Shingles
Conditions
Brief summary
The purpose of this study is to learn more about the immune response to varicella zoster virus (VZV).
Detailed description
Participants 70 years of age or older will receive the FDA-approved shingles vaccine (Zostavax). Blood samples and optional skin biopsies will be obtained before and after vaccination to study the immune responses to shingles vaccination.
Interventions
Sponsors
Merck Sharp & Dohme LLC
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 70 years of age or older. * History of chickenpox.
Exclusion criteria
* Previous vaccination with Zostavax or with the chickenpox vaccine. * History of ever having had shingles. * Been in close contact with a person who had chickenpox or shingles in the past 5 years. * VZV seronegative * Taking systemic suppressive regular doses of drugs with anti-VZV activity such as acyclovir, famciclovir, or valacyclovir. Episodic use is allowed. For Cohort 1: medication cannot be taken 24 hours prior to or 30 days after receiving Zostavax per CDC recommendations. * HIV seropositive. * Hepatitis C infection or active Hepatitis B infection. * History of a life-threatening allergic reaction (anaphylactic/anaphylactoid reaction) to gelatin, neomycin, or any other component of shingles vaccine. Neomycin allergy manifested as contact dermatitis is not an exclusion. * 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 dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed). * Women of child-bearing potential only: pregnant or planning to become pregnant 3 months post vaccination * Donated blood in the past 8 weeks or planning to donate blood during the study * Weighs less than 110 lbs * Has any condition or medical history that would, in the opinion of the site principal investigator place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol. Additional exclusions for optional skin biopsy: 1. Has an acute or chronic medical condition that, in the opinion of the investigator, would render biopsies unsafe 2. History of coagulopathy or taking medication that may cause bleeding (long term aspirin, heparin, coumadin) 3. History of keloid formation or excessive scarring 4. History of frequent cellulitis or boils (\>3 episodes in past 2 years) requiring antibiotic therapy. 5. Allergy to lidocaine, silver nitrate, or mupirocin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Blood | 6 months | To determine if Zostavax, when given as FDA indicated, boosts VZV-specific T-cells in the blood |
| Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Skin | 4 weeks | To determine if shingles disease boosts the local level of VZV-specific T cells in skin 4 weeks after Zostavax |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events Due to Zostavax | 6 months | To measure the occurrence of adverse events after Zostavax. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred from September 2016 to January 2018. Recruitment was done by placing flyers at retirement homes and by contacting persons over 70 who had previously been enrolled in research studies including giving informed written consent to be re contacted for future studies.
Participants by arm
| Arm | Count |
|---|---|
| Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live) We administered Zostavax at the FDA approved dose and route to an FDA-indication-approved population, namely healthy adults 70 and over. We administered vaccine to 10 persons as proposed in the protocol. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live) |
|---|---|
| Age, Continuous | 74.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| no history of shingles or shingles vaccination | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Blood
To determine if Zostavax, when given as FDA indicated, boosts VZV-specific T-cells in the blood
Time frame: 6 months
Population: 10 persons 70 and older who received Zostavax
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live) | Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Blood | 0.02 percentage of CD4 T cells |
Primary
Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Skin
To determine if shingles disease boosts the local level of VZV-specific T cells in skin 4 weeks after Zostavax
Time frame: 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live) | Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Skin | 0 Percentage of CD4 T cells |
Secondary
Number of Participants With Adverse Events Due to Zostavax
To measure the occurrence of adverse events after Zostavax.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live) | Number of Participants With Adverse Events Due to Zostavax | 0 Participants |