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Virus Therapy

High vs. Standard Dose Flu Vaccine for Transplant Patients (PSOT Trial)

Phase 2
Recruiting
Led By Natasha Halasa, MD. MPH
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 days after vaccine 2
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to find out what's the best vaccine strategy for pediatric organ transplant patients to prevent influenza virus infections.

Who is the study for?
This trial is for pediatric solid organ transplant recipients aged 3-17, within 1 to 24 months post-transplant. It includes those who've had kidney, heart, or liver transplants and are available for the study duration. Excluded are patients with recent immune treatments, severe allergies, HIV positive status, pregnancy/lactation in females of childbearing age without a negative pregnancy test prior to each vaccine dose.
What is being tested?
The trial tests whether two doses of High Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV) provide better immune response compared to Standard Dose (SD) in children who have received an organ transplant less than two years ago. The safety and increase in protective antibodies will be measured.
What are the potential side effects?
While not explicitly listed here, potential side effects may include typical reactions to vaccines such as soreness at injection site, fever, fatigue or allergic reactions. Since it's a high-dose vaccine being tested on immunocompromised children, monitoring for any unusual side effects will be crucial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 days after vaccine 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days after vaccine 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety: solicited local and systemic post-administration reactions
Secondary study objectives
Durability of immunogenicity
Immunogenicity: Hemagglutination Inhibition (HAI) titers
The number of participants achieving seroprotection and seroconversion for influenza virus.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Two Doses Standard Dose Quadrivalent Inactivated Influenza VaccineExperimental Treatment1 Intervention
Two doses of SD-QIV (0.5 mL; 15µg of each influenza antigen) 28-42 days apart
Group II: Two Doses High Dose Quadrivalent Inactivated Influenza VaccineExperimental Treatment1 Intervention
Two doses of HD-QIV (0.7 mL; 60µg of each influenza antigen) 28-42 days apart

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,335 Previous Clinical Trials
5,382,492 Total Patients Enrolled
Vanderbilt University Medical CenterLead Sponsor
906 Previous Clinical Trials
934,257 Total Patients Enrolled
Children's Hospital Medical Center, CincinnatiOTHER
839 Previous Clinical Trials
6,565,291 Total Patients Enrolled
Lucile Packard Children's HospitalOTHER
15 Previous Clinical Trials
2,459 Total Patients Enrolled
University of PittsburghOTHER
1,792 Previous Clinical Trials
16,359,664 Total Patients Enrolled
Ann & Robert H Lurie Children's Hospital of ChicagoOTHER
273 Previous Clinical Trials
5,185,261 Total Patients Enrolled
Baylor College of MedicineOTHER
1,028 Previous Clinical Trials
6,029,850 Total Patients Enrolled
Children's Mercy Hospital Kansas CityOTHER
257 Previous Clinical Trials
940,184 Total Patients Enrolled
Children's Healthcare of AtlantaOTHER
169 Previous Clinical Trials
106,806 Total Patients Enrolled
Natasha Halasa, MD. MPHPrincipal InvestigatorVanderbilt University Medical Center
1 Previous Clinical Trials
270 Total Patients Enrolled

Media Library

High Dose Quadrivalent Inactivated Influenza Vaccine (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05947071 — Phase 2
Transplant Infection Research Study Groups: Two Doses High Dose Quadrivalent Inactivated Influenza Vaccine, Two Doses Standard Dose Quadrivalent Inactivated Influenza Vaccine
Transplant Infection Clinical Trial 2023: High Dose Quadrivalent Inactivated Influenza Vaccine Highlights & Side Effects. Trial Name: NCT05947071 — Phase 2
High Dose Quadrivalent Inactivated Influenza Vaccine (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05947071 — Phase 2
~208 spots leftby Jul 2027
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