HPV Vaccine for Low Lymphocyte Count

Recruiting in Palo Alto (17 mi)

Overseen byAndrea Lisco, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?Background: Diseases related to human papillomavirus (HPV) include warts, lesions, and cancers. ICL is idiopathic CD4 T cell lymphocytopenia. People with this rare disease get more HPV-related diseases than other people do. The diseases are more severe and harder to treat in people with ICL. Researchers want to see if the vaccine GARDASIL 9 can help people with ICL. Objective: To study the effects of the vaccine GARDASIL 9 in people with ICL. Eligibility: Adults ages 18-65 with ICL Healthy volunteers the same age Design: Participants will be screened with a physical exam, medical history, and blood and pregnancy tests. Participants will have a baseline visit with: * Physical exam * Medical history * Oral rinse collection. Participants will gargle a small amount of a saline solution, then spit it into a cup. * Apheresis. Blood will be removed through a needle in an arm. A machine will separate the blood and keep some parts for research. The rest will be returned to the participant through a needle in the other arm. * Examination for HPV-related disease. Female participants will have a Pap test. Researchers will collect swabs from some participants skin or genital lesions. Participants will get 3 doses of the study vaccine over 6 months as a shot in the upper arm or thigh muscle. They will repeat the screening tests each vaccine visit. Participants will record their temperature and side effects for several days after vaccinations. Participants may have visits after vaccinations. Participants will have 2 follow-up visits in the 18 months after the last vaccine. They will repeat most of the baseline tests. ...

Eligibility Criteria

Adults aged 18-70 with idiopathic CD4 T cell lymphocytopenia (ICL) or healthy volunteers meeting specific CD4 count criteria. Participants must not be pregnant, breastfeeding, have had GARDASIL 9 before, severe allergies to vaccine components, HIV, certain acute illnesses or immunodeficiencies, recent cancer treatments or immunomodulants.

Inclusion Criteria

I agree to use birth control if there's a chance I could get pregnant.

I started hormonal treatment at least a month before the first dose of the study drug.

Healthy volunteers must have CD4 cell count of greater than or equal to 450 cells/microL within 90 days prior to day 0.

+5 more

Exclusion Criteria

Any condition that, in the opinion of the investigator, contraindicates participation in this study.

I have HIV or another type of immune system problem.

Receipt of ACIP recommended immunizations within 1 week of day 0.

+8 more

Participant Groups

The trial is testing the effectiveness of the HPV vaccine GARDASIL 9 in people with ICL compared to healthy individuals. It involves three doses over six months and follow-up visits for up to 18 months after the last dose to monitor immune response and side effects.

1Treatment groups

Experimental Treatment

Group I: ICL and Healthy VolunteersExperimental Treatment1 Intervention

Biological/Vaccine