The Phase 1 data showed that the vaccine has a good safety profile, was well tolerated, and elicited strong humoral and cellular immune responses.
The data will be presented by Camille Kotton, M.D., Clinical Director, Transplant and Immunocompromised Host Infectious Disease at Massachusetts General Hospital. Further details of the presentation are below:
Title: A CMV Vaccine Based on Non-Replicating Lymphocytic Choriomeningitis Virus Vectors Expressing gB and pp65 is Safe and Immunogenic in Healthy Volunteers and Entering a Phase 2 Trial in Kidney Transplant Recipients
Publication Number: 330
Session Date & Time: Monday, June 3, 2019, 4:30 pm - 6:00 pm EST
Session Location: Ballroom A, John B. Hynes Convention Center
The abstract for the presentation is available on the ATC website here.
HB-101 is a VaxWave®*-based product candidate designed to stimulate the immune system against cytomegalovirus and to protect against future cytomegalovirus infection or reactivation from latency.
In 2018, HOOKIPA commenced a randomized, placebo-controlled, Phase 2 clinical trial for HB-101 in cytomegalovirus-negative patients awaiting kidney transplantation from living cytomegalovirus-positive donors. We expect safety and immunogenicity data from the first cohorts enrolled in this trial in the first half of 2020, and preliminary efficacy data to follow in the second half of 2020.
Cytomegalovirus (CMV) is a virus that is commonly transmitted in childhood and early adulthood. A majority of the U.S. population has been exposed and is latently infected. Worldwide data indicate that while half the people in industrialized countries have been exposed, up to 99% of people in developing countries, including China and India, have been exposed.
Infections result in lifelong latent persistence of the virus with few symptoms, if any. However, in unborn children, when infected in utero, CMV infection can lead to significant morbidity and mortality. In addition, in immunosuppressed patients, such as transplant recipients, primary cytomegalovirus infection or reactivation causes significant morbidity, mortality and graft rejection. There are two scenarios in which cytomegalovirus infections are relevant in the transplant setting. In one case, the recipient could be cytomegalovirus negative, or previously uninfected, and the donor cytomegalovirus positive. In this case, introduction of cytomegalovirus into the immunocompromised recipient can lead to rapid virus spread and development of serious complications. In the other case, the recipient is already cytomegalovirus positive, but the immunosuppressive treatments required as part of the transplant procedure lead to reactivation of latent virus.