Antibody Production Following H1N1 Influenza Vaccination After Stem Cell and Heart Transplantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01008683
First received: November 5, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

Stem cell and and heart transplant patients will receive pandemic H1N1 influenza vaccination according to the clinical guidelines.

In these patients the investigators will measure the specific antibody production.


Condition
H1N1 Influenza

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Antibody Production Following H1N1 Influenza Vaccination After Stem Cell and Heart Transplantation

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 300
Study Start Date: November 2009
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stem cell and and heart transplant patients
Stem cell and and heart transplant patients

Detailed Description:

Stem cell and and heart transplant patients will receive pandemic H1N1 influenza vaccination according to the clinical guidelines. Two doses will be given, in 3-week interval.

In these patients we will measure the specific antibody production. Blood sample 5 ml will be drawn before the first vaccine, before the second, and 3-4 weeks after the 2nd dose.

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Stem cell and and heart transplant patients who will receive pandemic H1N1 influenza vaccination according to the clinical guidelines.

Criteria

Inclusion Criteria:

  • Stem cell and and heart transplant patients who will receive pandemic H1N1 influenza vaccination according to the clinical guidelines.

Exclusion Criteria:

  • Patients with unstable grafts.
  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: NCT01008683

Contacts
Contact: Hadas Lemberg lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: Dan Engelhard       engelhard@hadassah.org.il   
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Dan Engelhard Hadassah
  More Information

No publications provided

Responsible Party: Dan Engelhard, HMO
ClinicalTrials.gov Identifier: NCT01008683     History of Changes
Other Study ID Numbers: engelhard-HMO-CTIL
Study First Received: November 5, 2009
Last Updated: November 5, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Stem cell and and heart transplant patients who will receive pandemic H1N1 influenza vaccinations

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014