Immunogenicity of the 9-Valent Human Papillomavirus Recombinant Vaccine in People With Idiopathic CD4 T Cell Lymphocytopenia
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|ClinicalTrials.gov Identifier: NCT03519464|
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : June 18, 2018
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.
To study the effects of the vaccine GARDASIL 9 in people with ICL.
Adults ages 18-60 with ICL
Healthy volunteers the same age
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.
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic CD4 T Cell Lymphocytopenia||Biological: Gardasil 9 (recombinant HPV 9-valent vaccine)||Phase 2|
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 60-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 according to the standard 3-dose schedule approved by the FDA for individuals 9 through 26 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||June 21, 2018|
|Estimated Primary Completion Date :||February 28, 2021|
|Estimated Study Completion Date :||August 31, 2023|
A 0.5-mL 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: Gardasil 9 (recombinant HPV 9-valent vaccine)
GARDASIL 9 administered as a 0.5-mL 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.
- Proportion of patients with ICL who become seropositive to at least 1homologous HPV vaccine genotype at 1 month after completion of the vaccination schedule. [ Time Frame: 1 month (+ 1 month) after vaccination #3. ]
- Number of adverse events (AEs) and serious adverse events (SAEs)following administration of 9-valent HPV recombinant vaccine. [ Time Frame: Day 0, Month 2 (+2 months), Month 6 (+ 2 months), Follow up visit #1 (1 month +1 month) after 3rd vaccination, Follow up visit #2 (18 months +/- 2 months) after 3rd vaccination. ]
- Humoral responses, expressed as geometric mean titer (GMT), will becompared between patients with ICL and healthy subjects, within the subgroup of subjects who seroconvert for any specific homologous HPV genotype. [ Time Frame: Baseline, 1 month after completion of vaccination schedule. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519464
|Contact: Megan V Anderson, R.N.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Andrea Lisco, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|