García-Cisneros S, Hernández-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.

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.

del Amo J, González C, Losana J, Clavo P, Muñoz L, Ballesteros J, García-Saiz A, Belza MJ, Ortiz M, Menéndez 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.

Cañadas MP, Bosch FX, Junquera ML, Ejarque M, Font R, Ordoñez E, de Sanjosé 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.

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.

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.

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. Review.

Roden R, Wu TC. How will HPV vaccines affect cervical cancer? Nat Rev Cancer. 2006 Oct;6(10):753-63. Review.

Burchell AN, Winer RL, de Sanjosé S, Franco EL. Chapter 6: Epidemiology and transmission dynamics of genital HPV infection. Vaccine. 2006 Aug 31;24 Suppl 3:S3/52-61. Epub 2006 Jun 2. Review.

Stanley M. Immune responses to human papillomavirus. Vaccine. 2006 Mar 30;24 Suppl 1:S16-22. Review.

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. Epub 2006 Jun 23. Review.

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.

Parkin DM, Bray F. Chapter 2: The burden of HPV-related cancers. Vaccine. 2006 Aug 31;24 Suppl 3:S3/11-25. Review.

Santos C, Muñoz 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.

Clifford GM, Gallus S, Herrero R, Muñoz N, Snijders PJ, Vaccarella S, Anh PT, Ferreccio C, Hieu NT, Matos E, Molano M, Rajkumar R, Ronco G, de Sanjosé 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.

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.

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.

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. Review.

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 G, 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. Epub 2006 Nov 21.

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.

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.

Núñez JT, Delgado M, Girón 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.

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.

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.

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.

Trujillo L, Muñoz 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.

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.

García PJ, Chavez S, Feringa B, Chiappe M, Li W, Jansen KU, Cárcamo 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.

Sánchez 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.

Sánchez 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.

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. Epub 2006 Apr 4.

Responsible Party:	Neal Halsey, Professor of International Health, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:	NCT00925288 History of Changes
Other Study ID Numbers:	Merck IISP 35706, IRB00001625
Study First Received:	June 3, 2009
Results First Received:	July 3, 2012
Last Updated:	September 10, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:

Female sex worker
Peru
Cervical infection
Cervical abnormality
Serum antibody
Vaccine acceptance

Alternative schedule
Viral infections
Human papillomavirus vaccine
Human papillomavirus (HPV)
non inferiority

Additional relevant MeSH terms:

Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral

Tumor Virus Infections
Neoplasms
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013

To Top