- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01489527
Preparedness Study - HPV Vaccine
Preparedness Study: Efficacy of HPV Vaccine to Reduce HIV Infection
Moffitt Cancer Center is the Coordinating Center for this study.
The purpose of this study is to develop and test the infrastructure to conduct a future Phase III vaccine efficacy trial to assess trial feasibility, and to assess human papillomavirus (HPV) genotype distribution, data needed to design a Phase III trial. The investigators propose to conduct a Preparedness study among women ages 16-24 years of age residing in a region of South Africa with a high human immunodeficiency (HIV) incidence and prevalence.
The specific aims of this study are to:
- Identify, recruit, enroll, and randomize a cohort of HIV negative women (200 per arm, 400 total) ages 16-24 years to an HPV vaccine against 4 types (HPV 6, 11, 16, 18 [Gardasil]) or placebo vaccine.
- Determine the cervical HPV prevalence and type distribution at enrollment, and cervical lesion prevalence among young females ages 16-24 years at high risk for HIV infection.
- Assess the rate of compliance through the 3-dose vaccination series
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Parow, South Africa, 7505
- Stellenbosch University
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Florida
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Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women ages 16-24 years of age residing in a region of South Africa with a high HIV incidence and prevalence
- HIV negative
- has ever had vaginal intercourse
- has never had Papanicolaou smear (Pap) testing or has only had normal Pap test results
- fully understands study procedures, risks involved in the study, and voluntarily agrees to participate by giving written informed consent
- agrees to refrain from douching/vaginal cleansing and using vaginal medications or preparations for 2 calendar days prior to the Day 1 visit as well as other future visits that include collection of cervical specimens
- agrees to refrain from sexual intercourse for 2 calendar days prior to the Day 1 visit as well as other future visits that include collection of cervical specimens
- agrees to utilize effective contraception during sexual intercourse (excluding the rhythm method, withdrawal alone, and emergency contraception) during the vaccination period.
- Informed consent procedures for females <18 years of age: Informed consent and informed assent will be obtained from parents/legal guardians and adolescents respectively, prior to participation. The consent form will include information about the study and individual request for consent of participants to participate in the study. It will be emphasized that participation is voluntary and that participants are free to withdraw from the study at any stage without any disadvantage to them. An assessment of understanding will be conducted at screening to ensure that consent is informed.
Exclusion Criteria:
- have a history of severe allergic reaction
- have a known allergy to any vaccine component (e.g., aluminum, yeast, or BENZONASE)
- are currently immuno-compromised
- have received a marketed HPV vaccine, or are pregnant and lactating
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Gardasil Vaccine Administration
Gardasil Vaccine Administration.
Family Health International (FHI) statisticians randomly assigned each participant an allocation number and then subsequently assigned a unique vial identification number for the vial of vaccine the participant should receive at each visit.
A single participant could not be assigned more than 1 allocation number.
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The study vaccine was blindly administered as supplied on Day 1, Month 2, and Month 6.
All vaccines were injected intramuscularly into the deltoid muscle by a member of the clinical staff.
Other Names:
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Placebo Comparator: Placebo Administration
Placebo Administration.
Family Health International (FHI) statisticians randomly assigned each participant an allocation number and then subsequently assigned a unique vial identification number for the vial of vaccine the participant should receive at each visit.
A single participant could not be assigned more than 1 allocation number.
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The study vaccine was blindly administered as supplied on Day 1, Month 2, and Month 6.
All vaccines were injected intramuscularly into the deltoid muscle by a member of the clinical staff.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Human Papillomavirus (HPV) Rate
Time Frame: At Enrollment - 5 Month Enrollment Period
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HPV type distribution and prevalence of each HPV type at enrollment.
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At Enrollment - 5 Month Enrollment Period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Study Compliance Rate
Time Frame: 18 Months
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Percentage of participants to complete the 3-dose vaccination series and all 4 study visits.
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18 Months
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Percentage of Participants Who Were Seropositive by HPV Type
Time Frame: At Enrollment - 5 Month Enrollment Period
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Percentage of participants who were seropositive to HPV at enrollment, by specific HPV type.
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At Enrollment - 5 Month Enrollment Period
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Percentage of Participants Seroconverted to HPV Types 6, 11, 16, or 18
Time Frame: 18 Months
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Percentage of participants who seroconverted to HPV types 6, 11, 16, or 18, following receipt of 3 doses of qHPV vaccine.
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18 Months
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Percentage of Participants Who Seroconverted to HPV Types 31, 33, 45, or 58
Time Frame: 18 Months
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The percent of women that seroconverted among those receiving qHPV vaccine compared to placebo vaccine recipients for HPV types 31, 33, 45, and 58, HPV types not directly targeted by the qHPV vaccine.
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18 Months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Anna Giuliano, Ph.D., H. Lee Moffitt Cancer Center and Research Institute
Publications and helpful links
General Publications
- Menezes LJ, Pokharel U, Sudenga SL, Botha MH, Zeier M, Abrahamsen ME, Glashoff RH, Engelbrecht S, Schim van der Loeff MF, van der Laan LE, Kipping S, Taylor D, Giuliano AR. Patterns of prevalent HPV and STI co-infections and associated factors among HIV-negative young Western Cape, South African women: the EVRI trial. Sex Transm Infect. 2018 Feb;94(1):55-61. doi: 10.1136/sextrans-2016-053046. Epub 2017 May 10.
- Sudenga SL, Torres BN, Botha MH, Zeier M, Abrahamsen ME, Glashoff RH, Engelbrecht S, Schim Van der Loeff MF, Van der Laan LE, Kipping S, Taylor D, Giuliano AR. HPV SEROSTATUS PRE- AND POST-VACCINATION IN A RANDOMIZED PHASE II PREPAREDNESS TRIAL AMONG YOUNG WESTERN CAPE, SOUTH AFRICAN WOMEN: THE EVRI TRIAL. Papillomavirus Res. 2017 Jun;3:50-56. doi: 10.1016/j.pvr.2017.02.001. Epub 2017 Feb 16.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-16685
- IISP ID 39582 (Other Grant/Funding Number: Merck)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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