Persistence of Varicella Immunity in Hospital Employees Receiving Varicella Vaccine

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by University of Colorado, Denver
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT02026089
First received: December 23, 2013
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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. ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: December 2014 (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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT02026089

Contacts
Contact: Nancy E Lang, RN, BSN 303/724-2454 nancy.lang@ucdenver.edu

Locations
United States, Colorado
Children's Hospital Colorado Not yet recruiting
Aurora, Colorado, United States
Contact: Roberta Smith, RN, MSPH, CIC    720/777-3535    roberta.smith@childrenscolorado.org   
Sub-Investigator: Roberta L Smith, RN, MSPH, CIC         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Myron J Levin, MD University of Colorado School of Medicine
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02026089     History of Changes
Other Study ID Numbers: 13-1380
Study First Received: December 23, 2013
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
DNA Virus Infections
Herpesviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014