Pfizer has launched a Phase 3 study of its RSV vaccine candidate and researchers at the George Washington University are studying the vaccine’s safety and ability to trigger an immune response in two groups of people at risk for severe illness caused by respiratory syncytial virus or RSV.
Earlier this month, the U.S. Food and Drug Administration (FDA) approved the first vaccine for RSV. The vaccine, which is made by GlaxoSmithKline, received FDA approval for the prevention of illness caused by RSV in adults aged 60 and older. The FDA is expected to consider Pfizer’s vaccine candidate for approval in the prevention of lower respiratory tract disease caused by RSV in adults 60 and older.
“RSV can be a serious and potentially deadly illness, especially for adults with chronic medical conditions,” said Elissa Malkin, assistant research professor of medicine at the GW Vaccine Research Unit at the School of Medicine and Health Sciences (SMHS). “Public health officials hope to have more than one approved RSV vaccine this fall to help combat the expected surge of the virus.”
Malkin is the principal investigator of the RSV study.
Older adults and premature infants are especially at risk for RSV. According to the Centers for Disease Control and Prevention, RSV kills 10,000 people ages 65 and older and up to 300 children under age 5 every year in the United States.
The GW Vaccine Research Unit is located at the SMHS and the GW Medical Faculty Associates. The GW Vaccine Research Unit conducts clinical trials of experimental products that are being developed for the prevention of infectious diseases such as COVID-19, HIV and others.
Malkin and her colleagues will study two subsets of volunteers, including adults aged 18-59 with a chronic medical condition such as diabetes, heart disease or some other health issue that puts them at risk of hospitalization or even death as a result of RSV infection.
In the second subset, the GW researchers will recruit adults aged 18 and older who are immunocompromised-usually because they are taking immunosuppressive drugs for a medical condition such as autoimmune disease or organ transplant.
In both cases, the GW team hopes to show that the RSV vaccine is safe and well-tolerated. Malkin said they will also look to see that the RSV vaccine triggers an immune response in both sets of recruits. Other studies of the Pfizer vaccine have demonstrated that it protects against RSV disease in older adults.