Persistence of Varicella Immunity in Hospital Employees Receiving Varicella Vaccine

NCT02026089 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 13-1380
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Persistence of Varicella Immunity

Outcome Measures

Primary Outcomes (1)

• Determine the proportion of employees who 5 years previously received varicella vaccine at the time of employment who no longer have varicella-specific antibody.

  VZV-specific antibody measured by a sensitive gp-ELISA method at CDC

  Outcome measure data obtained at visit 1; assessed in the aggregate 3-6 months after completion of study.

Secondary Outcomes (1)

• Determine the avidity (strength with which the vaccine induced antibody binds to the varicella antigen) of varicella-specific antibody in vaccinated employees.

  Outcome measure data obtained at visit 1; assessed in the aggregate 3-6 months after completion of study.

Other Outcomes (1)

• Determine the varicella-specific T-cell and B-cell responses in vaccinees.

  At 7 and 30 days post-vaccination

Study Arms (2)

Sero-positive for varicella at least 5 years prior

NO INTERVENTION

No treatment

Varicella vaccine

ACTIVE COMPARATOR

One dose varicella vaccine (Varivax).

Biological: Varicella vaccine

Interventions

Varicella vaccine BIOLOGICAL

Varivax 0.5ml subcutaneous injection

Also known as: Varivax

Varicella vaccine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Interventions

Chickenpox Vaccine

Intervention Hierarchy (Ancestors)

Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Myron J Levin, MD

  University of Colorado School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2013
• First Posted: January 1, 2014
• Study Start: December 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)