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Cancer Vaccine

HB-101 vaccine for Cytomegalovirus

Phase 2
Waitlist Available
Led By Igor Matushansky
Research Sponsored by Hookipa Biotech GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months
Awards & highlights

Study Summary

This study is evaluating whether a vaccine may help prevent CMV infection in kidney transplant patients.

Eligible Conditions
  • Cytomegalovirus
  • Kidney Transplant

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of Cellular Immunogenicity Analyses
Assessment of Humoral Immunogenicity Analyses
Change of Blood Pressure.
+4 more
Secondary outcome measures
Number of Participants Requiring Anti-CMV Therapy
Number of Participants With CMV Viremia Requiring Anti Viral Therapy
Number of Participants With Organ Rejection
+4 more

Side effects data

From 2022 Phase 2 trial • 83 Patients • NCT03629080
75%
Anemia
50%
Calcium Deficiency
25%
Neuropathic Arthropathy
25%
Urethral Spasm
25%
Folate Deficiency
25%
DM Inadequate Control
25%
Renal Impairment
25%
UTI
25%
Muscle Spasms
25%
Dysphagia
25%
Metabolic Acidosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
HB-101 Vaccine: CMV (+) Patients-Preemptive Management
HB-101 Vaccine Preemptive
HB-101 Vaccine Prophylactic
Placebo Preemptive
Placebo Prophylactic
HB-101 Vaccine: CMV (+) Patients-Prophylactic Management

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: HB-101 vaccine: CMV (+) patients-Prophylactic ManagementExperimental Treatment1 Intervention
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 II: HB-101 vaccine: CMV (+) patients-Preemptive ManagementExperimental Treatment1 Intervention
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 III: HB-101 vaccine prophylacticExperimental Treatment1 Intervention
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 IV: HB-101 vaccine preemptiveExperimental Treatment1 Intervention
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 V: Placebo prophylacticPlacebo Group1 Intervention
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 VI: Placebo preemptivePlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HB-101 vaccine
2018
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

Hookipa Biotech GmbHLead Sponsor
5 Previous Clinical Trials
385 Total Patients Enrolled
Igor MatushanskyPrincipal InvestigatorHookipa Biotech GmbH
Chief Medical OfficerStudy DirectorHookipa Biotech GmbH
122 Previous Clinical Trials
21,441 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of CMV Vaccine (HB-101) in Kidney Transplant Patients
2018. "A Study of CMV Vaccine (HB-101) in Kidney Transplant Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03629080.
~13 spots leftby Apr 2025
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