Human Papillomavirus InfectionPhase 4GirasolNCT00925288

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

A Phase 4 study testing Gardasil in people with Human Papillomavirus Infection, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Peru.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 26 years, women onlyHealthy volunteers can take part
Conditions the study is for: Human Papillomavirus Infection
What is being tested?: Gardasil
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 sitePeru
Study dates: Oct 2009to Aug 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 26 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Peru1 site

NGO Via Libre
Lima, Lima Province

Other trials in Peru

About this study

Official title: Acceptability and Feasibility of a Modified HPV Vaccine Schedule in Brothel Based Female Sex Workers in Peru

Read the 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.

Conditions: Human Papillomavirus Infection
Being tested: Gardasil
Keywords: Female sex worker, Peru, Cervical infection, Cervical abnormality, Serum antibody, Vaccine acceptance, Alternative schedule, Viral infections, Human papillomavirus vaccine, Human papillomavirus (HPV), non inferiority
Medical subject headings: Papillomavirus Infections, Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GardasilBiological
Also called Human Papillomavirus Quadrivalent Vaccine
Dosage Form: 0.5 ml intramuscular injection Dosage: Gardasil 0.5ml suspension Frequency: 3 doses

Study groups in NCT00925288
Study group	Role	What they receive
Regular schedule	Active comparator	Duration: Gardasil HPV vaccine administered intramuscularly at 0,2,6 months Receives: Biological: Gardasil
Modified Schedule	Experimental	Duration: Gardasil HPV vaccine administered intramuscularly at 0,3,6 months Receives: Biological: Gardasil

What is being measured

The primary outcome is the main question the study is designed to answer.

Antibody Response to HPV Vaccine for HPV 6,11,16,18.
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.
Measured: Month 7
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.
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.
Measured: 6 months

Secondary outcomes (2)

Prevalence of Infection With HPV Subtypes (6,11,16,18) Among Female Sex Workers
Type specific prevalence of HPV6,11,16,18 among study participants, calculated using Linear Array testing.
Measured: Baseline
Identify Barriers to Acceptance of HPV Vaccine Among Female Sex Workers
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.
Measured: Month 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009Aug 2011

First posted22 Jun 2009 (estimated)
Study startOct 2009
Primary completionAug 2011
Study completionAug 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (33)Papers the sponsor has linked to this study.
Other trials for Human Papillomavirus InfectionStudies of the same condition, open and under way.
More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00925288
Sponsor's protocol ID: Merck IISP 35706
Other IDs: IRB00001625
Acronym: Girasol
Status last verified: Sep 2012
First submitted: 3 Jun 2009
Last updated: 11 Oct 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 17597569
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.
PubMed 15054172
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.
PubMed 11289192
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.
PubMed 14596772
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.
PubMed 15681729
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.
PubMed 15004111
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.
PubMed 10987448
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.
PubMed 14678594
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.
PubMed 15371283
Roden R, Wu TC. How will HPV vaccines affect cervical cancer? Nat Rev Cancer. 2006 Oct;6(10):753-63. doi: 10.1038/nrc1973.
PubMed 16990853
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.
PubMed 16950018
Stanley M. Immune responses to human papillomavirus. Vaccine. 2006 Mar 30;24 Suppl 1:S16-22. doi: 10.1016/j.vaccine.2005.09.002.
PubMed 16219398
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.
PubMed 16950017
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.
PubMed 10037103
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.
PubMed 16949997

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Human Papillomavirus Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acceptability and Feasibility of a Modified HPV Vaccine Schedule in Brothel Based Female Sex Workers in Peru
ClinicalTrials.gov ID: NCT00925288
Acronym / sponsor ID: Girasol / Merck IISP 35706
Conditions: Human Papillomavirus Infection
Keywords: Female sex worker, Peru, Cervical infection, Cervical abnormality, Serum antibody, Vaccine acceptance, Alternative schedule, Viral infections
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC, NGO Via Libre, Universidad Peruana Cayetano Heredia
Study start: Oct 2009
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 22 Jun 2009 (estimated)
Results: Posted 11 Oct 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Regular schedule	Active comparator	Biological: GardasilDuration: Gardasil HPV vaccine administered intramuscularly at 0,2,6 months
Modified Schedule	Experimental	Biological: GardasilDuration: Gardasil HPV vaccine administered intramuscularly at 0,3,6 months

