Early Flu Shots in SOT

NCT03327987 | Withdrawn

• 1 other identifier: 17-5960
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Although time from transplant has been a factor in vaccine response, there is limited data on immunizations that occur in the first post-transplant year, and there are no data that suggest influenza vaccination early post-transplant may have any adverse effects on the graft. It is suggested that early vaccinations may lead to reduced immunogenicity due to induction immunosuppression. However, not vaccinating patients may leave them vulnerable to influenza infection for a period of time. This study is designed to look at the immunogenicity and side effects of the standard of care influenza vaccine in patients between 31 and 365 days post-transplant.

Conditions

Influenza; Solid Organ Transplant

Keywords

vaccine immunogenicity; vaccine safety

Outcome Measures

Primary Outcomes (1)

• Vaccine immunogenicity

  Vaccine immunogenicity based on assessment of pre- and post-vaccine (4 weeks) antibody titer. A positive vaccine response will be defined based on: * Seroconversion rate: serological response with a four-fold or greater increase in HAI antibody titers to each of the three antigens in the vaccine, and * Seroprotection rate: HAI titers of ≥1:40 to each of the three antigens post-immunization.

  4 weeks

Secondary Outcomes (5)

• Safety- adverse events

  7 days

• Safety- graft rejection

  6 months

• Safety- HLA

  4 weeks

• Vaccine efficacy- CMI

  4 weeks

• Vaccine efficacy- infection

  6 months

Study Arms (3)

31-90 days

Patient 31-90 days after transplantation receiving standard of care annual 2017-2018 influenza vaccine.

Biological: standard of care influenza vaccine

91-180 days

91-180 days after transplantation receiving standard of care annual 2017-2018 influenza vaccine.

Biological: standard of care influenza vaccine

181-365 days

181-365 days after transplantation receiving standard of care annual 2017-2018 influenza vaccine.

Biological: standard of care influenza vaccine

Interventions

standard of care influenza vaccine BIOLOGICAL

The standard of care annual 2017-2018 influenza vaccine will be used for this study.

Also known as: annual influenza vaccine

181-365 days; 31-90 days; 91-180 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult solid organ transplant recipients between 31 and 365 days post-transplant.

You may qualify if:

• Kidney, liver or pancreas transplant recipients on at least one immunosuppressive medication
• Age ≥ 18
• Outpatient status
• Greater than 30 days post-transplant

You may not qualify if:

• Has already received influenza vaccination for 2017-2018 season
• Egg allergy or allergy to previous influenza vaccine
• Febrile illness in the past one week
• Active Cytomegalovirus viremia
• Use of Rituximab in the past one year
• Ongoing or recent (in past 30 days) therapy for acute rejection
• Chronic kidney insufficiency (creatinine clearance ≤30mL/min or dialysis-dependent
• Previous life-threatening reaction to influenza vaccine (i.e., Guillain Barre Syndrome)
• Receipt of intravenous immunoglobulin (IVIG) in the past 30 days or planning to receive IVIG in the next four weeks

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network, Toronto General Hospital, Multi-Organ Transplant

Toronto, Ontario, M5G2N2, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, whole blood

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Deepali Kumar, MD

  UHN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: November 1, 2017
• Study Start: May 7, 2019
• Primary Completion: May 7, 2019
• Study Completion: May 7, 2019
• Last Updated: October 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)