VZV-specific Tissue Resident Memory T-cells After Shingrix Vaccination
United States50 participantsStarted 2022-04-27
Plain-language summary
To evaluate the effect of intramuscular RZV vaccine on VZV-specific skin TRM and circulating T-cells
Who can participate
Age range30 Years
SexALL
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Inclusion Criteria:
* Cohort 1: 30-40 years of age
* Cohort 2: 70 years of age or older
* HIV seronegative
Exclusion Criteria:
* Previous vaccination with Shingrix (RZV), Zostavax (ZVL, zoster vaccine live), or with the chickenpox vaccine
* VZV seronegative
* Active Hepatitis C infection or active Hepatitis B infection. Persons with serologic evidence of hepatitis C infection that has cleared spontaneously, or with a history of treated hepatitis C with a sustained virologic response, can be enrolled. Persons with a history of resolved hepatitis B infection (negative for hepatitis B surface antigen) can be enrolled
* History of a life-threatening allergic reaction (anaphylactic/anaphylactoid reaction) to any component of the vaccine
* History of receipt of an organ transplant or hematopoietic stem cell transplant
* Significant autoimmune disease such as rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, multiple sclerosis, scleroderma, dermatomyositis, or other condition which in the past has required significant immune modifying medication or which has a clinical course that is characterized by relapses
* Has immunosuppression as a result of an underlying illness (e.g. leukemia, lymphoma or other malignant neoplasms) or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy.
* Has long-term use of oral or parenteral steroids (\>7 days), or high-dose inhaled steroids (\>800 mcg/day of beclomethasone di…
What they're measuring
1
Level of gE-specific IgG in serum.
Timeframe: up to 1 year after vaccination
2
Level of gE-specific CD4 T cells in blood
Timeframe: up to 1 year after vaccination
3
Cytokine profile of gE-specific CD4 T cells in blood