Can the HPV vaccine protect those with a weak immune system?
NCT ID NCT03519464
First seen Jun 24, 2026 · Last updated Aug 18, 2026 · Updated 5 times
Summary
This study tests whether the HPV vaccine Gardasil 9 can trigger an immune response in people with idiopathic CD4 T cell lymphocytopenia (ICL), a rare condition that weakens the immune system. About 54 adults with ICL and some healthy volunteers will receive three doses of the vaccine over six months. Researchers will measure antibody levels to see if the vaccine helps protect against HPV-related diseases.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Gardasil 9 (HPV vaccine)
- What this could lead to
- If it works, this could show that the HPV vaccine can protect people with ICL from HPV-related diseases like warts and cancers.
- What could go wrong
- This is a small, early-phase study with only 54 participants, so results may not apply to everyone. The immune system in ICL is weak, so the vaccine may not work as well as in healthy people.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
54 people
The number who actually took part.
- Started
-
Feb 2019
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: 1. Aged 18 to 70 years. 2. Able to provide informed consent. 3. 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). EXCLUSION CRITERIA: 1. Prior receipt of GARDASIL 9 (Receipt of 2-valent and 4-valent versions of vaccine is not exclusionary). 2. Pregnancy or breastfeeding. 3. History of hypersensitivity, including severe reactions to yeast or other component of the vaccine or to a previous vaccination with another GARDASIL vaccine. 4. HIV infection or any other recognized congenital or acquired immunodeficiency (i.e., SCID IL-2/JAK3/ADA, MAGT1, MHC1 deficiency, DOCK8, etc). 5. 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. 6. 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. 7. Current use of systemic glucocorticosteroids or immunomodulants, other than corticosteroid nasal spray or inhaler and topical steroids, which are not exclusionary. 8. 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 9. Receipt of an investigational vaccine within 2 weeks of day 0. 10. Receipt of ACIP recommended immunizations within 1 week of day 0. 11. Any condition that, in the opinion of the investigator, contraindicates participation in this study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Idiopathic CD4 T cell lymphocytopenia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States