Immune Response to Shingles Vaccination

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT02624375
• Collaborator: Merck Sharp & Dohme LLC (Industry)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 45
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to learn more about the immune response to varicella zoster virus (VZV).

Condition or Disease	Intervention/Treatment	Phase
Shingles	Drug: Zoster Vaccine Live	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Immune Response to Shingles Vaccination
• Actual Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Nov 1, 2019
• Actual Study Completion Date: Nov 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 10 persons over 70 years of age that received Zostavax 10 persons over 70 years of age that received Zostavax (single 0.65-mL dose subcutaneously in the deltoid region of the upper arm)	Drug: Zoster Vaccine Live; Other Names: ZOSTAVAX

Outcome Measures

Primary Outcome Measures

1. 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

2. 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 Outcome Measures

1. Number of Participants With Adverse Events Due to Zostavax [6 months]

   To measure the occurrence of adverse events after Zostavax.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Washington Virology Research Clinic	Seattle	Washington	United States	98104

Sponsors and Collaborators

• University of Washington
• Merck Sharp & Dohme LLC

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 16, 2015

More Information

Publications

None provided.

• Responsible Party: Christine Johnston, Associate Professor, University of Washington
• ClinicalTrials.gov Identifier: NCT02624375
• Other Study ID Numbers: STUDY00001399; 53354
• First Posted: Dec 8, 2015
• Last Update Posted: Dec 5, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Herpes Zoster

Study Results

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.

Arm/Group Title	Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live)
Arm/Group Description	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.
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live)
Arm/Group Description	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.
Overall Participants	10
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	74.5
Sex: Female, Male (Count of Participants)
Female	7 70%
Male	3 30%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	10 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 10%
White	9 90%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%
no history of shingles or shingles vaccination (Count of Participants)
Count of Participants [Participants]	10 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Blood
Description	To determine if Zostavax, when given as FDA indicated, boosts VZV-specific T-cells in the blood
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

10 persons 70 and older who received Zostavax

Arm/Group Title	Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live)
Arm/Group Description	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.
Measure Participants	10
Median (Inter-Quartile Range) [percentage of CD4 T cells]	0.02

2. Primary Outcome

Title	Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Skin
Description	To determine if shingles disease boosts the local level of VZV-specific T cells in skin 4 weeks after Zostavax
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live)
Arm/Group Description	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.
Measure Participants	10
Median (Inter-Quartile Range) [Percentage of CD4 T cells]	0

3. Secondary Outcome

Title	Number of Participants With Adverse Events Due to Zostavax
Description	To measure the occurrence of adverse events after Zostavax.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live)
Arm/Group Description	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.
Measure Participants	10
Count of Participants [Participants]	0 0%

Adverse Events

Time Frame	6 months
Arm/Group Title	Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live)
Arm/Group Description	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.
All Cause Mortality
	Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live)
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live)
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live)
	Affected / at Risk (%)	# Events
Total	0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.