Physician/researchers at Emory University and Children’s Healthcare of Atlanta have begun vaccinating children in a clinical trial testing an investigational H1N1 (swine flu) vaccine along with the seasonal flu vaccine. Up to 650 children nationally will participate in the study, and Emory will enroll approximately 100 children, ages six months to 18 years.
The clinical trial is being conducted within the Vaccine and Treatment Evaluation Units (VTEUs), supported by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH). At Emory, the VTEU is led by Mark Mulligan, MD, executive director of the Hope Clinic of the Emory Vaccine Center.
The study will examine the safety of and measure the body’s immune response to the H1N1 flu vaccine. In addition, it will help determine how and when the vaccine should be given with the seasonal flu vaccine to make it most effective. It also will analyze potential problems of giving the vaccines together, such as whether one vaccine will undermine the protective power of the other.
The answer is important because experts are predicting that both strains of influenza will circulate this fall and winter.
The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recently recommended all people from six months through 24 years of age receive the H1N1 influenza vaccine when it is available. In making its recommendations, the group considered current disease patterns and current trends that showed populations most at risk of serious illness, among other factors.
The panel recommended vaccinating children between six months and 18 years because of the high number of cases of H1N1 influenza infection in that age group. In addition, because they frequently are in school and day care, they are in close contact with each other, making it easier to spread disease.
The Emory pediatric clinical trial will be conducted at the Emory-Children’s Center. The trial is being led by Emory VTEU co-directors Harry Keyserling, MD, professor of pediatric infectious diseases at Emory School of Medicine and Paul Spearman, MD, chief research officer for Children’s Healthcare of Atlanta and vice chair of research for Emory’s Department of Pediatrics, along with Allison Ross, MD, Emory assistant professor of pediatric infectious diseases.
The pediatric trial follows the launch of a VTEU-led adult clinical trial of the H1N1 and seasonal flu vaccines, which began at Emory’s Hope Clinic on Aug. 10 and will continue with followup visits for the next six weeks by a group of more than 170 volunteers.
“Because children and young adults are considered among the most vulnerable populations for new and emerging strains of influenza, such as the current H1N1 pandemic, it is critically important that we quickly and efficiently conduct these tests for a vaccine,” says Keyserling,
In addition to Emory, other sites for the H1N1 pediatric study, which is led by Saint Louis University, are Baylor College of Medicine, Houston; Children’s Hospital Medical Center in Cincinnati; University of Texas Medical Branch at Galveston; and the University of Iowa.
The VTEUs were established in 1962 as a vital research component of the NIAID. The units conduct clinical trials for all infectious diseases other than HIV/AIDS. They have conducted hundreds of clinical studies over the past four decades. Emory was designated a VTEU site in 2007 and received a seven-year contract of approximately $23.7 million.
An important strength of the VTEUs is their ability to rapidly enroll large numbers of volunteers into trials and to immunize the volunteers in a safe, effective and efficient manner. This rapid-response capability is especially important for testing vaccines designed to combat pandemic influenza. Results are expected to be available weeks after the trials begin.
For more information on this clinical study visit http://clinicaltrials.gov/show/NCT00943202.
For more information about the Emory pediatric clinical trial, call 404-727-4044.