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

NCT03519464 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 18009218-I-0092
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic CD4 T Cell Lymphocytopenia

Keywords

Gardasil 9; Seroconversion; Humoral immune response; Cellular Immune Response; Mucosal Lesions

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  18 months after vaccination No 3.

• Number of adverse events (AEs) and serious adverse events (SAEs) following administration of 9-valent HPV recombinant vaccine.

  1 month (+ 1 month) after vaccination No3.

Study Arms (1)

ICL and Healthy Volunteers

OTHER

Biological/Vaccine

Biological: Gardasil 9

Interventions

Gardasil 9 BIOLOGICAL

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.

ICL and Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.
• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 25693011 BACKGROUND

• Joura 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.

  PMID: 17512854 BACKGROUND

• Kumar 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.

  PMID: 23837399 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

HIV Seropositivity

Interventions

Human Papillomavirus Recombinant Vaccine nonavalent

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Andrea Lisco, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: May 9, 2018
• Study Start: February 4, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-03-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)