NCT02444936

ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors

A Pilot Study Using a Randomized Design to Evaluate the Immunologic Efficacy and Safety of ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Louis Stokes VA Medical Center · Federal
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates if the shingles vaccine works in those persons that receive it before they receive chemotherapy for solid organ tumors. Half of the participants will receive the ZOSTAVAX shingle vaccine and half of the participants will not received anything.

Detailed description

This study is a single blind randomized clinical trial measuring the immunologic efficacy of ZOSTAVAX vs. no vaccine in 60 adults with solid organ tumors before, during and after chemotherapy. The personnel performing the laboratory studies will be blinded to vaccine vs. no vaccine. In a pilot study of an FDA approved vaccine that is being used within the parameters of the package insert and ACIP recommendations, placebo vaccine is not required to access our key primary immunologic endpoint.

Conditions

• Shingles

Interventions

Type	Name	Description
DRUG	ZOSTAVAX	Shingles vaccine

Timeline

• Start date: 2015-05-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2015-05-15
• Last updated: 2018-04-06
• Results posted: 2018-04-06