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

NCT00925288 | Completed Phase 4 Results DMC

• 2 other identifiers: Merck IISP 35706IRB00001625
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Human Papillomavirus Infection

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months

Secondary Outcomes (2)

• Prevalence of Infection With HPV Subtypes (6,11,16,18) Among Female Sex Workers

  Baseline

• Identify Barriers to Acceptance of HPV Vaccine Among Female Sex Workers

  Month 0

Study Arms (2)

Regular schedule

ACTIVE COMPARATOR

Duration: Gardasil HPV vaccine administered intramuscularly at 0,2,6 months

Biological: Gardasil

Modified Schedule

EXPERIMENTAL

Duration: Gardasil HPV vaccine administered intramuscularly at 0,3,6 months

Biological: Gardasil

Interventions

Gardasil BIOLOGICAL

Dosage Form: 0.5 ml intramuscular injection Dosage: Gardasil 0.5ml suspension Frequency: 3 doses

Also known as: Human Papillomavirus Quadrivalent Vaccine

Modified Schedule; Regular schedule

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Merck Sharp & Dohme LLC: collaborator
• NGO Via Libre: collaborator
• Universidad Peruana Cayetano Heredia: collaborator

Study Sites (1)

NGO Via Libre

Lima, Lima Province, Peru

Location

Related Publications (33)

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MeSH Terms

Conditions

Papillomavirus Infections; Virus Diseases

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Limitations and Caveats

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;

Results Point of Contact

• Title: Dr. Brandon Brown
• Organization: Johns Hopkins University

bbrown@jhsph.edu

949-266-4401

Study Officials

• Neal Halsey, MD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of International Health

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: June 22, 2009
• Study Start: October 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 11, 2012
• Results First Posted: October 11, 2012

Record last verified: 2012-09

Locations

PE (1)