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Persistence of Varicella Immunity in Hospital Employees Receiving Varicella Vaccine

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2016 by University of Colorado, Denver
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
University of Colorado, Denver Identifier:
First received: December 23, 2013
Last updated: December 21, 2016
Last verified: December 2016
The purpose of the study is to learn more abou how the immune system responds to the chickenpox vaccine in adults who had never had chickenpox as a child and were then vaccinated as an adult. The study aims to learn more about the strength and duration of the protection provided by the vaccine in adults, and to observe the immune response to an additional dose of chickenpox vaccine in adults who had received the vaccine at least 5 years earlier. This is especially relevant to workers in a hospital who may be exposed to chickenpox.

Condition Intervention Phase
Persistence of Varicella Immunity
Biological: Varicella vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Persistence of Varicella Immunity in Hospital Employees Receiving Varicella Vaccine

Resource links provided by NLM:

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • The proportion of employees who 5 years previously received varicella vaccine at the time of employment who no longer have varicella-specific antibody. [ Time Frame: Outcome measure data obtained at visit 1; assessed in the aggregate 3-6 months after completion of study. ]

Secondary Outcome Measures:
  • Determine the avidity (strength with which the vaccine induced antibody binds to the varicella antigen) of varicella-specific antibody in vaccinated employees. [ Time Frame: Outcome measure data obtained at visit 1; assessed in the aggregate 3-6 months after completion of study. ]
    Avidity in these employees will be compared to the avidity of antibody in employees who did hot require vaccination because of natural immunity.

Other Outcome Measures:
  • Determine the varicella-specific T-cell and B-cell responses in vaccinees. [ Time Frame: At 7 and 30 days post-vaccination ]
    Responses will be compared to those present in employees who did not require vaccination because of natural immunity.

Estimated Enrollment: 100
Study Start Date: May 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Sero-positive for varicella at least 5 years prior
No treatment
Active Comparator: Varicella vaccine
One dose varicella vaccine (Varivax).
Biological: Varicella vaccine
Other Name: Varivax


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age 18-80
  • Group 1: * Evaluated in Occupational Health Clinic (OHC) for employment from 2004-2009 and found to be seronegative for varicella.

    • Received at least one varicella vaccination to meet employment criteria at least 5 year prior to enrollment.
    • Subject is afebrile (<100.4F oral) on day of vaccination.
  • Group 2: * Evaluated in OHC for employment from 2004 -2009 and found to be seropositive for varicella.

Exclusion Criteria:

  • Immune suppressed or receiving immune suppressive treatment
  • Pregnant, breastfeeding or plan to become pregnant within 6 weeks after receiving varicella vaccine.
  • Receiving antiviral medications active against varicella virus within 3 days before varicella vaccination until 10 days after varicella vaccination.
  • Receipt of any vaccine within 2 weeks before enrollment or expected receipt within 6 weeks after vaccination.
  • Receipt of any immunoglobulins or blood products within 5 months prior to study enrollment or expected receipt prior to last visit.
  • History of hypersensitivity reaction to any vaccine component (including gelatin), or an anaphylactic/anaphylactoid reaction to neomycin.
  • History of chickenpox or shingles since pre-employment serology testing.
  • Receipt of any additional varicella or zoster vaccine since vaccination under hospital policy and procedure guidelines.
  • Currently participating in any other studies with an investigational compound within 30 days of signing the consent and throughout participation in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02026089

Contact: Nancy E Lang, RN, BSN 303/724-2454

United States, Colorado
Children's Hospital Colorado Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Amanda Kennedy, RN    720-777-3535   
Contact: Myron J Levin, MD    303-724-2451   
Sponsors and Collaborators
University of Colorado, Denver
Centers for Disease Control and Prevention
Principal Investigator: Myron J Levin, MD University of Colorado School of Medicine
  More Information

Responsible Party: University of Colorado, Denver Identifier: NCT02026089     History of Changes
Other Study ID Numbers: 13-1380 
Study First Received: December 23, 2013
Last Updated: December 21, 2016

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on February 27, 2017