Phase 2
N=83
A Study of CMV Vaccine (HB-101) in Kidney Transplant Patients
Cytomegalovirus (CMV) Infection · Kidney Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT03629080 ↗Enrolled (actual)
83
Serious AEs
37.5%
Results posted
Oct 2023
Primary outcome: Primary: Number of Participants With Adverse Events and Serious Adverse Events — 6; 3; 23; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- HB-101 vaccine (Biological); placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hookipa Biotech GmbH
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events and Serious Adverse Events |
6; 3; 23; 12; 6; 3 | — |
| PRIMARY Assessment of Humoral Immunogenicity Analyses |
0.8; 0.6; 0.8; 0.8; 2.6; 2.5 | — |
| PRIMARY Number of Patients With Injection Site Events. |
1; 0; 4; 4; 2; 1 | — |
| PRIMARY Change of Oral Body Temperature. |
-0.0; -0.1; 0.2; -0.3; 0.6; -0.2 | — |
| PRIMARY Change of Respiration Rate. |
0.5; 0.0; 0.2; -0.6; 2.0; -4.0 | — |
| PRIMARY Change of Blood Pressure. |
0.5; 2.0; 2.6; 1.3; 6.0; 6.0 | — |
| PRIMARY Assessment of Cellular Immunogenicity Analyses |
83.0; 30.7; 15.0; 95.3; 15.0; 4145.0 | — |
| SECONDARY Time to Clinically Significant CMV Infection. |
50.2; 83.0; 256.2; 248.0; 171.0; 15.0 | — |
| SECONDARY Number of Participants With CMV Viremia Requiring Anti Viral Therapy |
5; 2; 5; 2; 1; 1 | — |
| SECONDARY The Time to CMV Viremia Requiring Anti Viral Therapy. |
53.6; 129.0; 259.2; 259.0; 171.0; 15.0 | — |
| SECONDARY Number of Participants Requiring Anti-CMV Therapy |
5; 2; 4; 2; 1; 1 | — |
| SECONDARY The Duration of Anti-CMV Therapy Courses Required. |
154.2; 89.0; 87.0; 72.0; 198.0; 20.0 | — |
| SECONDARY Number of Participants With Organ Rejection |
1; 0; 3; 1; 0; 0 | — |
| SECONDARY Time to Organ Rejection |
59.0; 126.3; 34.0 | — |
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).
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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 ( 2000).
Data sourced from ClinicalTrials.gov (NCT03629080). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.