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

December 8, 2011
May 2, 2014
September 2012
June 2015   (final data collection date for primary outcome measure)
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.
Number of Participants With Desired Effect [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
Our overall goal is to 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. We hypothesize that HPV vaccination will reduce the incidence of HIV.
Complete list of historical versions of study NCT01489527 on ClinicalTrials.gov Archive Site
  • 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.
  • 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. We 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.
Not Provided
Not Provided
 
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:

  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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Sexual Transmission of Infection
  • 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
  • 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
  • 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.
    Intervention: Biological: Gardasil Vaccine
  • 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.
    Intervention: Biological: Placebo Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
406
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Female
16 Years to 24 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   South Africa
 
NCT01489527
MCC-16685, IISP ID 39582
Yes
H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
Merck Sharp & Dohme Corp.
Principal Investigator: Anna Giuliano, Ph.D. H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP