Idiopathic CD4 T Cell LymphocytopeniaPhase 2NCT03519464
Immunogenicity of the 9-Valent Human Papillomavirus Recombinant Vaccine in People With Idiopathic CD4 T Cell Lymphocytopenia
A Phase 2 study testing Gardasil 9 in people with Idiopathic CD4 T Cell Lymphocytopenia, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Idiopathic CD4 T Cell Lymphocytopenia
- What is being tested?
- Gardasil 9
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2019to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- Prior receipt of GARDASIL 9 (Receipt of 2-valent and 4-valent versions of vaccine is not exclusionary).
- 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.
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- 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.
- Receipt of ACIP recommended immunizations within 1 week of day 0.
- Any condition that, in the opinion of the investigator, contraindicates participation in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
As observed in other immunocompromised individuals with selective or combined T cell deficits, the prevalence and morbidity of human papillomavirus (HPV)-related disease is increased in patients with idiopathic CD4 T cell lymphocytopenia (ICL). The high burden and aggressive clinical course of HPV-associated disease in patients with ICL requires the development of effective preventive measures in this specific population. The protection from a broader range of HPV types offered by the 9-valent vaccine is expected to be particularly beneficial in this population. This applies even to patients with a history of type-specific HPV-associated disease, as this population may remain at a higher risk of acquisition of infection with new oncogenic HPV types even with increasing age. However, the immunogenicity of vaccines and in particular HPV preventive vaccines has never been systematically studied in patients with ICL.
This will be a phase 2, open-label study to assess the immunogenicity of the U.S. Food and Drug Administration (FDA)-approved 9-valent HPV recombinant vaccine GARDASIL 9 in patients 18- through 70-years-old with ICL, irrespective of HPV serostatus, presence of HPV-associated diseases, or previous immunization with bivalent or quadrivalent HPV vaccine, as well as healthy controls matched to the ICL patient group for age and gender. The study will take place at a single site (National Institutes of Health Clinical Center, Bethesda, MD). Participants will be assessed at baseline for history and/or clinical evidence of HPV-associated disease. Those with a history of or current HPV skin or mucosal disease will undergo clinically indicated evaluation and be referred for clinical care as needed. We will administer the vaccine in a population of ICL patients ranging in age from 18 through 70 years old according to the standard 3-dose schedule approved by the FDA for individuals 9 through 45 years of age, with the second and third doses administered at least 2 months and at least 6 months, respectively, after the first dose. Follow-up visits will occur 1 and 18 months after completion of the vaccination schedule. Blood will be collected at each study visit for safety and immunogenicity testing.
- Conditions
- Idiopathic CD4 T Cell Lymphocytopenia
- Being tested
- Gardasil 9
- Keywords
- Gardasil 9, Seroconversion, Humoral immune response, Cellular Immune Response, Mucosal Lesions
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gardasil 9Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| ICL and Healthy Volunteers | Other | Biological/Vaccine Receives: Biological: Gardasil 9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 1 month (+ 1 month) after vaccination #3.
Secondary outcomes (2)
Humoral responses, expressed as geometric mean titer (GMT), will be compared between patients with ICL and healthy subjects, within the subgroup of subjects who seroconvert for any specific homologous HPV genotype.
Secondary endpoint: Humoral responses, expressed as geometric mean titer (GMT), will be compared between patients with ICL and healthy subjects, within the subgroup of subjects who seroconvert for any specific homologous HPV genotype.
Measured: 18 months after vaccination No 3.
Number of adverse events (AEs) and serious adverse events (SAEs) following administration of 9-valent HPV recombinant vaccine.
Secondary endpoint: Number of adverse events (AEs) and serious adverse events (SAEs) following administration of 9-valent HPV recombinant vaccine.
Measured: 1 month (+ 1 month) after vaccination No3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start4 Feb 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Idiopathic CD4 T Cell LymphocytopeniaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Andrea Lisco, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519464
- Sponsor's protocol ID
- 180092
- Other IDs
- 18-I-0092
- Status last verified
- 10 Mar 2026
- First submitted
- 8 May 2018
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make IPD available at this time.
Publications
Joura EA, Giuliano AR, Iversen OE, Bouchard C, Mao C, Mehlsen J, Moreira ED Jr, Ngan Y, Petersen LK, Lazcano-Ponce E, Pitisuttithum P, Restrepo JA, Stuart G, Woelber L, Yang YC, Cuzick J, Garland SM, Huh W, Kjaer SK, Bautista OM, Chan IS, Chen J, Gesser R, Moeller E, Ritter M, Vuocolo S, Luxembourg A; Broad Spectrum HPV Vaccine Study. A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women. N Engl J Med. 2015 Feb 19;372(8):711-23. doi: 10.1056/NEJMoa1405044.
PubMed 25693011Joura EA, Leodolter S, Hernandez-Avila M, Wheeler CM, Perez G, Koutsky LA, Garland SM, Harper DM, Tang GW, Ferris DG, Steben M, Jones RW, Bryan J, Taddeo FJ, Bautista OM, Esser MT, Sings HL, Nelson M, Boslego JW, Sattler C, Barr E, Paavonen J. Efficacy of a quadrivalent prophylactic human papillomavirus (types 6, 11, 16, and 18) L1 virus-like-particle vaccine against high-grade vulval and vaginal lesions: a combined analysis of three randomised clinical trials. Lancet. 2007 May 19;369(9574):1693-702. doi: 10.1016/S0140-6736(07)60777-6.
PubMed 17512854Kumar D, Unger ER, Panicker G, Medvedev P, Wilson L, Humar A. Immunogenicity of quadrivalent human papillomavirus vaccine in organ transplant recipients. Am J Transplant. 2013 Sep;13(9):2411-7. doi: 10.1111/ajt.12329. Epub 2013 Jul 9.
PubMed 23837399
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03519464
- Acronym / sponsor ID
- 180092
- Conditions
- Idiopathic CD4 T Cell Lymphocytopenia
- Keywords
- Gardasil 9, Seroconversion, Humoral immune response, Cellular Immune Response, Mucosal Lesions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As observed in other immunocompromised individuals with selective or combined T cell deficits, the prevalence and morbidity of human papillomavirus (HPV)-related disease is increased in patients with idiopathic CD4 T cell lymphocytopenia (ICL). The high burden and aggressive clinical course of HPV-associated disease in patients with ICL requires the development of effective preventive measures in this specific population. The protection from a broader range of HPV types offered by the 9-valent vaccine is expected to be particularly beneficial in this population. This applies even to patients with a history of type-specific HPV-associated disease, as this population may remain at a higher risk of acquisition of infection with new oncogenic HPV types even with increasing age. However, the immunogenicity of vaccines and in particular HPV preventive vaccines has never been systematically studied in patients with ICL.
This will be a phase 2, open-label study to assess the immunogenicity of the U.S. Food and Drug Administration (FDA)-approved 9-valent HPV recombinant vaccine GARDASIL 9 in patients 18- through 70-years-old with ICL, irrespective of HPV serostatus, presence of HPV-associated diseases, or previous immunization with bivalent or quadrivalent HPV vaccine, as well as healthy controls matched to the ICL patient group for age and gender. The study will take place at a single site (National Institutes of Health Clinical Center, Bethesda, MD). Participants will be assessed at baseline for history and/or clinical evidence of HPV-associated disease. Those with a history of or current HPV skin or mucosal disease will undergo clinically indicated evaluation and be referred for clinical care as needed. We will administer the vaccine in a population of ICL patients ranging in age from 18 through 70 years old according to the standard 3-dose schedule approved by the FDA for individuals 9 through 45 years of age, with the second and third doses administered at least 2 months and at least 6 months, respectively, after the first dose. Follow-up visits will occur 1 and 18 months after completion of the vaccination schedule. Blood will be collected at each study visit for safety and immunogenicity testing.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICL and Healthy Volunteers | Other | Biological: Gardasil 9Biological/Vaccine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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).
- Patients with ICL must have:
Key exclusion criteria (11 listed)
- Prior receipt of GARDASIL 9 (Receipt of 2-valent and 4-valent versions of vaccine is not exclusionary).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gardasil 9Gardasil 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. | Biological | ICL and Healthy Volunteers |
Primary outcome
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.
Time frame: 1 month (+ 1 month) after vaccination #3.
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.
2 secondary outcomes
Humoral responses, expressed as geometric mean titer (GMT), will be compared between patients with ICL and healthy subjects, within the subgroup of subjects who seroconvert for any specific homologous HPV genotype.
Time frame: 18 months after vaccination No 3.
Number of adverse events (AEs) and serious adverse events (SAEs) following administration of 9-valent HPV recombinant vaccine.
Time frame: 1 month (+ 1 month) after vaccination No3.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 25693011Joura EA, Giuliano AR, Iversen OE, Bouchard C, Mao C, Mehlsen J, Moreira ED Jr, Ngan Y, Petersen LK, Lazcano-Ponce E, Pitisuttithum P, Restrepo JA, Stuart G, Woelber L, Yang YC, Cuzick J, Garland SM, Huh W, Kjaer SK, Bautista OM, Chan IS, Chen J, Gesser R, Moeller E, Ritter M, Vuocolo S, Luxembourg A; Broad Spectrum HPV Vaccine Study. A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women. N Engl J Med. 2015 Feb 19;372(8):711-23. doi: 10.1056/NEJMoa1405044.
- Background: PubMed 17512854Joura EA, Leodolter S, Hernandez-Avila M, Wheeler CM, Perez G, Koutsky LA, Garland SM, Harper DM, Tang GW, Ferris DG, Steben M, Jones RW, Bryan J, Taddeo FJ, Bautista OM, Esser MT, Sings HL, Nelson M, Boslego JW, Sattler C, Barr E, Paavonen J. Efficacy of a quadrivalent prophylactic human papillomavirus (types 6, 11, 16, and 18) L1 virus-like-particle vaccine against high-grade vulval and vaginal lesions: a combined analysis of three randomised clinical trials. Lancet. 2007 May 19;369(9574):1693-702. doi: 10.1016/S0140-6736(07)60777-6.
- Background: PubMed 23837399Kumar D, Unger ER, Panicker G, Medvedev P, Wilson L, Humar A. Immunogenicity of quadrivalent human papillomavirus vaccine in organ transplant recipients. Am J Transplant. 2013 Sep;13(9):2411-7. doi: 10.1111/ajt.12329. Epub 2013 Jul 9.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. No plan to make IPD available at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Lisco, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gardasil 9 in people with Idiopathic CD4 T Cell Lymphocytopenia, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1 month (+ 1 month) after vaccination #3.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03519464, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.