Preparedness Study - HPV Vaccine
Preparedness Study - HPV Vaccine
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.
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