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NCT03519464 · ClinicalTrials.gov registry record · Phase 2
Immunogenicity of the 9-Valent Human Papillomavirus Recombinant Vaccine in People With Idiopathic CD4 T Cell Lymphocytopenia
A Phase 2 study of Idiopathic CD4 T Cell Lymphocytopenia, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT03519464 is a Phase 2 study of Idiopathic CD4 T Cell Lymphocytopenia that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 54 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03519464, a Phase 2 study of Idiopathic CD4 T Cell Lymphocytopenia, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- BIOLOGICAL Gardasil 9
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2019-02-04 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03519464
The ClinicalTrials.gov registry entry for NCT03519464 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Idiopathic CD4 T Cell Lymphocytopenia appearing as the primary indexed condition, and to 1 intervention - of which Gardasil 9 is the first listed.
NCT03519464 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT03519464 about?
NCT03519464 is a clinical study titled "Immunogenicity of the 9-Valent Human Papillomavirus Recombinant Vaccine in People With Idiopathic CD4 T Cell Lymphocytopenia". 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. Resear...
What is the current status of trial NCT03519464?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2019-02-04. Estimated completion is 2026-12-31.
What conditions does trial NCT03519464 study?
This clinical trial studies the following conditions: Idiopathic CD4 T Cell Lymphocytopenia.
What interventions are being tested in trial NCT03519464?
The interventions under investigation include: Gardasil 9 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03519464?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03519464 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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