Immunogenicity and Safety of Inactivated H1N1 Swine-origin Influenza Monovalent Vaccine in Immunocompromised Children and Young Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01000571
First received: October 19, 2009
Last updated: October 5, 2011
Last verified: October 2011
  Purpose

This study will evaluate the immunogenicity and safety of inactivated H1N1 swine-origin monovalent influenza vaccine in immunocompromised children and young adults.


Condition
H1N1 Pandemic Flu

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Immunogenicity and Safety of Inactivated H1N1 Swine-origin Influenza Monovalent Vaccine in Immunocompromised Children and Young Adults

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • This study will document Seroprotection (a post-vaccine antibody response ≥ an HI titer of 1:40). [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • This study will document seroconversion rates (a 4-fold or greater rise in HI titer comparing pre- and post-vaccine sera). [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Blood sample collection will be done according to the description provided in the institutional policy manual. When possible, blood draws will be made through existing implanted catheters. If the research participant does not have a catheter, a peripheral venipuncture will be performed. Serum and whole blood for immune assays will be frozen at -20ºC or in liquid nitrogen until processed in batched assays.


Enrollment: 104
Study Start Date: October 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
H1N1 pandemic influenza vaccine recipient
Children and young adults between the ages of 6 months and 21 years and 13 kg or greater in body weight with underlying conditions of cancer, HIV, sickle cell disease or receipt of a stem cell transplant more than a year prior to study entry and who will receive inactivated H1N1 swine-origin monovalent influenza vaccine in the winter/fall of 2009-2010 as part of their routine clinical care.Target total accrual of up to 400 children and young adults stratified based on their underlying diagnosis as follows: 150 children or young adults with cancer, 100 with human immunodeficiency virus (HIV), 100 with sickle cell disease, and 50 with receipt of a stem cell transplant more than a year prior to study entry.

Detailed Description:

This is a prospective observational study. This study will not dictate vaccine administration, nor the vaccine product to be used. It will collect data in St Jude patients who will receive the vaccine as part of their clinical care per institutional guidelines. Research participants will receive two doses of inactivated H1N1 swine-origin monovalent influenza vaccine administered 28 days apart as part of clinical care. Each dose contains 15 mcg of hemagglutinin antigen (HA).Follow-up visits will be scheduled 28 days after each dose and at day 208+/- 14 days for blood work. The day of administration of the first vaccine dose is counted as day 0. At each of these visits, blood will be collected to assess for immunogenicity. Research participants will be given a diary card to record symptoms for 28 days . They will be asked to bring this diary back at the next visit. Other vaccine-related adverse events will also be collected by retrospective chart review.

Children and young adults between the ages of 6 months and 21 years and 13 kg or greater in body weight who have an underlying diagnosis of cancer, HIV, sickle cell disease or receipt of a stem cell transplant more than a year prior to study entry and who will receive inactivated H1N1 swine-origin monovalent influenza vaccine in the winter/fall of 2009-2010 as part of their routine clinical care.

  Eligibility

Ages Eligible for Study:   6 Months to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Children and young adults between the ages of 6 months and 21 years and 13 kg or greater in body weight who have an underlying diagnosis of cancer, HIV, sickle cell disease or receipt of a stem cell transplant more than a year prior to study entry and who will receive inactivated H1N1 swine-origin monovalent influenza vaccine in the winter/fall of 2009-2010 as part of their routine clinical care. Stem cell transplant recipients in the first year following their transplant are excluded.

Criteria

Inclusion Criteria:

  • Age 6 months through 21 years of age at the time of entry into the study;
  • Body weight of 13 kg or greater at the time of entry into the study;
  • Participant is immunocompromised due to cancer, HIV, or sickle cell disease or receipt of a stem cell transplant;
  • Participant or participant's parent/legal guardian available by telephone during the course of the study;
  • Written informed consent (and assent, if applicable) obtained;
  • Potential research participant received or will receive H1N1 swine-origin monovalent influenza vaccine within 24 hours of study entry.

Exclusion Criteria:

  • Proven history, by RT-PCR, of H1N1 swine-origin influenza infection prior to study entry;
  • Receipt of a stem cell transplant within one year prior to study entry;
  • Participation in P1088 study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000571

Locations
United States, Tennessee
St.Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Hana Hakim, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01000571     History of Changes
Other Study ID Numbers: SOVAC
Study First Received: October 19, 2009
Last Updated: October 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
H1N1 pandemic flu

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 15, 2014