NCT03519464Active, not recruitingPhase 2
Immunogenicity of the 9-Valent Human Papillomavirus Recombinant Vaccine in People With Idiopathic CD4 T Cell Lymphocytopenia
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
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 54 (actual)
- First submitted
- 8 May 2018
- Start date
- 4 Feb 2019
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- NCT number
- NCT03519464
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 54
- From 4 Feb 2019 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior receipt of GARDASIL 9 (Receipt of 2-valent and 4-valent versions of vaccine is not exclusionary).
- History of hypersensitivity, including severe reactions to yeast or other component of the vaccine or to a previous vaccination with another GARDASIL vaccine.
- Current use of systemic glucocorticosteroids or immunomodulants, other than corticosteroid nasal spray or inhaler and topical steroids, which are not exclusionary.
- Any cancer diagnosis or autoimmune condition requiring systemic chemotherapy or immunomodulant affecting antibody responses (i.e., rituximab, ibrutinib etc.), intravenous or subcutaneous immunoglobulin supplementation, radiation therapy, or immunomodulatory treatment within the previous 6 months (presence of precancerous lesions is not exclusionary
- Receipt of an investigational vaccine within 2 weeks of day 0.
Other illness
- HIV infection or any other recognized congenital or acquired immunodeficiency (i.e., SCID IL-2/JAK3/ADA, MAGT1, MHC1 deficiency, DOCK8, etc).
- Current moderate or severe acute illness (i.e., febrile illness, seizure, myocardial infarction, cerebrovascular accident, pulmonary embolism) that in the opinion of the PI, would make the subject unsuitable for the study.
- Any condition that, in the opinion of the investigator, contraindicates participation in this study.
Lab values
- Serum creatinine \> 1.5 times upper limit of normal, platelets \< 100,0000/mm3, hemoglobin \< 9 g/dL, or AST/ALT \> 2 times upper limit of normal, immunoglobulin G level \< 450 mg/liter.
Other
- Pregnancy or breastfeeding.
- Receipt of ACIP recommended immunizations within 1 week of day 0.
Criteria the registry did not label
- INCLUSION CRITERIA:
- Aged 18 to 70 years.
- Able to provide informed consent.
- Female study participants who engage in sexual activities that can result in pregnancy must agree to use one of the contraceptive methods listed below at every potentially reproductive sexual encounter, beginning at the baseline visit and continuing until 3 months after discontinuation of the study agent. Acceptable methods are as follows:
- Male or female condom with spermicide.
- Hormonal (e.g., consistent use of oral contraceptive pill daily or other hormonal method such as contraceptive implant or injection). Hormonal methods must be started 1 month prior to receiving the first dose of study agent.
- Diaphragm or cervical cap.
- Intrauterine device (IUD).
- 4\. Must meet criteria for 1 of the 2 study groups, as follows:
- Patients with ICL must have:
- documented ICL, defined as CD4 cell count \< 300 cells/microL in at least 2 different measurements 6 weeks apart, at any point in the past; and
- CD4 cell count \< 300 cells/microL (within 90 days prior to day 0, outside labs will be accepted).
- If patient has documented ICL as defined in i. and is currently enrolled in NIH ICL natural history protocol (EPIC 09-I-0102) a CD4 cell count \< 300 cells/ L (within 18 months of day 0) is sufficient for enrollment.
- Healthy volunteers must have:
- CD4 cell count of greater than or equal to 450 cells/MicroL (within 90 days prior to day 0, outside labs will be accepted).
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.