Studies of the Immune Response to Vaccination After Hematopoietic Stem Cell Transplantation

NCT01581164 | Completed DMC

• 1 other identifier: UCSF Protocol No. 112526
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to perform a serial analysis of immune function using blood cells and sera obtained from patients after vaccination following hematopoietic stem cell transplantation (HSCT). The focus of this study will be to characterize several immune parameters during the clinical course of HSCT and correlate these findings with the effect of vaccination.

Conditions

Hematopoietic Stem Cell Transplant

Keywords

blood; hematopoietic; stem; cell; transplant; vaccine; vaccination; recovery; immune; system

Outcome Measures

Primary Outcomes (1)

• Change from baseline of Immune response at Day 90 post vaccination.

  Participants will have blood drawn at baseline to Day 90 post vaccinations following hematopoietic stem cell transplantation. Average study participation is 1-3 years post transplant.

  Participants will have blood drawn at baseline and on Days 1, 7, 10, 28, and 90 post vaccinations following hematopoietic stem cell transplantation. Average study participation is 1-3 years post transplant.

Secondary Outcomes (2)

• Immune response

  Participants will have blood drawn at 1 month intervals post hematopoietic stem cell transplantation . Average study participation is 1-3 years post transplant.

• Immune response

  Blood will drawn at baseline and Days 1, 7, 10, 28, and 90 post vaccination. Participants will receive the vaccine, 12-28 months post hematopoietic stem cell transplantation.

Study Arms (1)

HSCT patients

Patients who have been treated with HSCT

Biological: Influenza vaccine; Biological: Varicella vaccine

Interventions

Influenza vaccine BIOLOGICAL

Influenza vaccine: Injection, post transplant

Also known as: flu vaccine

HSCT patients

Varicella vaccine BIOLOGICAL

Varicella vaccine: Injection, post transplant

Also known as: chicken pox vaccine

HSCT patients

Eligibility Criteria

• Age: 5 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have been treated with HSCT

You may qualify if:

• Patients who have been treated with HSCT.
• Patients must be 5-70 years of age.
• For patients participating in Objective 3: Patients must be immunocompetent (no active GVHD and must be off all immunosuppression)

You may not qualify if:

• Patients who do not wish to participate or unable to provide the necessary blood samples required for the protocol.
• Patients with history of allergic reaction to a vaccination.
• Patient has had Guillain-Barre syndrome.
• Patients who are pregnant or become pregnant.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum will be collected and stored for immunologic analysis after vaccination. Samples will be cryopreserved. No cell lines will be created using samples procured on this protocol.

MeSH Terms

Interventions

Influenza Vaccines; Chickenpox Vaccine

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jeffrey Venstrom, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2012
• First Posted: April 20, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 8, 2015

Record last verified: 2015-05

Locations

US (1)