Influenza Vaccine Post Allogeneic Transplant

NCT01215981 | Terminated Results DMC

• 3 other identifiers: 2010NTLS050MT2010-08R1007M86296
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Study Design: This is a randomized, single center study to evaluate immune responses to the seasonal influenza vaccine in allogeneic hematopoietic stem cell transplant (HSCT) recipients who receive one vaccine or two vaccine doses one month apart. In addition, a cohort of healthy adult volunteers will be recruited as controls to confirm immune response to a single influenza vaccine.

Conditions

Hematopoietic Stem Cell Transplant; Hematologic Malignancy

Keywords

influenza vaccine

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With T-Cell Based Immune Response to Vaccine

  The primary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific T cell immune responses. Response is defined as 4 times above the background after a filter plate was developed. Response is listed as a number of subjects (evaluable) that successfully responded.

  8 Weeks After Vaccination

Secondary Outcomes (1)

• Number of Subjects With H3 Based Immune Response to Vaccine

  8 Weeks After Vaccination

Study Arms (2)

Participants Receiving 1 Dose of Vaccine

ACTIVE COMPARATOR

Control group participants (healthy volunteers): * Age 18 to 50 years * No history of previous allergic reaction to influenza vaccine, known egg allergy or Guillan-Barre Syndrome * No flu vaccine in previous 4 months and/or HSCT recipients who are greater than 60 days post transplant.

Biological: Influenza vaccine

Participants Receiving 2 Doses of Vaccine

ACTIVE COMPARATOR

Hematopoietic stem cell transplant (HSCT) recipients who are greater than 60 days post transplant.

Biological: Influenza vaccine

Interventions

Influenza vaccine BIOLOGICAL

One dose of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B

Also known as: H1N1, H3N2, Influenza A vaccine, Influenza B vaccine

Participants Receiving 1 Dose of Vaccine

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient Population
• HSCT recipients who are greater than 60 days post transplant.
• Age 6 months and older who are greater than 60 days post post allogeneic hematopoietic cell transplant
• Show neutrophil recovery, platelet count \> 50,000/mm3 (may be transfused), no known disease relapse
• No history of previous allergic reaction to influenza vaccine, known egg allergy or Guillan-Barre Syndrome
• No flu vaccine in previous 4 months, no Campath in previous 6 months, no intravenous immune globulin (IVIG) in previous 3 months
• Controls:
• Age 18 to 50 years
• No history of previous allergic reaction to influenza vaccine, known egg allergy or Guillan-Barre Syndrome
• No flu vaccine in previous 4 months

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Links

• Randomized Trial of One versus Two Doses of Influenza Vaccine after Allogeneic Transplantation

MeSH Terms

Conditions

Hematologic Neoplasms; Influenza, Human

Interventions

Influenza Vaccines; Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Michael Verneris, M.D.
• Organization: Masonic Cancer Center, University of Minnesota

verneris@umn.edu

612-626-2961

Study Officials

• Michael Verneris, M.D.

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2010
• First Posted: October 7, 2010
• Study Start: September 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 28, 2017
• Results First Posted: August 16, 2016

Record last verified: 2017-12

Locations

US (1)