Influenza, Human Clinical Trial
Official title:
Phase IV, Pilot, Randomized, Investigator-blinded, Study to Evaluate the Reactogenicity and Immunogenicity of Standard-dose Versus High-dose Inactivated Influenza Vaccine After Kidney, Heart and Lung Transplantation.
Influenza infection in recipients of solid organ transplants recipients while on maintenance immunosuppressant therapy is associated with increased morbidity and mortality. Although influenza vaccination is recommended in these high-risk patients, safety and immunogenicity of commercially available different strengths of influenza vaccine have not been established. The primary study objective is to determine the safety and immunogenicity of Fluzone and Fluzone High-Dose, with a secondary objective to determine the tolerability and efficacy of two different strengths of trivalent influenza vaccine (TIV, flu vaccine). Both vaccines are commercially available for use in the general population. Fluzone is approved for use in 6 months of age and older, and Fluzone High-Dose is approved for use in 65 years of age and older. This is an exploratory, open-label, parallel group, observer blinded, prospective study. All recipients of kidney, lung, heart transplants who attend for post-transplant follow-up, at least 30-days after transplantation at Inova Fairfax Hospital Transplant Center will be eligible for enrollment. Enrolled patients will be followed for three months (a total of 4 visits) following enrollment and randomization: day 0 (enrollment) and follow-up visits at weeks 1, 4, 8, and 12.
A potential strategy to enhance immune responses to influenza vaccine in this patient population could be to use different strengths of TIV. One of the pathways that can improve the immunogenicity of inactivated vaccines is to increase the dose of influenza antigens contained in the vaccine. Studies have demonstrated that increasing the dose of the influenza virus hemagglutinin for each of the commonly encountered viral strains beyond the conventional dose of 15 microgram for each strain is associated with dose-dependent increase in serum antibody titers. Influenza TIV is commercially available in two different strengths, Fluzone as well as Fluzone High-Dose, and it is valuable because of variable immunogenic potency of different strengths. Fluzone is approved for use in persons 6 months of age and older. High-dose Fluzone is approved for use in persons 65 years of age and older. The purpose of this exploratory study is to assess the safety, tolerability, and immunogenicity of these two commercially available different strengths of TIV in solid organ transplant recipients (kidney, heart and lung) in the period after 30 days after transplant procedure. We will evaluate the safety, tolerability (reactogenicity) and immunogenicity of two different strengths of commercially available TIV in a single center, cluster randomization, investigator blinded, study by enrolling patients in the post-transplant clinic at Inova Fairfax Hospital from: August 1, 2013 - March 31, 2014; and August 1, 2014 to March 31, 2015. Study protocol will remain active till December 31, 2016. All bio-specimens will be stored till December 31, 2016. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03275389 -
A Study to Evaluate the Reactogenicity, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults Aged 18 to 39 Years
|
Phase 1 | |
Completed |
NCT03442582 -
Afluria Pregnancy Registry
|
||
Completed |
NCT05981846 -
A Phase II Trial to Evaluate the Safety and Immunogenicity of BIMERVAX® When Coadministered With Seasonal Influenza Vaccine (SIIV) in Adults Older Than 65 Years of Age Fully Vaccinated Against COVID-19
|
Phase 2 | |
Completed |
NCT05044195 -
A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age
|
Phase 3 | |
Completed |
NCT02914275 -
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age.
|
Phase 3 | |
Completed |
NCT04590066 -
Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates at a Large Retail Pharmacy
|
N/A | |
Recruiting |
NCT03778203 -
Development of Childhood Anti-influenza Immunity
|
Phase 4 | |
Completed |
NCT04527614 -
Influence of Prior Infection With COVID-19 on Occurrence of Influenza-like Illness or Acute Respiratory Infection
|
N/A | |
Terminated |
NCT03658629 -
Phase 2 Dose and Formulation Confirmation of Quad-NIV in Older Adults
|
Phase 2 | |
Completed |
NCT05269290 -
Efficacy and Safety of Ingavirin®, Syrup, 30 mg/5 ml, in Children With Influenza and Other Acute Respiratory Viral Infections
|
Phase 3 | |
Completed |
NCT06385821 -
A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus
|
Phase 3 | |
Withdrawn |
NCT02883972 -
Childhood Influenza Immunisation Invitation Trial in Schools
|
N/A | |
Completed |
NCT02867358 -
A Clinical Trial of KT07 Capsule in the U.S.A
|
Phase 2 | |
Completed |
NCT02984280 -
Specific Respiratory Infections as Triggers of Acute Medical Events
|
N/A | |
Completed |
NCT02998996 -
Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU
|
Phase 1/Phase 2 | |
Completed |
NCT02545543 -
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age
|
Phase 3 | |
Completed |
NCT02212106 -
A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years
|
Phase 4 | |
Completed |
NCT02243774 -
Mail Outreach To Increase Vaccination Acceptance Through Engagement
|
N/A | |
Completed |
NCT02621164 -
Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents
|
Phase 3 | |
Completed |
NCT02344134 -
Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly Subjects
|
Phase 3 |