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A Study of CMV Vaccine (HB-101) in Kidney Transplant Patients

Primary Purpose

Cytomegalovirus (CMV) Infection, Kidney Transplantation

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
HB-101 vaccine
placebo
Sponsored by
Hookipa Biotech GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cytomegalovirus (CMV) Infection focused on measuring solid organ transplantation, vaccine

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients who meet all of the following key inclusion criteria will be eligible to participate in the study:

  1. Male or female patients 18 years of age or older.
  2. Patients must be eligible to undergo kidney transplantation from a living donor as per institutional standards.
  3. For Groups 1 and 2 only: Patients must be CMV immunoglobulin G (IgG) seronegative (-) and receiving kidney for transplantation from donors who are CMV IgG seropositive (+).
  4. For Group 3 only: Patients must be CMV immunoglobulin G (IgG) seropositive (+) and receiving kidney for transplantation from donors who are either CMV IgG seronegative (-) or seropositive (+).
  5. Patients who would comply with the requirements of this protocol (e.g., return for follow up visits), as judged by the investigator.

Exclusion Criteria:

Patients who meet any of the following key criteria will be excluded from the study:

  1. Patients planning to undergo multi-organ transplantation.
  2. Patients participating in another interventional clinical study.
  3. Previous vaccination with an investigational CMV vaccine.
  4. Any confirmed or suspected immunodeficiency disorder (based on medical history and physical examination) that could interfere with the immune response or that presents a risk for the patient to receive a vaccine candidate in development.
  5. Treatment with any chronic immunosuppressive medication or other immuno modifying drugs within 6 months prior to study entry. However, inhaled and topical steroids and low-dose oral corticosteroids (<10 milligrams a day of prednisone or equivalent) are allowed.
  6. Prior history of CMV disease or CMV infection requiring anti-viral therapy
  7. Patients with a rash, dermatological condition, or tattoo in the area of the injection site(s) that could interfere with administration site reaction rating. (Note: The injection site(s) can be the non-dominant arm [most preferred injection site], dominant arm, or either thigh [least preferred injection site], as judged by the investigator).
  8. It is anticipated that the patient will be unavailable to complete the study follow-up.
  9. Patients who are highly sensitized or who are likely to undergo desensitization at time of transplant (e.g., donor-specific antibody titers at the local laboratory >2000).

Sites / Locations

  • The 1917 Clinic at UAB
  • California Institute of Renal Research
  • UC Davis Health Systems
  • University of Colorado Hospital
  • Indiana University/IU Health
  • Massachusetts General Hospital
  • The Christ Hospital
  • University of Cincinnati (UC) - College of Medicine
  • University Hospitals Cleveland Medical Center
  • Oklahoma University
  • Thomas E. Starzl Transplantation Institute
  • South Texas Accelerated Research
  • Swedish Medical Center
  • Odense University Hospital
  • Centre Hospitalier Universitaire de Bordeaux Hôpital Pellegrin
  • Hopital Necker-Enfants Malades
  • CHU de Toulouse - Hospital Rangueil
  • Charite Universitatsmedizin Berlin
  • Universitatsklinikum Essen
  • Oslo University Hospital
  • Belfast Health and Social Care Trust
  • Cardiff & Vale University Health Board
  • St James's University Hospital
  • Leicester General Hospital
  • The Royal Free Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

HB-101 vaccine preemptive

Placebo preemptive

HB-101 vaccine prophylactic

Placebo prophylactic

HB-101 vaccine: CMV (+) patients-Prophylactic Management

HB-101 vaccine: CMV (+) patients-Preemptive Management

Arm Description

Three doses of HB-101 vaccine will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post-transplant patients will be monitored per preemptive institutional standard.

Three doses of placebo will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of placebo will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post-transplant patients will be monitored per preemptive institutional standard.

Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard.

Three doses of placebo will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of placebo will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard.

Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard.

Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will follow pre-emptive management per institutional standard.

