Cytomegalovirus (CMV) InfectionPhase 2NCT03629080
A Study of CMV Vaccine (HB-101) in Kidney Transplant Patients
A Phase 2 study testing HB-101 vaccine in people with Cytomegalovirus (CMV) Infection and Kidney Transplantation, run by Hookipa Biotech GmbH at 25 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cytomegalovirus (CMV) Infection, Kidney Transplantation
- What is being tested?
- HB-101 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 25 sitesin 6 countries
- Study dates
- 12 Dec 2018to 22 Jun 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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).
Trial locations and contacts
25 sites in 6 countries.
25 sites in 6 countries
United States13 sites
University of Colorado Hospital
Aurora, Colorado, 80045
The 1917 Clinic at UAB
Birmingham, Alabama, 35205
Massachusetts General Hospital
Boston, Massachusetts, 02114
The Christ Hospital
Cincinnati, Ohio, 45219
University of Cincinnati (UC) - College of Medicine
Cincinnati, Ohio, 45267
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
South Texas Accelerated Research
Dallas, Texas, 75390
Indiana University/IU Health
Indianapolis, Indiana, 46202
California Institute of Renal Research
La Mesa, California, 92123
Oklahoma University
Oklahoma City, Oklahoma, 73104
Thomas E. Starzl Transplantation Institute
Pittsburgh, Pennsylvania, 15213
UC Davis Health Systems
Sacramento, California, 95817
Swedish Medical Center
Seattle, Washington, 98104
United Kingdom5 sites
Belfast Health and Social Care Trust
Belfast, BT9 7AB
Cardiff & Vale University Health Board
Cardiff, CF14 4XW
St James's University Hospital
Leeds, LS9 7TF
Leicester General Hospital
Leicester, LE5 4PW
The Royal Free Hospital
London, NW3 2QG
France3 sites
Centre Hospitalier Universitaire de Bordeaux Hôpital Pellegrin
Bordeaux, 33076
Hopital Necker-Enfants Malades
Paris, 75743
CHU de Toulouse - Hospital Rangueil
Toulouse, 31400
Germany2 sites
Charite Universitatsmedizin Berlin
Berlin, 10117
Universitatsklinikum Essen
Essen, 45147
About this study
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+).
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).
Read the 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.
- Being tested
- HB-101 vaccine, placebo
- Keywords
- solid organ transplantation, vaccine
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB-101 vaccineBiological
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.
placeboBiological
Saline will be used for placebo.
| Study group | Role | What they receive |
|---|---|---|
| HB-101 vaccine preemptive | Experimental | 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. Receives: Biological: HB-101 vaccine |
| Placebo preemptive | Placebo comparator | 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. Receives: Biological: placebo |
| HB-101 vaccine prophylactic | Experimental | 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. Receives: Biological: HB-101 vaccine |
| Placebo prophylactic | Placebo comparator | 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. Receives: Biological: placebo |
| HB-101 vaccine: CMV (+) patients-Prophylactic Management | Experimental | 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. Receives: Biological: HB-101 vaccine |
| HB-101 vaccine: CMV (+) patients-Preemptive Management | Experimental | 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. Receives: Biological: HB-101 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events and Serious Adverse Events
Assess the number and severity of participants with adverse events and serious adverse events
Measured: 15 Months
Assessment of Humoral Immunogenicity Analyses
Assessment of CMV neutralizing antibody titers (NTAs) at day of Transplant defined by log10 virus neutralising unit(s)
Measured: 15 Months
Number of Patients With Injection Site Events.
Number of patients experiencing a local or generalized injection site reaction
Measured: 15 Months
Change of Oral Body Temperature.
Oral body temperature was measured in degrees Celsius prior to study drug administrations and seven days after. The results express the change from baseline (defined as the last measurement prior to the first dose of study drug) to Dose 3.
Measured: Change from Baseline to 7 days after study drug administration of Dose 3. Three (3) months
Change of Respiration Rate.
Respiration rate in breaths per minute was measured prior to study drug administration and seven days after. The results express the change from baseline (defined as the last measurement prior to the first dose of study drug) to Dose 3.
Measured: Change from Baseline to 7 days after study drug administration of Dose 3. Three (3) months.
Change of Blood Pressure.
Diastolic and Systolic Blood Pressure was measured in millimeters of mercury (mmHg) prior to study drug administration and seven days after. The results express the change from baseline (defined as the last measurement prior to the first dose of study drug) to Dose 3.
Measured: Change from Baseline to 7 days after study drug administration of Dose 3. Three (3) months
Assessment of Cellular Immunogenicity Analyses
Assessment of positive CMV IFNγ ELISPOT results for pp65 and gB defined by Spot forming cells / mio PBMC per CMV Management Strategy and Doses Before Transplant
Measured: 15 months
Secondary outcomes (7)
Time to Clinically Significant CMV Infection.
Measure the time to clinically significant CMV infection, CMV disease, and CMV syndrome. Time to infection was defined as the number of days of the first quantifiable result above the LLOQ monitored for 12 months after transplantation.
Measured: 12 months
Number of Participants With CMV Viremia Requiring Anti Viral Therapy
Measure the number of patients with 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.
Measured: 12 months
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.
