The Food and Drug Administration recently approved the first human clinical trial of a vaccine created at City of Hope that may bring vulnerable patients much-needed protection from infection by a common but potentially deadly virus.
Don J. Diamond, Ph.D., director of the Laboratory of Vaccine Research, received approval to immediately start a phase I clinical trial to test the safety of the vaccine, which may help protect patients who have undergone hematopoietic cell transplants from cytomegalovirus, or CMV.
“This clinical trial is the culmination of close to a decade of research and development into the CMV peptide,” said Diamond. “Our goal is to replace the current standard therapy, ganciclovir, which is toxic, with the less-toxic vaccine.”
The vaccine consists of a combination of two small molecules called peptides. One peptide acts as a vehicle or general stimulant for the other, which is a peptide specific to CMV. Researchers believe the vaccine will stoke the body to boost immunity against CMV.
Diamond’s work with the CMV peptide began in 1997 under the aegis of the hematology program, directed by Stephen J. Forman, M.D., the Francis and Kathleen McNamara Distinguished Chair in Hematology and Hematopoietic Cell Transplantation.
CMV is a common type of herpes virus that infects from 50 to 80 percent of adults in the United States by age 40 and a similar percentage worldwide. It apparently causes no symptoms in most healthy adults and usually remains dormant. But in people with weakened or compromised immune systems, such as patients who have undergone hematopoietic cell transplants, CMV can reactivate and cause life-threatening pneumonia and other diseases.
“In the beginning days of the bone marrow transplantation program, CMV infection was the cause of the majority of patient deaths,” said Diamond. “To control the possibility of CMV infection more effectively with fewer side effects, perhaps even eliminate it, would be a great benefit to all transplantation patients.”
City of Hope is enrolling healthy volunteers who either have or have not had a CMV infection to participate in the one-year study of two different forms of the CMV peptide vaccine. The safety trials will determine which form of the vaccine has milder side effects, and possibly hint at which one is preferable for patients. The vaccine is specific to people who carry or react to a specific type of molecule (or human leukocyte antigen type) found in about 40 percent of the transplant population.
“If we’re successful with this first target antigen, then we can develop and test versions that will cover up to 80 percent of the transplant population,” said Diamond.
The vaccine’s implications may eventually reach beyond hematopoietic cell transplant patients, as well. Others vulnerable to CMV include patients susceptible to vascular disease, those in need of a lung, liver or kidney transplant, and those with HIV. Babies infected with CMV at birth or when very young, too, may face disabilities and might one day benefit from this or other vaccines in development.
Collaborators on the vaccine project include John A. Zaia, M.D., professor and chair of the Division of Virology and principal investigator of the phase I clinical trial, Corinna La Rosa, Ph.D., assistant research scientist, the General Clinical Research Center at City of Hope, and the nursing staff in the Department of Transfusion Medicine.
When the vaccine is made available to City of Hope transplant patients, the Division of Hematology & Hematopoietic Cell Transplantation, under Forman’s direction, will supervise the clinical trial, Diamond said. The division’s physicians and nurses will be vital to the vaccine’s successful evaluation, he added.
To find out more information about the clinical trial or how to participate, call 877-482-HOPE (4673) or visit City of Hope’s clinical trials Web site at http://clinicaltrials.coh.org.