Outcomes

Primary Outcome Measures

The safety of HB-101.
Assess the incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
The immunogenicity of HB-101.
Central statistics will be performed for the following immunogenicity parameters: CMV neut, CMV ELISPOT pp65, and CMV ELISPOT gB to determine immunogenicity of HB-101.
The reactogenicity of HB-101.
Assess the incidence and severity of localized or generalized injection site reactions to determine the reactogenicity of HB-101.
Measure Oral Body Temperature.
Measure Oral Body Temperature in degrees Celsius prior to study drug administrations and seven days after. Three doses of the study drug will be administered up to 3 months after randomization.
Measure Respiration Rate.
Measure respiration rate in breaths per minute prior to study drug administration and seven days after. Three doses of the study drug will be administered up to 3 months after randomization.
Measure Blood Pressure.
Measure Blood Pressure (diastolic and systolic) in mmHg prior to study drug administration and seven days after. Three doses of the study drug will be administered up to 3 months after randomization.
Measure Weight.
Measure Weight in Kilograms prior to study drug administration and seven days after. Three doses of the study drug will be administered up to 3 months after randomization.
Cellular immunogenicity analyses the day of transplant and 3, 6 and 9 months after the transplant and 12 months at the end of study visit.
Cellular immunogenicity analyses will be conducted at the day of transplant, and 3, 6, 9 months after the transplant and 12 months at the end of study visit (a total of 12 months post-transplant follow up). Cellular immunogenicity analyses of CMV pp65-specific interferon γ (IFN-γ) and CMV gB-specific IFN-γ.
Humoral immunogenicity analyses prior to the first dose of the study drug (3 months prior to transplant), on the day of transplant, and at the end of study visit (up to 12 months post-transplant follow-up to a total of 15 months).
Analysis of CMV-neutralization on MRC-5 cells.

Secondary Outcome Measures

Time to clinically significant CMV infection.
Measure the time to clinically significant CMV infection, CMV disease, CMV syndrome, quantifiable CMV DNAemia, peak CMV DNAemia level, duration of CMV DNAemia above the limit of quantitation, graft failure, and organ rejection for CMV seronegative (-) recipients awaiting kidney transplantation from a CMV seropositive (+) donor and followed by CMV preemptive therapy post-transplant.
Incidence to clinically significant CMV infection.
Measure the incidence to clinically significant CMV infection, CMV disease, CMV syndrome, quantifiable CMV DNAemia, peak CMV DNAemia level, duration of CMV DNAemia above the limit of quantitation, graft failure, and organ rejection for CMV seronegative (-) recipients awaiting kidney transplantation from a CMV seropositive (+) donor and followed by CMV preemptive therapy post-transplant.
The incidence of CMV viremia requiring anti viral therapy.
Measure the incidence of CMV viremia requiring anti viral therapy for CMV seronegative (-) recipients awaiting kidney transplantation from a CMV seropositive (+) donor and to be treated prophylactically for CMV post transplant.
The time to CMV viremia requiring anti viral therapy.
Measure the time to CMV viremia requiring anti viral therapy for CMV seronegative (-) recipients awaiting kidney transplantation from a CMV seropositive (+) donor and to be treated prophylactically for CMV post transplant.
The incidence of anti-CMV therapy courses required.
Measure the incidence of anti-CMV therapy courses (at therapeutic doses) required in CMV seropositive (+) recipients awaiting kidney transplant.
The duration of anti-CMV therapy courses required.
Measure duration (in days) of anti-CMV therapy courses (at therapeutic doses) required in CMV seropositive (+) recipients awaiting kidney transplant.

