Clinical Trials

Scientists at the medical school are conducting hundreds of clinical trials daily. Browse our list of actively recruiting clinical trials below to learn more and find out how you may be able to participate. Learn more about all the medical school's trials via the Feinberg Office of Research Clinical Trials page.

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Trials
High vs. Standard Dose Influenza Vaccine in Adult SOT Recipients The influenza virus is a significant cause of morbidity in adult solid organ transplant (SOT) recipients. However, these individuals show a suboptimal response to vaccines including the standard-dose (SD) inactivated influenza vaccine (IIV). Recent studies have investigated two strategies to overcome poor immune responses in SOT recipients: (1) administration … The influenza virus is a significant cause of morbidity in adult solid organ transplant (SOT) recipients. However, these individuals show a suboptimal response to vaccines including the standard-dose (SD) inactivated influenza vaccine (IIV). Recent studies have investigated two strategies to overcome poor immune responses in SOT recipients: (1) administration of high-dose (HD)-IIV compared to SD-IIV and (2) two doses of SD-IIV compared to one dose of SD-IIV in the same influenza season. The first study compared HD-IIV vs. SD-IIV in adult SOT and noted HD-IIV was safe and reported higher immunogenicity; however, the median post-transplant period was 38 months. In another phase II trial of adult SOT recipients, two doses of SD-IIV a month apart compared to one-dose SD-IIV revealed increased immunogenicity, with a median post-transplantation period of 18 months. Therefore, these studies lack evaluation in the early post-transplantation period in this vulnerable population when influenza disease is most severe. The administration of two-doses of HD-IIV in the same influenza season has also not been studied in SOT recipients. Moreover, the vast majority of SOT influenza vaccinations studies have not substantively evaluated prolonged immunogenicity. Thus, the optimal immunization strategy for SOT recipients less than 12 months post-transplant is poorly-defined. In addition, the immunologic predictors and correlates of influenza vaccine immunogenicity in SOT recipients have not been defined. The investigators hypothesize that adult solid organ transplant recipients that are 1-11 months out from transplant and are receiving high-dose inactivated influenza vaccine will have higher hemagglutination inhibition (HAI) geometric mean titers to influenza A antigens compared to adult SOT recipients receiving standard-dose inactivated influenza vaccine. To test this hypothesis and address the above critical knowledge gaps, The investigators propose to conduct a phase II multicenter randomized controlled trial comparing either two doses HD-IIV, two doses of SD-IIV, or one-dose of HD-IIV in adult kidney, heart, and liver SOT recipients 1-11 months post-transplantation. The results of this study will address significant gaps in knowledge regarding influenza vaccine strategies and immune responses in adult SOT recipients and will guide vaccine recommendations in this vulnerable population. Eligibility Criteria Criteria Inclusion criteria Adult SOT recipients who have undergone kidney, heart, and/or liver transplantation I. Multiple organ recipients are permitted (i.e. any combination of organs including kidney, heart and/or liver). II. Subjects undergoing re-transplantation are permitted Age ≥18 years at vaccination ≥1 month and <12 months post-SOT Anticipated to be available for duration of study Can be reached by telephone, email, or text message Exclusion criteria History of severe hypersensitivity to previous influenza vaccination or anaphylaxis to eggs/egg protein History of Guillain-Barre syndrome History of known active infection with HIV History of known severe latex hypersensitivity History of receiving the current season's influenza vaccine post-transplant prior to enrollment in the study Pregnant female Proven influenza disease after September 1st and before first study vaccine (patient can still receive the second influenza vaccination despite proven influenza disease once enrolled) History of lung or intestine transplant CMVIG/IVIG/SCIG receipt in the 28 days prior to or planned administration within 84-126 days of the calendar date of first vaccination Subjects must have a platelet count of <20,000 to receive the immunizations Principal Investigator Guenette, Alexis Nicole ClinicalTrials.gov IdentifierNCT04613206IRB number STU00213835 More Info Email Welsh, Fallon Phone 312 694 0240 Copy Study URL to Clipboard Copy
Study for Desensitization of Chronic Kidney Disease Adult Patients in Need of a Kidney Transplant Who Are Highly Sensitized to Human Leukocyte Antigen Brief Summary:The primary objective of the study is to assess the safety and tolerability of REGN5459 (Part A) or REGN5458 (Part B) as monotherapy in patients with chronic kidney disease (CKD) who need kidney transplantation and are highly sensitized to human leukocyte antigen (HLA).The secondary objectives of the … Brief Summary: The primary objective of the study is to assess the safety and tolerability of REGN5459 (Part A) or REGN5458 (Part B) as monotherapy in patients with chronic kidney disease (CKD) who need kidney transplantation and are highly sensitized to human leukocyte antigen (HLA). The secondary objectives of the study are to determine/assess the following for REGN5459 (Part A) or REGN5458 (Part B): Dose regimen(s) that result in a clinically meaningful reduction of anti-HLA alloantibody levels Effect on calculated panel-reactive antibody (cPRA) levels Time to maximal and clinically meaningful reduction in anti-HLA alloantibody levels Duration of the effect of study drug on the reduction of anti-HLA alloantibodies Effect on circulating immunoglobulin (Ig) classes (isotypes) Pharmacokinetics (PK) properties Immunogenicity Eligibility Criteria Has Chronic Kidney Disease (CKD) requiring hemodialysis, and awaiting kidney transplant on the United Network for Organ Sharing (UNOS), with a cPRA ≥99.9%, or those with a cPRA >98% (98.1% to 99.8%) who have spent 5 years or longer on the waitlist Adequate hematologic and adequate hepatic function as defined in the protocol Willing and able to comply with clinic visits and study-related procedures Principal Investigator Friedewald, John J Location(s) Map it 676 N. Saint Clair St. Ninteenth Floor, Suite 1900 Chicago, IL ClinicalTrials.gov IdentifierNCT05092347IRB number STU00217349 More Info Email Tremblay, Sue Phone Copy Study URL to Clipboard Copy

Trials

High vs. Standard Dose Influenza Vaccine in Adult SOT Recipients

The influenza virus is a significant cause of morbidity in adult solid organ transplant (SOT) recipients. However, these individuals show a suboptimal response to vaccines including the standard-dose (SD) inactivated influenza vaccine (IIV). Recent studies have investigated two strategies to overcome poor immune responses in SOT recipients: (1) administration of high-dose (HD)-IIV compared to SD-IIV and (2) two doses of SD-IIV compared to one dose of SD-IIV in the same influenza season. The first study compared HD-IIV vs. SD-IIV in adult SOT and noted HD-IIV was safe and reported higher immunogenicity; however, the median post-transplant period was 38 months. In another phase II trial of adult SOT recipients, two doses of SD-IIV a month apart compared to one-dose SD-IIV revealed increased immunogenicity, with a median post-transplantation period of 18 months. Therefore, these studies lack evaluation in the early post-transplantation period in this vulnerable population when influenza disease is most severe. The administration of two-doses of HD-IIV in the same influenza season has also not been studied in SOT recipients. Moreover, the vast majority of SOT influenza vaccinations studies have not substantively evaluated prolonged immunogenicity. Thus, the optimal immunization strategy for SOT recipients less than 12 months post-transplant is poorly-defined. In addition, the immunologic predictors and correlates of influenza vaccine immunogenicity in SOT recipients have not been defined. The investigators hypothesize that adult solid organ transplant recipients that are 1-11 months out from transplant and are receiving high-dose inactivated influenza vaccine will have higher hemagglutination inhibition (HAI) geometric mean titers to influenza A antigens compared to adult SOT recipients receiving standard-dose inactivated influenza vaccine. To test this hypothesis and address the above critical knowledge gaps, The investigators propose to conduct a phase II multicenter randomized controlled trial comparing either two doses HD-IIV, two doses of SD-IIV, or one-dose of HD-IIV in adult kidney, heart, and liver SOT recipients 1-11 months post-transplantation. The results of this study will address significant gaps in knowledge regarding influenza vaccine strategies and immune responses in adult SOT recipients and will guide vaccine recommendations in this vulnerable population.

Eligibility Criteria

Criteria

Inclusion criteria

Adult SOT recipients who have undergone kidney, heart, and/or liver transplantation I. Multiple organ recipients are permitted (i.e. any combination of organs including kidney, heart and/or liver).

II. Subjects undergoing re-transplantation are permitted

Age ≥18 years at vaccination

≥1 month and <12 months post-SOT

Anticipated to be available for duration of study

Can be reached by telephone, email, or text message

Exclusion criteria

History of severe hypersensitivity to previous influenza vaccination or anaphylaxis to eggs/egg protein

History of Guillain-Barre syndrome

History of known active infection with HIV

History of known severe latex hypersensitivity

History of receiving the current season's influenza vaccine post-transplant prior to enrollment in the study

Pregnant female

Proven influenza disease after September 1st and before first study vaccine (patient can still receive the second influenza vaccination despite proven influenza disease once enrolled)

History of lung or intestine transplant

CMVIG/IVIG/SCIG receipt in the 28 days prior to or planned administration within 84-126 days of the calendar date of first vaccination

Subjects must have a platelet count of <20,000 to receive the immunizations

Principal Investigator

Guenette, Alexis Nicole

ClinicalTrials.gov IdentifierNCT04613206IRB number STU00213835

More Info

Email Welsh, Fallon Phone 312 694 0240

Copy Study URL to Clipboard Copy

Study for Desensitization of Chronic Kidney Disease Adult Patients in Need of a Kidney Transplant Who Are Highly Sensitized to Human Leukocyte Antigen

Brief Summary:The primary objective of the study is to assess the safety and tolerability of REGN5459 (Part A) or REGN5458 (Part B) as monotherapy in patients with chronic kidney disease (CKD) who need kidney transplantation and are highly sensitized to human leukocyte antigen (HLA).The secondary objectives of the …

Brief Summary:

The primary objective of the study is to assess the safety and tolerability of REGN5459 (Part A) or REGN5458 (Part B) as monotherapy in patients with chronic kidney disease (CKD) who need kidney transplantation and are highly sensitized to human leukocyte antigen (HLA).

The secondary objectives of the study are to determine/assess the following for REGN5459 (Part A) or REGN5458 (Part B):

Dose regimen(s) that result in a clinically meaningful reduction of anti-HLA alloantibody levels
Effect on calculated panel-reactive antibody (cPRA) levels
Time to maximal and clinically meaningful reduction in anti-HLA alloantibody levels
Duration of the effect of study drug on the reduction of anti-HLA alloantibodies
Effect on circulating immunoglobulin (Ig) classes (isotypes)
Pharmacokinetics (PK) properties
Immunogenicity

Eligibility Criteria

Has Chronic Kidney Disease (CKD) requiring hemodialysis, and awaiting kidney transplant on the United Network for Organ Sharing (UNOS), with a cPRA ≥99.9%, or those with a cPRA >98% (98.1% to 99.8%) who have spent 5 years or longer on the waitlist

Adequate hematologic and adequate hepatic function as defined in the protocol

Willing and able to comply with clinic visits and study-related procedures

Principal Investigator

Friedewald, John J

Location(s)

Map it 676 N. Saint Clair St. Ninteenth Floor, Suite 1900
Chicago, IL

ClinicalTrials.gov IdentifierNCT05092347IRB number STU00217349

More Info

Email Tremblay, Sue Phone

Copy Study URL to Clipboard Copy