MedTrace Logo

Immunogenicity of the 9-Valent Human Papillomavirus Recombinant Vaccine in People With Idiopathic CD4 T Cell Lymphocytopenia

NCT03519464 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-04-24

No results posted yet for this study

Summary

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.

Conditions

  • Idiopathic CD4 T Cell Lymphocytopenia

Interventions

BIOLOGICAL

Gardasil 9

Gardasil 9 administered as a 0.5ml intramuscular injection in the deltoid region of the upper arm or in the anterolateral area of the thigh, 3-dose regimen of injections given at month 0, month 2, and month 6.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Andrea Lisco, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-04
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03519464 on ClinicalTrials.gov