NCT03519464|Active Not RecruitingPhase 2FDA Drug

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

National Institute of Allergy and Infectious Diseases (NIAID)ClinicalTrials.gov

Compare

Other study identifiers

Sponsor study identifier

180092

Secondary identifiers

18-I-0092

Study Type

interventional

Actual enrollment (reported)

Locations

1 country

Sites

Timeline

Study Start

February 4, 2019

Actual (reported)

Primary Completion

December 31, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

December 31, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: active not recruiting
Actual enrollment (reported): 54 participants
Study completion date: December 31, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
May 8, 2018
Actual (reported)
First Posted
May 9, 2018
Actual (reported)
Study Start
February 4, 2019
Actual (reported)
Primary Completion
December 31, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: October 29, 2026
Status Verified: March 10, 2026
Last Update Submitted: October 28, 2026

Conditions

Idiopathic CD4 T Cell Lymphocytopenia

Keywords

Gardasil 9SeroconversionHumoral immune responseCellular Immune ResponseMucosal Lesions

Outcome Measures

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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).
\. 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).

You may not qualify if:

Pregnancy or breastfeeding.
History of hypersensitivity, including severe reactions to yeast or other component of the vaccine or to a previous vaccination with another GARDASIL vaccine.
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.
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.

Contact the study team to confirm eligibility.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

ICL and Healthy Volunteers

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

ICL and Healthy Volunteers

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations