AzTrials
AzTrials

Hematopoietic Stem Cell TransplantNCT01581164

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

An observational study of Hematopoietic Stem Cell Transplant, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 5 to 70 years
Conditions the study is for
Hematopoietic Stem Cell Transplant
What is being tested?
Influenza vaccine and Varicella vaccine
How many people
12 participants
Where
1 siteUnited States
Study dates
Dec 2011to Dec 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients who have been treated with HSCT

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California, San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

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.

Read the detailed description

Hematopoietic stem cell transplantation therapy is potentially curative for many malignant and non-malignant hematopoietic disorders. Disease recurrence and infection remain major causes of morbidity and mortality following HSCT. While innate immunity (myeloid and NK cell) is restored relatively quickly following HSCT, a prolonged period of lymphopenia occurs in all patients. This delay in lymphoid reconstitution is exacerbated with age and results in severely dampened adaptive immune responses. In children who have received chemotherapy and HSCT, T cell function generally recovers within 6 to twelve months. In contrast, lymphoid deficiency in adults may require years, and often never recovers to pre-transplant levels. Much of the delay in lymphocyte recovery is thought to be due to decreased thymic T cell production and export and the resulting expansion of treatment resistant T cell clones. Peripheral expansion of T cells in a lymphopenic setting leads to a narrowing of the TCR repertoire and manifests as a decrease in the magnitude of response to new antigens.

These long-lasting T cell deficiencies have been shown to play a direct role in post-transplant complications. There are many studies that correlate decreased T cell number and function (specifically CD4+ T cells) with an increase in post-transplant infections and relapse has been shown to be inversely proportional to T cell reconstitution following both autologous and allogeneic HSCT. Furthermore, this prolonged deficit in T cell function decreases the effectiveness of vaccination against tumour antigens and infectious diseases as well as other post-transplant immunotherapeutic strategies. Following HSCT, patients lose immunological memory not only to infectious microorganisms to which they were previously exposed but also bacterial and viral vaccines given prior to the HSCT , increasing the chance of infection post-transplant. Primary immunization requires antigenic stimulation and functionally mature T cells and therefore at least partial reconstitution of the T and B cell pools is necessary before successful reimmunization can occur.

This study presents an opportunity to analyze, at a systems level, the responses to vaccination in patients who are treated with HSCT. The expected high frequency of low responders to vaccination will permit comparisons of gene expression and immune cell activation between high and low responders as measured by the rate of seroconversion and HAI titers. The evaluation of live VZV vaccination is essential for these objective as the investigators hypothesize that live vaccination will induce a more specific immune response than dead (ie: influenza) vaccination. This study may also generate novel hypotheses about the mechanistic basis for reduced responses to vaccines post HSCT.

Being tested
Influenza vaccine, Varicella vaccine
Keywords
blood, hematopoietic, stem, cell, transplant, vaccine, vaccination, recovery, immune, system

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Influenza vaccineBiological

    Also called flu vaccine

    Influenza vaccine: Injection, post transplant

  • Varicella vaccineBiological

    Also called chicken pox vaccine

    Varicella vaccine: Injection, post transplant

Study groups in NCT01581164
Study groupRoleWhat they receive
HSCT patientsPatients who have been treated with HSCT
Receives: Biological: Influenza vaccine; Biological: Varicella vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. Immune response

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

  2. Immune response

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2012 (estimated)
  2. Study startDec 2011
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01581164
Sponsor's protocol ID
UCSF Protocol No. 112526
Status last verified
May 2015
First submitted
16 Apr 2012
Last updated
8 May 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Hematopoietic Stem Cell Transplant, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline of Immune response at Day 90 post vaccination. (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2015; AzTrials last refreshed its copy on 8 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in