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OpenTrials
Completed

NCT Number: NCT02624375

Immune Response to Shingles Vaccination

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

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Washington Virology Research Clinic

Seattle, Washington, 98104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

  • Has an acute or chronic medical condition that, in the opinion of the investigator, would render biopsies unsafe
  • History of coagulopathy or taking medication that may cause bleeding (long term aspirin, heparin, coumadin)
  • History of keloid formation or excessive scarring
  • History of frequent cellulitis or boils (>3 episodes in past 2 years) requiring antibiotic therapy.
  • Allergy to lidocaine, silver nitrate, or mupirocin.

Treatment and study plan

Zoster Vaccine Live

Drug

Other names: ZOSTAVAX

Primary outcomes

  1. Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Blood

    Time frame: 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

    Time frame: 4 weeks

    To determine if shingles disease boosts the local level of VZV-specific T cells in skin 4 weeks after Zostavax

Secondary outcomes

  1. Number of Participants With Adverse Events Due to Zostavax

    Time frame: 6 months

    To measure the occurrence of adverse events after Zostavax.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 8, 2015
Registry last updated
Dec 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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