Preparedness Study - HPV Vaccine

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01489527
First received: December 8, 2011
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

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:

  1. 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.
  2. 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.
  3. Assess the rate of compliance through the 3-dose vaccination series

Condition Intervention
Sexual Transmission of Infection
Biological: Gardasil Vaccine
Biological: Placebo Vaccine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Preparedness Study: Efficacy of HPV Vaccine to Reduce HIV Infection

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Number of Participants With Desired Effect [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
    Evaluate the efficacy of HPV vaccination, a novel intervention, in the prevention of HIV infection among women residing in South Africa, a country among those with the highest HIV incidence rates internationally.


Secondary Outcome Measures:
  • Number of Screened Women With HIV Prevalence [ Time Frame: At Enrollment - 5 Month Enrollment Period ] [ Designated as safety issue: No ]
    Determine cervical HPV prevalence, type distribution and cervical lesion prevalence among females ages 16-24 years at high risk for HIV infection in the target population. The investigators will calculate cervical HPV prevalence, type distribution, and cervical lesion prevalence at enrollment visit for all participants. Measurements will be summarized using descriptive statistics for all participants and by study group (Gardasil vs. placebo) at each time-point. Prevalence estimates and associated 95% confidence intervals will be calculated based on exact binominal distribution assumptions.

  • Compliance Rate [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
    Assess the compliance rate through the 3-dose vaccination series, and the antibody response to vaccine one month post dose 3. The compliance rate and its 95% confidence interval will be calculated for the study groups.


Enrollment: 406
Study Start Date: September 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vaccine Administration
Family Health International (FHI) statisticians will randomly assign each participant an allocation number and then subsequently assign a unique vial identification number for the vial of vaccine the participant should receive at each visit. A single participant cannot be assigned more than 1 allocation number.
Biological: Gardasil Vaccine
The study vaccine will be blindly administered as supplied on Day 1, Month 2, and Month 6. All vaccines will be injected intramuscularly into the deltoid muscle by a member of the clinical staff.
Other Name: Gardasil
Placebo Comparator: Placebo Administration
Family Health International (FHI) statisticians will randomly assign each participant an allocation number and then subsequently assign a unique vial identification number for the vial of vaccine the participant should receive at each visit. A single participant cannot be assigned more than 1 allocation number.
Biological: Placebo Vaccine
The study vaccine will be blindly administered as supplied on Day 1, Month 2, and Month 6. All vaccines will be injected intramuscularly into the deltoid muscle by a member of the clinical staff.
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   16 Years to 24 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01489527

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
South Africa
Stellenbosch University
Parow, South Africa, 7505
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Anna Giuliano, Ph.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01489527     History of Changes
Other Study ID Numbers: MCC-16685, IISP ID 39582
Study First Received: December 8, 2011
Last Updated: May 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Vaccine
Placebo
sexually transmitted infection (STI)
HIV
Human Immunodeficiency
Gardasil
HPV
human papillomavirus

ClinicalTrials.gov processed this record on July 22, 2014