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

NCT03629080 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2023-10-26

Study results available
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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).

Conditions

  • Cytomegalovirus (CMV) Infection
  • Kidney Transplantation

Interventions

BIOLOGICAL

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.

BIOLOGICAL

placebo

Saline will be used for placebo.

Sponsors & Collaborators

  • Hookipa Biotech GmbH

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer · Hookipa Biotech GmbH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-12
Primary Completion
2022-06-22
Completion
2022-06-22
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • France
  • Germany
  • Norway
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03629080 on ClinicalTrials.gov