Abrysvo Looks Promising for RSV Protection in Immunocompromised Adults

Positive topline data were announced from a phase 3 study evaluating Abrysvo^® (respiratory syncytial virus [RSV] vaccine) in immunocompromised adults.

Substudy B of the MONeT trial (ClinicalTrials.gov Identifier: NCT05842967) assessed the safety and immunogenicity of Abrysvo in immunocompromised adults at risk of developing severe RSV-associated lower respiratory tract disease (LRTD). The study included 4 cohorts: 1) patients with non-small cell lung cancer; 2) patients on hemodialysis due to end-stage renal disease; 3) patients with an autoimmune inflammatory disorder (eg, inflammatory arthritis, inflammatory bowel disease) receiving immunomodulator therapy; and 4) solid organ transplant recipients. Study participants (N=203) received 2 doses of Abrysvo administered 1 month apart.

Findings showed following a single 120µg dose, Abrysvo generated a strong neutralizing response against both RSV-A and RSV-B. This response was observed across all cohorts and age groups in the study; approximately half of the participants were aged 60 years and older. The vaccine was found to be well tolerated and had a safety profile consistent with previous clinical trials evaluating Abrysvo. According to Pfizer, additional results from substudy B will be presented at an upcoming scientific meeting. 

“Immunocompromised adults, such as patients with cancer or autoimmune disorders, have a substantially increased risk of experiencing severe complications from RSV, yet there are currently no vaccines approved for those aged 18 to 59 in the US,” said Annaliesa Anderson, PhD, Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “We are encouraged by the positive top-line data from this study, which provide important evidence that Abrysvo has the potential to address a significant unmet need in this vulnerable population.”

Abrysvo is currently indicated for active immunization for the prevention of LRTD caused by RSV in individuals 60 years of age and older. It is also approved for active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age.

This article originally appeared on MPR