Who may qualify

Ages: 18 to 26 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GardasilAlso: Human Papillomavirus Quadrivalent VaccineDosage Form: 0.5 ml intramuscular injection Dosage: Gardasil 0.5ml suspension Frequency: 3 doses	Biological	Modified Schedule, Regular schedule

Primary outcome

Antibody Response to HPV Vaccine for HPV 6,11,16,18.
Time frame: Month 7
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
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.

2 secondary outcomes

Prevalence of Infection With HPV Subtypes (6,11,16,18) Among Female Sex Workers
Time frame: Baseline
Identify Barriers to Acceptance of HPV Vaccine Among Female Sex Workers
Time frame: Month 0

Results and safety

Results posted to the registry on 11 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Regular Schedule	100	91
Modified Schedule	100	93

Primary outcome: Antibody Response to HPV Vaccine for HPV 6,11,16,18.

Time frame: Month 7. Geometric mean (95% Confidence Interval). Unit: Milli Merck Units

Measure	Regular Schedule n = 89	Modified Schedule n = 93
HPV 6	1086.49 (854.16 to 1382.0)	1054.13 (808.42 to 1374.53)
HPV11	745.06 (588.82 to 942.76)	776.84 (644.03 to 936.21)
HPV16	3235.89 (2661.93 to 3933.61)	2704.62 (2301.71 to 3178.06)
HPV18	603.39 (487.81 to 746.35)	531.66 (441.68 to 639.97)

Regular Schedule vs Modified Schedule: p >0.20, Regression, Logistic

Population analysed: All participants who returned for the final blood draw considered in the final antibody analysis. The analysis applies to antibody levels after vaccination for HPV6, HPV11, HPV16, and HPV18. This is done for each study arm, namely the regular schedule and the modified schedule.

Primary outcome: 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. Number. Unit: participants

Measure	Regular Schedule n = 100	Modified Schedule n = 100
Value	91	93

Regular Schedule vs Modified Schedule: p = 0.60, Chi-squared

Population analysed: All participants were included

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Regular Schedule	0 of 200 (0%)	0 of 200 (0%)	Not reported
Modified Schedule	0 of 200 (0%)	0 of 200 (0%)	Not reported

Limitations and caveats (from the sponsor): Small time difference between study arms (0,2,6 and 0,3,6 months); We cannot distinguish between antibodies resulting from vaccination and antibodies resulting from natural HPV infection;

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17597569de 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: PubMed 15054172Mak 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: PubMed 11289192Juarez-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: PubMed 14596772Ford 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: PubMed 15681729del 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: PubMed 15004111Canadas 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: PubMed 10987448Kjaer 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: PubMed 14678594Tideman 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: PubMed 15371283Anhang 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: PubMed 16990853Roden R, Wu TC. How will HPV vaccines affect cervical cancer? Nat Rev Cancer. 2006 Oct;6(10):753-63. doi: 10.1038/nrc1973.
Background: PubMed 16950018Burchell 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: PubMed 16219398Stanley M. Immune responses to human papillomavirus. Vaccine. 2006 Mar 30;24 Suppl 1:S16-22. doi: 10.1016/j.vaccine.2005.09.002.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Neal Halsey, MD principal investigator

Johns Hopkins Bloomberg School of Public Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Gardasil in people with Human Papillomavirus Infection, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Peru.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Antibody Response to HPV Vaccine for HPV 6,11,16,18. (time frame: Month 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00925288, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2012.