Principal Investigator:
Anna Wald, MD, MPH

Study Title:
Clonal analysis of B cell repertoires following Gardasil vaccination or HPV infection

Study Description:
Human papillomavirus, or HPV, is a common sexually transmitted infection. There are more than 40 types of HPV that can cause genital infection. Most people with HPV do not even know they are infected and do not develop any symptoms. However, in some people HPV can cause genital warts or cervical cancer. The types of HPV that cause genital warts are not the same types that cause cervical cancer. It is not clear why some people get genital warts or cervical cancer and why some do not. There is no blood test to check to see if you have HPV.

Gardasil is an FDA‐approved HPV vaccine. Gardasil protects against the types of HPV that most commonly cause cervical cancer and genital warts. Gardasil is given in three doses (shots) over a 6‐month period, at 0, 2 months, and 6 months.

The purpose of this study is to learn more about the immune response to HPV that is created by the Gardasil vaccine. To do this, we will enroll women into different study groups. The study will involve between 2‐10 visits and may last up to 2 years. Visits will include blood draws and may include vaccination with the Gardasil vaccine. The first visit will last about an hour. Each follow‐up visit will last from 15‐30 minutes.

Eligibility Criteria:
Healthy women who meet all of the following criteria are eligible for inclusion in this study.

• Sexually Naïve Study Groups:
  • 18‐26 years of age
  • No history of sexual intercourse
• HPV‐Exposed Study Groups:
  • 27‐45 years of age
  • Have had ≥5 sexual partners

Exclusions (conditions which would prevent a volunteer from participating in this study):

• Are pregnant or breast‐feeding, or could become pregnant during the course of this study
• Have an immune disorder
• Allergic to yeast
• Previous vaccination against HPV, for example with Cervarix or Gardasil

Location:
University of Washington Virology Research Clinic, 908 Jefferson St, 11th floor, Seattle, WA

Compensation:
$75 ‐ $450 depending on study group