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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: Active Phase 2 study of Idiopathic CD4 T Cell Lymphocytopenia, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Primary Endpoint: Proportion of patients with ICL who become seropositive to at least 1 homologous HPV vaccine genotype at 1 month after completion of the vaccination schedule.
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 |
What the registry record for NCT03519464 still lists
NCT03519464 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03519464's enrollment target sits among peer trials
54 1160th of 2000 higher than 830 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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