Study Name
A phase 2, open-label study to assess the immunogenicity of the 9-valent human papillomavirus recombinant vaccine in patients with idiopathic CD4 T cell lymphocytopenia
Study Number
18-I-0092
Goal of Study
We are studying the effects of GARDASIL 9 vaccination in people with ICL, which stands for idiopathic CD4 T cell lymphocytopenia. People with ICL get more human papillomavirus (HPV)-related diseases than people without ICL. HPV-related diseases include skin and genital warts and a variety of genital and anal precancerous lesions and cancers. These diseases are also more severe and harder to treat in people with ICL.
The GARDASIL 9 vaccine is approved by the U.S. Food and Drug Administration for the prevention of HPV-related diseases in people who are 9 to 26 years old. It has not been assessed for safety and effectiveness in adults over 26 years old in the U.S. However, it is being used for older adults in other countries. For example, in Australia, it is approved for use in people up to 45 years of age. The vaccine works by strengthening the immune system's ability to fight HPV infections. In this study, we will give the GARDASIL 9 vaccine to people with ICL and measure their immune system response. We will also give the vaccine to people without ICL and compare the immune responses of the 2 groups. In addition, we will collect safety information as part of this study.
Study Regimen
About 65 subjects age 18-60 will take part in this study. Study procedures include physical exam, medical history, blood draws and apheresis, and oral rinse collection. Subjects will receive three GARDASIL 9 vaccinations over a six-month period. Subjects will be seen for study follow-up 18 months after their third vaccination. Volunteers will be compensated.
Eligibility Criteria
- You are age 18-60
- You have a documented history of Idiopathic CD4 Lymphocytopenia (ICL) with a t-cell count of <300 at least twice, at least six weeks apart; OR you are a healthy volunteer with no medical conditions
- You are HIV-negative
- You have a primary care provider
- You do not have any difficulty having blood drawn
- You do not have any form of cancer
- If female, you are not currently breast feeding, pregnant, or planning to get pregnant in the near future
- You agree to have genetic testing