← Back to Search

Virus Therapy

High Dose Flu Vaccine for Bone Marrow Transplant Recipients

Phase 2

Waitlist Available

Led By Natasha Halasa, MD, MPH

Research Sponsored by Vanderbilt-Ingram Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Parent/legal guardian willing and capable of signing written informed consent

Allogeneic HSCT recipients who are 3-35 months post-transplant and 3-17 years of age, inclusive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during the influenza season, up to 6 months

Awards & highlights

Study Summary

This trial is testing how well a higher dose flu vaccine works in children who have undergone a stem cell transplant. The hope is that the higher dose will build a better immune response and provide better protection against the flu.

Who is the study for?

This trial is for children aged 3-17 who've had a donor stem cell transplant 3-35 months ago. They should be available throughout the study, have stable GVHD, and not be allergic to eggs or have certain infections like HIV. Pregnant females and those with recent vaccines or acute illnesses are excluded.Check my eligibility

What is being tested?

The trial tests whether high dose flu vaccines (Trivalent or Quadrivalent) create stronger immune responses in these children compared to standard doses. It's randomized, meaning kids get assigned by chance to different vaccine types.See study design

What are the potential side effects?

Possible side effects from the flu vaccines may include soreness at the injection site, fever, muscle aches, and fatigue. Severe allergic reactions are rare but can occur in some individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My parent or guardian can sign the consent form for me.

Select...

I had a stem cell transplant between 3 months and 3 years ago and am between 3 and 17 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the influenza season, up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the influenza season, up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the influenza season, up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers

Secondary outcome measures

Influenza

Proportion of Solicited Local and Systemic Adverse Events

T and B Cell Phenotype Assessed by Mass Cytometry

+1 more

Side effects data

From 2013 Phase 4 trial • 300 Patients • NCT01859143

Nasal congestion

Sinus congestion

Upper respiratory tract infection

Sneezing

Nausea

100%

80%

60%

40%

20%

Study treatment Arm

TRIVALENT VACCINE

PLACEBO

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group 1 - High Dose TIVExperimental Treatment2 Interventions

Patients receive HD-TIV intramuscularly (IM) on day 0 and day 28.

Group II: Group 2 - Standard Dose QIVActive Control2 Interventions

Patients receive standard dose QIV IM on day 0 and day 28.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trivalent Influenza Vaccine

2010

Completed Phase 4

~2630

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,983 Total Patients Enrolled

Vanderbilt-Ingram Cancer CenterLead Sponsor

213 Previous Clinical Trials

60,763 Total Patients Enrolled

Natasha Halasa, MD, MPHPrincipal InvestigatorVanderbilt University

Media Library

High Dose Flu Vaccine (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02860039 — Phase 2

Bone Marrow Transplant Recipient Research Study Groups: Group 2 - Standard Dose QIV, Group 1 - High Dose TIV

Bone Marrow Transplant Recipient Clinical Trial 2023: High Dose Flu Vaccine Highlights & Side Effects. Trial Name: NCT02860039 — Phase 2

High Dose Flu Vaccine (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02860039 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a proliferation of locations in Canada conducting this research?

"This research is taking place at 9 different sites, including Kansas City, Columbus and Memphis. It would be prudent to select the closest clinic in order to reduce transportation costs if you decide to take part."

Answered by AI

Are there any remaining slots open for enrolment in this clinical trial?

"Contradictory to the clinicaltrials.gov listing, this clinical trial is not presently accepting patients - it was posted on September 1st 2016 and lastly updated June 16th 2022. Nonetheless, there are currently 2449 other studies enrolling participants at present."

Answered by AI

Are individuals over the age of 40 being accepted into this clinical trial?

"The requirements for this medical experiment stipulate that the ideal participants are aged between 3 to 17. According to research, 321 studies have been conducted with people under 18 and 2244 trials were run with individuals older than 65."

Answered by AI

Is it possible to participate in this research opportunity?

"This clinical trial is enrolling 170 participants aged 3 to 17 with influenza-caused flu. Additional criteria for eligibility include the ability of a parent or legal guardian to be contacted via telephone and/or digital communication, having undergone an allogeneic HSCT within the last 35 months, being available throughout the duration of this study, stable GVHD over 4 weeks prior to enrollment (in spite of fluctuations in systemic immunosuppressive therapy), consent from parents/legal guardians who are able to remain present during this experiment, and platelets counts ≥30 000 before vaccination (for those requiring transfusion: must have had count ≥75 000"

Answered by AI

Has the Trivalent Influenza Vaccine been certified by the FDA?

"Our team at Power rated the safety of Trivalent Influenza Vaccine a 2 due to it being in Phase 2 clinical trials. There is evidence suggesting its safety, but none as yet proving its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

High Dose Flu Vaccine in Treating Children Who Have Undergone Donor Stem Cell Transplant

Natasha Halasa, MD 2016. "High Dose Flu Vaccine in Treating Children Who Have Undergone Donor Stem Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02860039.

All > Influenza