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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT03629080

Public ClinicalTrials.gov record NCT03629080. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 12:04 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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+).

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT03629080
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Hookipa Biotech GmbH
Industry
Enrollment
83 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
18 Years to 99 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 12, 2018 (Actual)
Primary completion
Jun 22, 2022 (Actual)
Completion
Jun 22, 2022 (Actual)
Last update posted
Oct 26, 2023

2018 – 2022

United States locations

U.S. sites
13
U.S. states
10
U.S. cities
12
Facility City State ZIP Site status
The 1917 Clinic at UAB Birmingham Alabama 35205 —
California Institute of Renal Research La Mesa California 92123 —
UC Davis Health Systems Sacramento California 95817 —
University of Colorado Hospital Aurora Colorado 80045 —
Indiana University/IU Health Indianapolis Indiana 46202 —
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 —
Oklahoma University Oklahoma City Oklahoma 73104 —
Thomas E. Starzl Transplantation Institute Pittsburgh Pennsylvania 15213 —
South Texas Accelerated Research Dallas Texas 75390 —
Swedish Medical Center Seattle Washington 98104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03629080, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 26, 2023 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03629080 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →