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Preparedness Study - HPV Vaccine

Primary Purpose

Sexual Transmission of Infection

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Gardasil Vaccine
Placebo
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexual Transmission of Infection focused on measuring Vaccine, Placebo, sexually transmitted infection (STI), HIV, Human Immunodeficiency, Gardasil, HPV, human papillomavirus

Eligibility Criteria

16 Years - 24 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • H. Lee Moffitt Cancer Center and Research Institute
  • Stellenbosch University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Gardasil Vaccine Administration

Placebo Administration

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Human Papillomavirus (HPV) Rate
HPV type distribution and prevalence of each HPV type at enrollment.

Secondary Outcome Measures

Study Compliance Rate
Percentage of participants to complete the 3-dose vaccination series and all 4 study visits.
Percentage of Participants Who Were Seropositive by HPV Type
Percentage of participants who were seropositive to HPV at enrollment, by specific HPV type.
Percentage of Participants Seroconverted to HPV Types 6, 11, 16, or 18
Percentage of participants who seroconverted to HPV types 6, 11, 16, or 18, following receipt of 3 doses of qHPV vaccine.
Percentage of Participants Who Seroconverted to HPV Types 31, 33, 45, or 58
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.

Full Information

First Posted
December 8, 2011
Last Updated
January 21, 2015
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01489527
Brief Title
Preparedness Study - HPV Vaccine
Official Title
Preparedness Study: Efficacy of HPV Vaccine to Reduce HIV Infection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
Detailed Description
The study vaccine will be blindly administered as supplied on Day 1, Month 2, and Month 6. Both HPV and placebo vaccines will be in identical bottles, and all treatment codes will be kept under lock and key. All vaccines will be injected intramuscularly into the deltoid muscle by a member of the clinical staff. Each participant will be monitored for systemic and local reactions for 30 minutes postvaccination after each study vaccination for any adverse effects, including allergic reactions. Vaccine adverse events will continue to be monitored throughout the duration of the study period. Vaccine will be shipped to a central pharmacy at Stellenbosch University and stored in a refrigerator monitored and maintained at 2-8 C prior to distribution and local storage at participating clinical centers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Transmission of Infection
Keywords
Vaccine, Placebo, sexually transmitted infection (STI), HIV, Human Immunodeficiency, Gardasil, HPV, human papillomavirus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
406 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gardasil Vaccine Administration
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Administration
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Gardasil Vaccine
Other Intervention Name(s)
Gardasil
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Human Papillomavirus (HPV) Rate
Description
HPV type distribution and prevalence of each HPV type at enrollment.
Time Frame
At Enrollment - 5 Month Enrollment Period
Secondary Outcome Measure Information:
Title
Study Compliance Rate
Description
Percentage of participants to complete the 3-dose vaccination series and all 4 study visits.
Time Frame
18 Months
Title
Percentage of Participants Who Were Seropositive by HPV Type
Description
Percentage of participants who were seropositive to HPV at enrollment, by specific HPV type.
Time Frame
At Enrollment - 5 Month Enrollment Period
Title
Percentage of Participants Seroconverted to HPV Types 6, 11, 16, or 18
Description
Percentage of participants who seroconverted to HPV types 6, 11, 16, or 18, following receipt of 3 doses of qHPV vaccine.
Time Frame
18 Months
Title
Percentage of Participants Who Seroconverted to HPV Types 31, 33, 45, or 58
Description
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.
Time Frame
18 Months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Giuliano, Ph.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Stellenbosch University
City
Parow
ZIP/Postal Code
7505
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
28490581
Citation
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.
Results Reference
derived
PubMed Identifier
28480334
Citation
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.
Results Reference
derived

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Preparedness Study - HPV Vaccine

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