Summary

for people ages 18-99 (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Flavio Vincenti

Description

Summary

HB-101 is a bivalent recombinant vaccine against human CMV infection. In this phase 2 study, adult CMV-Seronegative patients awaiting kidney transplant from a CMV-Seropositive living donor will be enrolled into 1 of 2 treatment arms according to treatment intent (HB-101 or placebo) with regard to the method of CMV prevention after transplant (either preemptive or with an anti-viral prophylaxis). 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).

Official Title

A Randomized, Placebo-Control, 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+).

Details

This is a randomized, placebo-controlled, phase 2 study is 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. 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.

Keywords

Cytomegalovirus (CMV) Infection Kidney Transplantation solid organ transplantation vaccine Vaccines HB-101 vaccine HB-101 vaccine preemptive HB-101 vaccine prophylactic

Eligibility

You can join if…

Open to people ages 18-99

Patients who meet all of the following inclusion criteria will be eligible to participate in the study:

  1. Male or female patients 18 years of age or older.
  2. Patients must be eligible to undergo kidney transplantation from a living donor as per institutional standards.
  3. Patients must be CMV immunoglobulin G (IgG) seronegative (-) and receiving kidney for transplantation from donors who are CMV IgG seropositive (+).
  4. Patients who would comply with the requirements of this protocol (e.g., return for follow up visits), as judged by the investigator.

You CAN'T join if...

Patients who meet any of the following criteria will be excluded from the study:

  1. Patients planning to undergo multi-organ transplantation.
  2. Patients participating in another interventional clinical study.
  3. Previous vaccination with an investigational CMV vaccine.
  4. 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.
  5. 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.
  6. Prior history of CMV disease or CMV infection requiring anti-viral therapy
  7. 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).
  8. It is anticipated that the patient will be unavailable to complete the study follow-up.

Locations

  • California Pacific Medical Center accepting new patients
    San Francisco California 94115 United States
  • California Institute of Renal Research accepting new patients
    La Mesa California 92123 United States

Lead Scientist

  • Flavio Vincenti
    Professor, Medicine. Authored (or co-authored) 255 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hookipa Biotech
ID
NCT03629080
Phase
Phase 2
Study Type
Interventional
Last Updated