Measured: 12 months
Number of Participants Requiring Anti-CMV Therapy
Measure the number of participants requiring anti-CMV therapy (at therapeutic doses) in CMV seropositive (+) recipients awaiting kidney transplant.
Measured: 12 months
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.
Measured: 12 months
Number of Participants With Organ Rejection
Assessment of number of participants with graft failure leading to biopsy-confirmation rejection of organ post transplantation.
Measured: Up to 12 months post transplantation
Time to Organ Rejection
Measurement of time (in days) between transplantation and graft failure leading to biopsy-confirmation rejection of organ
Measured: Up to 12 months post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start12 Dec 2018
- Primary completion22 Jun 2022
- Study completion22 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cytomegalovirus (CMV) InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hookipa Biotech GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Hookipa Biotech GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629080
- Sponsor's protocol ID
- H-100-002
- Other IDs
- 2017-005047-32, 2017
- Status last verified
- Oct 2023
- First submitted
- 29 May 2018
- Last updated
- 26 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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+).
- ClinicalTrials.gov ID
- NCT03629080
- Acronym / sponsor ID
- H-100-002
- Keywords
- solid organ transplantation, vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Hookipa Biotech GmbHIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Posted 26 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
- 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.
| Arm | Type | Receives |
|---|---|---|
| HB-101 vaccine preemptive | Experimental | Biological: HB-101 vaccineThree 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. |
| Placebo preemptive | Placebo comparator | Biological: placeboThree 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. |
| HB-101 vaccine prophylactic | Experimental | Biological: HB-101 vaccineThree 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. |
| Placebo prophylactic | Placebo comparator | Biological: placeboThree 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. |
| HB-101 vaccine: CMV (+) patients-Prophylactic Management | Experimental | Biological: HB-101 vaccineThree 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. |
| HB-101 vaccine: CMV (+) patients-Preemptive Management | Experimental | Biological: HB-101 vaccineThree 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 (+).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HB-101 vaccineHB-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. | Biological | HB-101 vaccine preemptive, HB-101 vaccine prophylactic, HB-101 vaccine: CMV (+) patients-Preemptive Management, HB-101 vaccine: CMV (+) patients-Prophylactic Management |
| placeboSaline will be used for placebo. | Biological | Placebo preemptive, Placebo prophylactic |
Primary outcome
Number of Participants With Adverse Events and Serious Adverse Events
Time frame: 15 Months
Assess the number and severity of participants with adverse events and serious adverse events
Assessment of Humoral Immunogenicity Analyses
Time frame: 15 Months
Assessment of CMV neutralizing antibody titers (NTAs) at day of Transplant defined by log10 virus neutralising unit(s)
Number of Patients With Injection Site Events.
Time frame: 15 Months
Number of patients experiencing a local or generalized injection site reaction
Change of Oral Body Temperature.
Time frame: Change from Baseline to 7 days after study drug administration of Dose 3. Three (3) months
Oral body temperature was measured in degrees Celsius prior to study drug administrations and seven days after. The results express the change from baseline (defined as the last measurement prior to the first dose of study drug) to Dose 3.
Change of Respiration Rate.
Time frame: Change from Baseline to 7 days after study drug administration of Dose 3. Three (3) months.
Respiration rate in breaths per minute was measured prior to study drug administration and seven days after. The results express the change from baseline (defined as the last measurement prior to the first dose of study drug) to Dose 3.
Change of Blood Pressure.
Time frame: Change from Baseline to 7 days after study drug administration of Dose 3. Three (3) months
Diastolic and Systolic Blood Pressure was measured in millimeters of mercury (mmHg) prior to study drug administration and seven days after. The results express the change from baseline (defined as the last measurement prior to the first dose of study drug) to Dose 3.
Assessment of Cellular Immunogenicity Analyses
Time frame: 15 months
Assessment of positive CMV IFNγ ELISPOT results for pp65 and gB defined by Spot forming cells / mio PBMC per CMV Management Strategy and Doses Before Transplant
7 secondary outcomes
Time to Clinically Significant CMV Infection.
Time frame: 12 months
Number of Participants With CMV Viremia Requiring Anti Viral Therapy
Time frame: 12 months
The Time to CMV Viremia Requiring Anti Viral Therapy.
Time frame: 12 months
Number of Participants Requiring Anti-CMV Therapy
Time frame: 12 months
The Duration of Anti-CMV Therapy Courses Required.
Time frame: 12 months
Number of Participants With Organ Rejection
Time frame: Up to 12 months post transplantation
Time to Organ Rejection
Time frame: Up to 12 months post transplantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cytomegalovirus (CMV) Infection
RecruitingObservational study
A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
Cytomegalovirus (CMV)
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
RecruitingPhase 2
CMV CTLs in Neonates With CMV Infection
Congenital Cytomegaloviral (CMV) Disease
RecruitingPhase 2
Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)
Cytomegalovirus Infections, Primary Immune Deficiency Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Medical Officer study director
Hookipa Biotech GmbH
25 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HB-101 vaccine in people with Cytomegalovirus (CMV) Infection and Kidney Transplantation, run by Hookipa Biotech GmbH at 25 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, United Kingdom, France, Germany, Denmark and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events and Serious Adverse Events (time frame: 15 Months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.