Full Information

First Posted
May 29, 2018
Last Updated
August 10, 2022
Sponsor
Hookipa Biotech GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT03629080
Brief Title
A Study of CMV Vaccine (HB-101) in Kidney Transplant Patients
Official Title
A Randomized, Placebo-Controlled, Phase 2 Study of HB-101, a Bivalent Cytomegalovirus (CMV) Vaccine, in CMV-Seronegative Recipient (R-) Patients Awaiting Kidney Transplantation From Living CMV-Seropositive Donors (D+).
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 12, 2018 (Actual)
Primary Completion Date
June 22, 2022 (Actual)
Study Completion Date
June 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hookipa Biotech GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
HB-101 is a bivalent recombinant vaccine against human CMV infection. This is a randomized, placebo-controlled, phase 2 study to assess the safety, reactogenicity, immunogenicity, and efficacy of HB-101 in CMV-Seronegative patients receiving a kidney transplant from a CMV-Seropositive living donor and CMV-Seropositive patients.Patients enrolled should have a living donor kidney transplantation ideally planned between two to four months after the first injection of study drug (HB-101 or placebo).
Detailed Description
This is a randomized, placebo-controlled, phase 2 study to assess the safety, reactogenicity, immunogenicity, and efficacy of HB-101 in adult patients awaiting kidney transplantation. For Groups 1 and 2, adult CMV-seronegative (-) patients awaiting kidney transplant from a CMV-seropositive (+) living donor will be enrolled according to treatment intent with regard to the method of CMV prevention after transplant (either preemptive or prophylactic). This will be defined at study enrollment by the investigator and institutional standards. Patients enrolled in Group 1 and 2 will be randomized to receive HB-101 or placebo. For Group 3, adult CMV-seropositive (+) patients awaiting kidney transplant from either CMV-seropositive(+) or CMV-seronegative(-) living donors will be enrolled. Group 3 will be open label where all patients will receive HB-101. The post transplant management for Group 3 patients will also follow either preemptive or prophylactic method per the institution standards. The intent of the study is to administer three doses of the study drug (HB-101 or placebo) prior to transplantation and within proximity to the time of transplantation. However, two doses of study drug will be sufficient for the patients to be included in the efficacy analyses if a third dose of study drug is not feasible due to transplantation timelines. Patients will not receive study drug after transplantation. Patients will be recruited globally from transplant centers. The total duration of the study of each patient participating in the study will be approximately 15 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus (CMV) Infection, Kidney Transplantation
Keywords
solid organ transplantation, vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This phase 2 study will be conducted in three groups stratified by treatment intent. In Group 1, patients will be randomized to receive HB-101 (1a) or placebo (1b) and followed preemptively post-transplant. Approximately 50 patients will be randomized in Group 1. In Group 2, patients will be randomized to receive HB-101 (2a) or placebo (2b) before transplant. Post-transplant patients will receive 3-6 months of anti-viral prophylaxis following institutional standards. Approximately 100 patients will be randomized in Group 2. In Group 3, all patients will receive HB-101 (open label) vaccination(s) prior to their transplant surgery. Post-transplant CMV management will follow either preemptive or prophylactic care as defined at study enrollment by the investigator and institutional standards. Approximately 25 patients will be randomized in Group 3.
Masking
ParticipantCare ProviderInvestigator
Masking Description
The participants, investigators and care providers (study site personnel) will be blinded.
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HB-101 vaccine preemptive
Arm Type
Experimental
Arm Description
Three doses of HB-101 vaccine will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post-transplant patients will be monitored per preemptive institutional standard.
Arm Title
Placebo preemptive
Arm Type
Placebo Comparator
Arm Description
Three doses of placebo will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of placebo will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post-transplant patients will be monitored per preemptive institutional standard.
Arm Title
HB-101 vaccine prophylactic
Arm Type
Experimental
Arm Description
Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard.
Arm Title
Placebo prophylactic
Arm Type
Placebo Comparator
Arm Description
Three doses of placebo will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of placebo will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard.
Arm Title
HB-101 vaccine: CMV (+) patients-Prophylactic Management
Arm Type
Experimental
Arm Description
Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard.
Arm Title
HB-101 vaccine: CMV (+) patients-Preemptive Management
Arm Type
Experimental
Arm Description
Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will follow pre-emptive management per institutional standard.
Intervention Type
Biological
Intervention Name(s)
HB-101 vaccine
Intervention Description
HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV.
Intervention Type
Biological
Intervention Name(s)
placebo
Intervention Description
Saline will be used for placebo.
Primary Outcome Measure Information:
Title
The safety of HB-101.
Description
Assess the incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
Time Frame
15 Months
Title
The immunogenicity of HB-101.
Description
Central statistics will be performed for the following immunogenicity parameters: CMV neut, CMV ELISPOT pp65, and CMV ELISPOT gB to determine immunogenicity of HB-101.
Time Frame
15 Months
Title
The reactogenicity of HB-101.
Description
Assess the incidence and severity of localized or generalized injection site reactions to determine the reactogenicity of HB-101.
Time Frame
15 Months
Title
Measure Oral Body Temperature.
Description
Measure Oral Body Temperature in degrees Celsius prior to study drug administrations and seven days after. Three doses of the study drug will be administered up to 3 months after randomization.
Time Frame
up to 3 months
Title
Measure Respiration Rate.
Description
Measure respiration rate in breaths per minute prior to study drug administration and seven days after. Three doses of the study drug will be administered up to 3 months after randomization.
Time Frame
up to 3 months
Title
Measure Blood Pressure.
Description
Measure Blood Pressure (diastolic and systolic) in mmHg prior to study drug administration and seven days after. Three doses of the study drug will be administered up to 3 months after randomization.
Time Frame
up to 3 months
Title
Measure Weight.
Description
