A vaccine that Novavax developed to deter the virus that causes most lung infections generated the desired immune response in children, and was safe, according to clinical trials.
The trials dealt with the RSV F vaccine’s ability to protect older adults and children from the respiratory syncytial virus, or RSV. The studies also showed that the vaccine significantly reduced hospitalizations stemming from chronic obstructive pulmonary disease exacerbations.
RSV is the most common cause of lower respiratory tract infections in the United States, and the leading cause of older-adult and infant hospitalizations. With no approved vaccines for the virus, it is also the second leading cause of death among children under the age of 1 worldwide.
Novavax used a new approach to developing the vaccine: engineering small particles that carry altered RSV proteins. The nanoparticles sensitize the immune system to the virus, so that when a person comes in contact with it, the immune system delivers a robust response.
Preclinical-trial studies have shown RSV F to be better than the approved vaccine Synagis (palivizumab) at preventing infection in children.
Novavax is in the midst of conducting a Phase 1 clinical trial (NCT02296463) of RSV F in people older than 60 and children between 6 months and 5 years.
Two completed trials — a Phase 2 (NCT02266628) and a Phase 3 (NCT02608502) — showed that RSV F reduced hospitalizations stemming from COPD exacerbations by 61 percent. The flares worsen patients’ condition and are costly.
Based on these findings, Novavax plans a Phase 2 trial in 2018 on the vaccine’s ability to prevent COPD exacerbations in older people.
The company is continuing to conduct a Phase 2 trial (NCT03026348) of the vaccine’s safety and ability to provoke an immune response in older people. The 300 people in the study are receiving either the vaccine or a placebo. Researchers have administered the vaccine either alone or with a compound designed to increase its punch: aluminum phosphate or Novavax’s proprietary Matrix-M.
Both of the compounds significantly improved the vaccine’s effectiveness. The results support the use of what scientists call adjuvant compounds to increase the vaccine’s clout.
Novavax is collaborating with the Bill and Melinda Gates Foundation to test whether immunizing pregnant women can protect their children from the virus. Healthy pregnant women are being recruited at several research sites for the Phase 3 PREPARE trial (NCT02624947).
“The new data that further characterizes the RSV F Vaccine and the benefit of adjuvants, combined with the hospitalization data in the COPD population, places us in a strong position” to obtain RSV-program partners, Stanley C. Erck, president and CEO of Novavax, said in a press release. “We also look forward to continued momentum in PREPARE trial enrollment and to developing our plans for the next steps in our RSV older-adult program over the next 12 months.”