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

NCT ID: NCT03629080

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-12
• Study Completion Date: 2022-06-22

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.

Conditions

Cytomegalovirus (CMV) Infection; Kidney Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

HB-101 vaccine preemptive

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.

Group Type: EXPERIMENTAL

HB-101 vaccine

Intervention Type: BIOLOGICAL

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.

Placebo preemptive

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: BIOLOGICAL

Saline will be used for placebo.

HB-101 vaccine prophylactic

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.

Group Type: EXPERIMENTAL

HB-101 vaccine

Intervention Type: BIOLOGICAL

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.

Placebo prophylactic

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: BIOLOGICAL

Saline will be used for placebo.

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

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.

Group Type: EXPERIMENTAL

HB-101 vaccine

Intervention Type: BIOLOGICAL

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.

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

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.

Group Type: EXPERIMENTAL

HB-101 vaccine

Intervention Type: BIOLOGICAL

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.

Interventions

HB-101 vaccine

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

placebo

Saline will be used for placebo.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hookipa Biotech GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chief Medical Officer

Role: STUDY_DIRECTOR

Hookipa Biotech GmbH

Locations

The 1917 Clinic at UAB

Birmingham, Alabama, United States

California Institute of Renal Research

La Mesa, California, United States

UC Davis Health Systems

Sacramento, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

Indiana University/IU Health

Indianapolis, Indiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

The Christ Hospital

Cincinnati, Ohio, United States

University of Cincinnati (UC) - College of Medicine

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Oklahoma University

Oklahoma City, Oklahoma, United States

Thomas E. Starzl Transplantation Institute

Pittsburgh, Pennsylvania, United States

South Texas Accelerated Research

Dallas, Texas, United States

Swedish Medical Center

Seattle, Washington, United States

Odense University Hospital

Odense, , Denmark

Centre Hospitalier Universitaire de Bordeaux Hôpital Pellegrin

Bordeaux, , France

Hopital Necker-Enfants Malades

Paris, , France

CHU de Toulouse - Hospital Rangueil

Toulouse, , France

Charite Universitatsmedizin Berlin

Berlin, , Germany

Universitatsklinikum Essen

Essen, , Germany

Oslo University Hospital

Oslo, , Norway

Belfast Health and Social Care Trust

Belfast, , United Kingdom

Cardiff & Vale University Health Board

Cardiff, , United Kingdom

St James's University Hospital

Leeds, , United Kingdom

Leicester General Hospital

Leicester, , United Kingdom

The Royal Free Hospital

London, , United Kingdom

Countries

United States; Denmark; France; Germany; Norway; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-005047-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

H-100-002

Identifier Type: -

Identifier Source: org_study_id