Measure Weight in Kilograms prior to study drug administration and seven days after. Three doses of the study drug will be administered up to 3 months after randomization.
Time Frame
up to 3 months
Title
Cellular immunogenicity analyses the day of transplant and 3, 6 and 9 months after the transplant and 12 months at the end of study visit.
Description
Cellular immunogenicity analyses will be conducted at the day of transplant, and 3, 6, 9 months after the transplant and 12 months at the end of study visit (a total of 12 months post-transplant follow up). Cellular immunogenicity analyses of CMV pp65-specific interferon γ (IFN-γ) and CMV gB-specific IFN-γ.
Time Frame
12 months
Title
Humoral immunogenicity analyses prior to the first dose of the study drug (3 months prior to transplant), on the day of transplant, and at the end of study visit (up to 12 months post-transplant follow-up to a total of 15 months).
Description
Analysis of CMV-neutralization on MRC-5 cells.
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Time to clinically significant CMV infection.
Description
Measure the time to clinically significant CMV infection, CMV disease, CMV syndrome, quantifiable CMV DNAemia, peak CMV DNAemia level, duration of CMV DNAemia above the limit of quantitation, graft failure, and organ rejection for CMV seronegative (-) recipients awaiting kidney transplantation from a CMV seropositive (+) donor and followed by CMV preemptive therapy post-transplant.
Time Frame
12 months
Title
Incidence to clinically significant CMV infection.
Description
Measure the incidence to clinically significant CMV infection, CMV disease, CMV syndrome, quantifiable CMV DNAemia, peak CMV DNAemia level, duration of CMV DNAemia above the limit of quantitation, graft failure, and organ rejection for CMV seronegative (-) recipients awaiting kidney transplantation from a CMV seropositive (+) donor and followed by CMV preemptive therapy post-transplant.
Time Frame
12 months
Title
The incidence of CMV viremia requiring anti viral therapy.
Description
Measure the incidence of CMV viremia requiring anti viral therapy for CMV seronegative (-) recipients awaiting kidney transplantation from a CMV seropositive (+) donor and to be treated prophylactically for CMV post transplant.
Time Frame
12 months
Title
The time to CMV viremia requiring anti viral therapy.
Description
Measure the time to CMV viremia requiring anti viral therapy for CMV seronegative (-) recipients awaiting kidney transplantation from a CMV seropositive (+) donor and to be treated prophylactically for CMV post transplant.
Time Frame
12 months
Title
The incidence of anti-CMV therapy courses required.
Description
Measure the incidence of anti-CMV therapy courses (at therapeutic doses) required in CMV seropositive (+) recipients awaiting kidney transplant.
Time Frame
12 months
Title
The duration of anti-CMV therapy courses required.
Description
Measure duration (in days) of anti-CMV therapy courses (at therapeutic doses) required in CMV seropositive (+) recipients awaiting kidney transplant.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who meet all of the following key inclusion criteria will be eligible to participate in the study: Male or female patients 18 years of age or older. Patients must be eligible to undergo kidney transplantation from a living donor as per institutional standards. For Groups 1 and 2 only: Patients must be CMV immunoglobulin G (IgG) seronegative (-) and receiving kidney for transplantation from donors who are CMV IgG seropositive (+). For Group 3 only: Patients must be CMV immunoglobulin G (IgG) seropositive (+) and receiving kidney for transplantation from donors who are either CMV IgG seronegative (-) or seropositive (+). Patients who would comply with the requirements of this protocol (e.g., return for follow up visits), as judged by the investigator. Exclusion Criteria: Patients who meet any of the following key criteria will be excluded from the study: Patients planning to undergo multi-organ transplantation. Patients participating in another interventional clinical study. Previous vaccination with an investigational CMV vaccine. Any confirmed or suspected immunodeficiency disorder (based on medical history and physical examination) that could interfere with the immune response or that presents a risk for the patient to receive a vaccine candidate in development. Treatment with any chronic immunosuppressive medication or other immuno modifying drugs within 6 months prior to study entry. However, inhaled and topical steroids and low-dose oral corticosteroids (<10 milligrams a day of prednisone or equivalent) are allowed. Prior history of CMV disease or CMV infection requiring anti-viral therapy Patients with a rash, dermatological condition, or tattoo in the area of the injection site(s) that could interfere with administration site reaction rating. (Note: The injection site(s) can be the non-dominant arm [most preferred injection site], dominant arm, or either thigh [least preferred injection site], as judged by the investigator). It is anticipated that the patient will be unavailable to complete the study follow-up. Patients who are highly sensitized or who are likely to undergo desensitization at time of transplant (e.g., donor-specific antibody titers at the local laboratory >2000).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
Hookipa Biotech GmbH
Official's Role
Study Director
Facility Information:
Facility Name
The 1917 Clinic at UAB
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
California Institute of Renal Research
City
La Mesa
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
UC Davis Health Systems
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Indiana University/IU Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati (UC) - College of Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Oklahoma University
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Thomas E. Starzl Transplantation Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
South Texas Accelerated Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Centre Hospitalier Universitaire de Bordeaux Hôpital Pellegrin
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Hopital Necker-Enfants Malades
City
Paris
ZIP/Postal Code
75743
Country
France
Facility Name
CHU de Toulouse - Hospital Rangueil
City
Toulouse
ZIP/Postal Code
31400
Country
France
Facility Name
Charite Universitatsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitatsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Facility Name
Belfast Health and Social Care Trust
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Cardiff & Vale University Health Board
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
St James's University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Leicester General Hospital
City
Leicester
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
The Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of CMV Vaccine (HB-101) in Kidney Transplant Patients

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